Circumferential Teeth Spear for 3.9 mm Knotless Corkscrew Anchor, and 2.6 FiberTak Anchors

Spear mit gezahnter Spitze, für 3.9 mm Knotless Corkscrew

Circumferential Teeth Guide for 3.9 mm Knotless Corksrews

Finished Product

AR-1941CT

Shoulder

Procedure

As the next evolution of knotless rotator cuff repair, the FiberTak SpeedBridge™ technique is completed with 2.6 FiberTak RC soft anchors on the medial row and FiberTape® sutures fixated laterally with trusted SwiveLock® anchors.
This knotless repair creates a quick, secure construct in as few as three suture-passing steps. The small size of the 2.6 FiberTak RC anchors allows for three points of medial-row fixation where previously only two fixation points could be achieved.
Knotless 2.6 FiberTak RC anchors are adaptable and can conform to traditional repair techniques while providing the additional benefits of tensionable knotless technology for incorporating biologics or increasing medial-row compression.

FiberTak® SpeedBridge™ repair is the next evolution of knotless rotator cuff repair using self-punching 2.6 FiberTak RC soft anchors for the medial row and trusted Knotless Swivelock® suture anchors for lateral fixation. The FiberTak RC anchors feature a fixed FiberTape® suture with swedged suture tails for simplified suture passing and the option of a tensionable knotless mechanism or sliding SutureTape.

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video

FiberTak® SpeedBridge™ Repair

Patrick J. Denard, MD (Medford, OR), demonstrates how to use 2.6 FiberTak® RC anchors and 4.75 mm SwiveLock® anchors to complete a knotless double-row FiberTak SpeedBridge rotator cuff repair.

FiberTak® SpeedBridge™ Rotator Cuff Repair

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FiberTak SpeedBridge™ Rotator Cuff Repair ® Surgical Technique FiberTak® SpeedBridge™ Repair As the next evolution of knotless rotator cuff repair, the FiberTak SpeedBridge technique is completed with 2.6 FiberTak RC soft anchors on the medial row and FiberTape® sutures fixated laterally with trusted SwiveLock® anchors. This knotless repair creates a quick, secure construct in as few as three suturepassing steps. The small size of the 2.6 FiberTak RC anchors allows for three points of medial-row fixation where previously only two fixation points could be achieved. Advantages Biomechanical repair strength is comparable to traditional SpeedBridge repair1 Multiple fixation points and additional FiberTape sutures increase tendon-to-bone compression Contact area of the tendon-to-footprint interface increased 14% compared to traditional hard-bodied anchors2 Secure lateral fixation with trusted SwiveLock® anchors Enhancements Knotless 2.6 FiberTak RC anchors are adaptable and can conform to traditional repair techniques while providing the additional benefits of tensionable knotless technology for incorporating biologics or increasing medial-row compression. Double-Pulley Ripstop With ArthroFLEX® Dermal Allograft Augmentation Canopy Augmentation With ArthroFLEX Dermal Allograft Independent Mattress Ripstops Independent Mattress Stitches ArthroFLEX is a registered trademark of LifeNet Health. 02 I FiberTak® SpeedBridge™ 2.6 FiberTak® RC Soft Anchors These anchors are available with fixed 1.7 mm FiberTape® suture—with joined tails for simplified suture-passing— and the option of a sliding SutureTape or tensionable knotless mechanism. 2.6 FiberTak RC Soft Anchors Knotless 2.6 FiberTak RC Soft Anchors Sliding 1.3 SutureTape Incorporate sliding SutureTape for knotted medial-row compression variations or remove if it is not needed for the repair. Tensionable Knotless Mechanism With the tensionable knotless mechanism, complete a variety of medial-row compression variations and easily incorporate biologics. Self-Punching Inserters All 2.6 FiberTak anchors are loaded on self-punching inserters, which eliminate the need to predrill or prepunch a socket for anchor insertion, reducing surgical steps. Use these inserters with or without a guide; drills and punches are available for hard bone. SwiveLock® Lateral-Row Anchors Trusted fixation with more than 10 million anchors used since 2006 Joined FiberTape® Suture Tails Simplified suture-passing Shuttle both limbs of FiberTape suture with one pass Available with #2 suture for tensionable knotless dogear or cable fixation FiberTak® SpeedBridge™ I 03 FiberTak SpeedBridge™ Technique: Medial Row ® 04 I FiberTak® SpeedBridge™ Technique: Medial Row FiberTak® SpeedBridge™ Technique: Medial Row 1 While viewing through a posterolateral portal, prepare the rotator cuff footprint and identify the posteromedial anchor insertion point. Using a mallet, insert and advance the 2.6 FiberTak RC anchor into bone; stop at the insertion zone laser line. If hard bone is encountered, use a punch or drill to create a socket to ease anchor insertion. 3 Load the single end of FiberTape® suture onto a Scorpion™ suture passer and advance through the rotator cuff. Pull the suture to smoothly lead both FiberTape suture limbs through the tissue. 2 Once the anchor is fully inserted, remove the suture retention ring and inserter. Grasp all limbs of the suture and pull slowly to set the anchor. Repeat steps 1 and 2 for middle and anterior medial-row anchors. Once the anchors are inserted, remove the sliding SutureTape. 4 Cut off the joined suture tail, allowing each suture limb to be separated for lateral fixation. Tension each suture limb independently to remove any potential slack beneath the tendon. FiberTak® SpeedBridge™ Technique: Medial Row I 05 FiberTak SpeedBridge™ Technique: Lateral Row ® 06 I FiberTak® SpeedBridge™ Technique: Lateral Row FiberTak® SpeedBridge™ Technique: Lateral Row 1 2 Retrieve one FiberTape® suture tail from each medial anchor and preload them through the SwiveLock® anchor eyelet. Using a punch, prepare a bone socket about 5 mm–10 mm lateral to the edge of the tuberosity. Bring the eyelet of the implant to the edge of the bone socket and remove slack from each suture to reduce the tissue and compress it to the bone. Note: Use a hemostat to secure sutures in place while preparing a bone socket. 3 Completely advance the driver into the bone socket, beyond the first laser line and until the anchor body contacts bone. Evaluate suture tension. If tension is not adequate, back the driver out and readjust the tension. 4 5 Make sure the tip of the anchor body is in contact with bone. Hold the thumb pad steady and rotate the driver handle in a clockwise direction to insert the anchor body until it is flush with the bone. Cut the FiberTape suture tails with a FiberTape cutter. Repeat these steps for the second lateral anchor. Note: Do not attempt to apply tension to the sutures with the eyelet in the bone socket. FiberTak® SpeedBridge™ Technique: Lateral Row I 07 FiberTak SpeedBridge™ Technique: Knotless Double-Pulley Ripstop ® 08 I FiberTak® SpeedBridge™ Technique: Knotless Double-Pulley Ripstop FiberTak® SpeedBridge™ Technique: Knotless Double-Pulley Ripstop Tendon reduction under direct visualization and tensionable knotless medial fixation can be achieved with the knotless double-pulley. Shuttle the tensionable knotless sutures through the cuff with a separate pass to help prevent the construct from twisting beneath the rotator cuff. 1 2 Once the FiberTape® sutures are passed, use a FiberLink™ shuttle suture to pass the knotless sutures. Using the Scorpion™ suture passer, load the single end of a FiberLink suture and pass it lateral and outside of the anterior and posterior 2.6 FiberTak RC anchors to form the double-pulley ripstop. Retrieve the tail of the FiberLink suture from a superior portal to improve the shuttling angle through the tissue. Retrieve the sutures of the knotless mechanism, load them into the loop of the FiberLink shuttle suture, and pass the FiberLink suture through the rotator cuff. Repeat the same steps for the posterior anchor. Note: For this technique, cut out the middle anchor’s knotless mechanism; the tensionable knotless mechanisms of the anterior and posterior anchors will be linked together in steps 4 and 5. (d) (c) (b) (a) (g) (f) (e) 3 Posterior Anchor Middle Anchor Anterior Anchor a. TigerLink™ shuttle stitch d. 1 .7 mm FiberTape sutures e. FiberLink shuttle stitch b. Blue repair stitch f. Blue/black repair stitch c. 1.7 mm TigerTape™ sutures g. 1.7 mm black FiberTape sutures FiberTak® SpeedBridge™ Technique: Knotless Double-Pulley Ripstop I 09 (b) (e) 4 Retrieve the posterior blue repair suture (b) and the anterior looped end of the white/blue shuttle suture (e) from the lateral cannula. Feed the end of the repair suture through the shuttle suture loop and fold it at the ink-mark indicator. Pull the tape suture tail of the white/blue shuttle suture (e) to shuttle the repair suture into the knotless mechanism. Note: Tension the repair suture, but do not tighten it completely until the second repair suture is shuttled. (a) (f) 5 Repeat the previous steps using the anterior blue/black repair suture (f) and the posterior looped end of the white/ black shuttle suture. (a) 10 I FiberTak® SpeedBridge™ Technique: Knotless Double-Pulley Ripstop 6 Tension the two repair sutures, reducing and fixating the tendon to the bone. Tension the FiberTape® suture limbs independently to remove any potential slack beneath the tendon. Cut the repair sutures flush once adequate fixation is achieved. Note: Refer back to the lateral-row fixation technique to complete repair. FiberTak® SpeedBridge™ Technique: Knotless Double-Pulley Ripstop I 11 FiberTak SpeedBridge™ Technique: Dog-Ear or Cable Fixation ® 12 I FiberTak® SpeedBridge™ Technique: Dog-Ear or Cable Fixation FiberTak® SpeedBridge™ Technique: Dog-Ear Reduction Suture Achieve anterior and posterior lateral tissue fixation with the repair stitches from Knotless SwiveLock® anchors. 1 Retrieve the knotless sutures from the lateral cannula. Load the blue repair suture onto a Scorpion™ suture passer and advance through tissue. 3 Tension the repair suture, reducing and fixating the tendon to the bone. A suture cutter can be used to hold the anchor steady during tensioning. Cut the repair suture once adequate fixation is achieved. 2 Feed the end of the repair suture through the shuttle suture loop and fold it at the ink-mark indicator. Pull the tape shuttle suture tail to shuttle the repair suture into the tensionable knotless mechanism. 4 Double-Pulley Ripstop With Dog-Ear or Cable Fixation Note: If using Knotless SwiveLock anchors and additional lateral fixation is not required, pull one end of the shuttle stitch to remove and cut the repair stitch and FiberTape® sutures with a FiberTape suture cutter. FiberTak® SpeedBridge™ Technique: Dog-Ear or Cable Fixation I 13 Ordering Information 2.6 FiberTak® RC Anchors Product Description Item Number 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm TigerTape™ loop (white/black), 1.3 mm SutureTape (white/blue) AR-3652SP 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm FiberTape® loop (blue), 1.3mm SutureTape (white/black) AR-3652TSP 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm FiberTape loop (black/blue), 1.3 mm SutureTape (blue/blue) AR-3652TTSP Knotless 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm TigerTape loop (white/black) and #2 Suture (blue) AR-3653SP Knotless 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm FiberTape loop (blue) and #2 Suture (white/back) AR-3653TSP Knotless 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm FiberTape loop (black/blue), #2 Suture (blue/black) AR-3653TTSP SwiveLock® Anchors Product Description Item Number Knotless BioComposite SwiveLock Anchor, 4.75 mm × 19.1 mm w/ #2 suture (Blue) and SutureTape link (white/blue) AR-2324KBCC Knotless BioComposite SwiveLock Anchor, 5.5 mm × 19.1 mm w/ #2 suture (Blue) and SutureTape link (white/blue) AR-2323KBCC Knotless PEEK SwiveLock Anchor, 4.75 mm × 19.1 mm w/ #2 suture (Blue) and SutureTape link (white/blue) AR-2324KPSLC Knotless PEEK SwiveLock Anchor, 5.5 mm × 19.1 mm w/ #2 suture (Blue) and SutureTape link (white/blue) AR-2323KPSLC BioComposite SwiveLock C Anchor, 4.75 mm × 19.1 mm AR-2324BCC BioComposite SwiveLock C Anchor, 5.5 mm × 19.1 mm AR-2323BCC PEEK SwiveLock C Anchor, 4.75 mm × 19.1 mm AR-2324PSLC PEEK SwiveLock C Anchor, 5.5 mm × 19.1 mm AR-2323PSLC Instruments Product Description Item Number Disposables Kit for 2.6 FiberTak Anchors AR-3650DS Includes: spear, trocar-tip obturator, and 2.6 mm drill Angled Spear w/ Circumferential Teeth for 2.6 FiberTak and RC Anchors AR-3655 Punch for 2.6 FiberTak and RC Anchors, reusable AR-3656 Drill for 2.6 FiberTak and RC Anchors, reusable AR-3657 Blunt Obturator for 2.6 FiberTak and RC Anchor Spear, reusable AR-3658B Sharp Obturator for 2.6 FiberTak and RC Anchor Spear, reusable AR-3658T Circumferential Teeth Spear AR-1941CT Fishmouth Spear AR-1941DGF Punch for 5.5 mm Corkscrew® FT and 4.75 mm and 5.5 mm SwiveLock Anchors AR-1927PB Disposable Punch for 5.5 mm Corkscrew FT and 4.75 and 5.5 mm SwiveLock Anchors AR-1927PBS FastPass Scorpion™ SL Suture Passer AR-13999MF FiberTape Suture Cutter AR-13250 FiberTape Retriever, w/ self-ratcheting handle AR-13974SR Suture Cutter, 4.2 mm, straight AR-12250 14 I FiberTak® SpeedBridge™ Rotator Cuff Repair References 1. Arthrex, Inc. Data on file (APT-05242). Naples, FL; 2021. 2. Arthrex, Inc. Data on file (APT-05350). Naples, FL; 2021. FiberTak® SpeedBridge™ Rotator Cuff Repair I 15 This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience, and should conduct a thorough review of pertinent medical literature and the product’s directions for use. Postoperative management is patient-specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level and/or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking arthrex.com © 2022 Arthrex, Inc. All rights reserved. LT1-000204-en-US_A

Rotator Cuff Repair With ® FiberTak Soft Anchors FiberTak® Soft Anchor for Rotator Cuff Repair Rotator cuff repair requires versatile anchors that can meet the demands of different repair constructs. The family of 2.6 FiberTak soft anchors offers options for all types of rotator cuff repairs. With a smaller anchor size compared to traditional hard-bodied anchors, more points of fixation can be achieved in the footprint of the rotator cuff. With different suture configurations like SutureTape, tensionable knotless technology, and 1.7 mm FiberTape® suture, you have multiple options for various rotator cuff repairs. 2.6 FiberTak Soft Anchor Enhance single- and double-row knotted rotator cuff repairs with the double- or triple-loaded 2.6 FiberTak anchors, which are loaded with 1.3 SutureTape allowing for stronger knots and smaller knotstacks than #2 suture. Knotless 2.6 FiberTak Soft Anchor Tensionable knotless technology with a #5 suture eliminates the need to tie knots and allows for reproducible results for procedures such as upper border subscapularis repair, PASTA, and remplissage. 2.6 FiberTak RC Soft Anchor Double-row rotator cuff repair using the FiberTak SpeedBridge™ technique features 2.6 FiberTak RC anchors with 1.7 mm FiberTape® suture on the medial row for a completely knotless repair. Self-Punching Inserters All 2.6 FiberTak anchors are loaded on self-punching inserters, which eliminates the need to predrill or prepunch a socket for anchor insertion and reduces surgical steps. These inserters can be used with or without a guide. Insertion zone Transtendon insertion reference Insertion zone 02 I Rotator Cuff Repair With FiberTak® Soft Anchors 2.6 FiberTak® Soft Anchor The 2.6 FiberTak soft anchor offers the ability to create both single- and double-row repairs. Available in double- and triple-loaded self-punching options, these anchors leverage the latest innovation in suture technology with SutureTape, which is a flat-braided #2 suture. SutureTape feels flat-out better than round suture and offers: Increased resistance to tissue pull-through Tighter, smaller knot stacks Better handing characteristics Load at 3 mm Displacement (lbf) Pullout Strength With Surgeon‘s Knot1 2.6 FiberTak suture anchor double-loaded with SutureTape 70 60 50 40 30 20 10 1.3 mm SutureTape SutureBridge™ medial-row repair with triple-loaded 2.6 FiberTak anchor #2 Suture Single-row repair with triple-loaded 2.6 FiberTak anchor 2.6 FiberTak soft anchor triple-loaded with SutureTape Rotator Cuff Repair With FiberTak® Soft Anchors I 03 Knotless 2.6 FiberTak® Soft Anchor The Knotless 2.6 FiberTak soft anchor features a #5 repair suture and tensionable knotless technology optimized for upper border subscapularis, PASTA, and remplissage procedures. #5 Repair Suture Achieve broad soft-tissue compression with this #5 suture in a knotless construct. A proprietary process smoothly tapers the end of the suture to a size 0 suture while maintaining the integrity of the braid. This suture is ideal for passing with a Scorpion™ suture passer. Self-punching 2.6 Knotless FiberTak anchor w/ #5 suture Tensionable Knotless Technology This unique technology can be used in multiple configurations such as a simple or mattress stitch, or interconnected with another Knotless 2.6 FiberTak anchor. Control tension under direct visualization with the tensionable suture-locking mechanism and reproducibly create fully knotless constructs without compromising fixation strength or integrity compared to knotted constructs. Simple Stitch Mattress Stitch Knotless Upper-Border Subscapularis Repair 2.6 Knotless FiberTak anchor with completed knotless mechanism 04 I Rotator Cuff Repair With FiberTak® Soft Anchors 2.6 FiberTak® RC Soft Anchor The 2.6 FiberTak RC anchor is designed specifically for the medial row of a FiberTak SpeedBridge™ rotator cuff repair, which includes secure lateral fixation with trusted Knotless SwiveLock® anchors. These anchors feature fixed FiberTape® suture with the option of an additional tensionable knotless mechanism or sliding SutureTape. Biomechanics of FiberTak SpeedBridge Repair FiberTak SpeedBridge repair has been shown to produce similar biomechanical results compared to traditional SpeedBridge repair.2 1.7 mm FiberTape Suture Smaller width and lower profile option Tape portion smoothly transitions to size 0 joined tails for simplified suture-passing 2.6 FiberTak RC anchors Joined FiberTape suture tails Anchor Options Sliding SutureTape Sliding SutureTape, which can be incorporated into the repair or discarded, comes with the 2.6 FiberTak RC anchor Tensionable Knotless Mechanism With the tensionable knotless mechanism, complete various medial-row compression configurations and easily incorporate biologics Knotless 2.6 FiberTak RC anchors Biologic Incorporation Medial Compression Rotator Cuff Repair With FiberTak® Soft Anchors I 05 Ordering Information Implants 2.6 FiberTak® Soft Anchor Product Description Item Number Self-Punching 2.6 FiberTak Soft Anchor, double-loaded AR-3632SP Self-Punching 2.6 FiberTak Soft Anchor, triple-loaded AR-3633SP Knotless 2.6 FiberTak Soft Anchor Product Description Item Number Self-Punching Knotless 2.6 FiberTak Soft Anchor w/ #5 Suture AR-3641SP 2.6 FiberTak RC Soft Anchors Product Description Item Number 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm TigerTape™ Loop (white/black), 1.3 mm SutureTape (white/blue) AR-3652SP 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm FiberTape® Loop (blue), 1.3 mm SutureTape (white/black) AR-3652TSP 2.6 FiberTak RC Soft Anchor, self-punching, 1.7 mm FiberTape Loop (black/blue), 1.3 mm SutureTape (blue/blue) AR-3652TTSP Knotless 2.6 FiberTak Soft Anchor, self-punching, 1.7 mm TigerTape Loop (white/black), #2 suture (blue) AR-3653SP Knotless 2.6 FiberTak Soft Anchor, self-punching, 1.7 mm FiberTape Loop (blue), #2 suture (white/black) AR-3653TSP Knotless 2.6 FiberTak Soft Anchor, self-punching, 1.7 mm FiberTape Loop (black/blue), #2 suture (blue/black) AR-3653TTSP Lateral-Row SwiveLock® Anchors Product Description Item Number Knotless BioComposite SwiveLock® Anchor, 4.75 mm × 19.1 mm w/ #2 suture (blue) and SutureTape Link (white/blue) AR-2324KBCC Knotless BioComposite SwiveLock Anchor, 5.5 mm × 19.1 mm w/ #2 suture (blue) and SutureTape Link (white/blue) AR-2323KBCC Knotless PEEK SwiveLock Anchor, 4.75 mm × 19.1 mm w/ #2 suture (blue) and SutureTape Link (white/blue) AR-2324KPSLC Knotless PEEK SwiveLock Anchor, 5.5 mm × 19.1 mm w/ #2 suture (blue) and SutureTape Link (white/blue) AR-2323KPSLC BioComposite SwiveLock C Anchor, 4.75 mm × 19.1 mm AR-2324BCC BioComposite SwiveLock C Anchor, 5.5 mm × 19.1 mm AR-2323BCC PEEK SwiveLock C Anchor, 4.75 mm × 19.1 mm AR-2324PSLC PEEK SwiveLock C Anchor, 5.5 mm × 19.1 mm AR-2323PSLC 06 I Rotator Cuff Repair With FiberTak® Soft Anchors Instruments Disposable Instruments Product Description Item Number Disposables Kit for 2.6 FiberTak® Soft Anchor (includes 2.6 FiberTak spear, trocar-tip obturator, and 2.6 mm drill) AR-3650DS Disposable Punch for 5.5 mm Corkscrew® FT and 4.75 mm and 5.5 mm SwiveLock® Anchors AR-1927PBS Reusable Instruments Product Description Item Number Angled Spear w/ Circumferential Teeth for 2.6 FiberTak and DR Anchors AR-3655 Punch for 2.6 FiberTak Anchors, reusable AR-3656 Drill for 2.6 FiberTak Anchors, reusable AR-3657 Blunt Obturator for 2.6 FiberTak Anchor Spear, reusable AR-3658B Sharp Obturator for 2.6 FiberTak Anchor Spear, reusable AR-3658T Spear w/ Circumferential Teeth, trocar-tip obturator, reusable AR-1906 Fishmouth Spear, trocar-tip obturator, reusable AR-1907 Punch for 5.5 mm Corkscrew FT and 4.75 mm and 5.5 mm SwiveLock Anchors AR-1927PB Disposable Punch for 5.5 mm Corkscrew FT and 4.75 and 5.5 mm SwiveLock Anchors AR-1927PBS FastPass Scorpion™ SL Suture Passer AR-13999MF FiberTak® Suture Cutter AR-13250 FiberTape Retriever, w/ self-ratcheting handle AR-13974SR Circumferential Teeth Guide for for 2.6 FiberTak and 3.9mm Knotless Corkscrew Anchor AR-1941CT Fishmouth Guide for for 2.6 FiberTak and 3.9mm Knotless Corkscrew Anchor AR-1941DGF AR-3655 AR-1906 AR-1907 AR-3658T AR-3658B AR-3656 AR-3657 Angled Spear w/ Circumferential Teeth Spear w/ Circumferential Teeth Fishmouth Spear Trocar-Tip Obturator Blunt-Tip Obturator Punch for 2.6 FiberTak Soft Anchors Drill for 2.6 FiberTak Soft Anchors Rotator Cuff Repair With FiberTak® Soft Anchors I 07 View U.S. Patent information at www.arthrex.com/corporate/virtual-patent-marking References 1. Arthrex Inc. LA1-00038-EN. Naples, FL. 2021. 2. Arthrex, Inc. Data on file (APT-05242). Naples, FL; 2021. This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience, and should conduct a thorough review of pertinent medical literature and the product’s directions for use. Postoperative management is patient-specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level and/or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking arthrex.com © 2022 Arthrex, Inc. All rights reserved. LB1-00105-EN_B

Rotator Cuff Repair with FiberTak® Soft Anchors

Child (D)

Product

The partially threaded Knotless Corkscrew anchor provides knotless soft-tissue fixation and has a tensionable suture-locking mechanism. Suture is passed and shuttled into the locking mechanism, allowing users to control the tension of knotless repairs. These anchors can be used for PASTA, remplissage, upper subscapularis, and SCR repairs.

Remplissage for Anterior Instability Scientific Update Remplissage, which is used in combination with arthroscopic Bankart repair, addresses anterior instability associated with bone loss. Biomechanical studies indicate that insetting the posterior capsule and tendon into a Hill-Sachs defect improves joint stability. With recent innovations in knotless products and techniques, the addition of remplissage is more reproducible and efficient. A knotless technique—with two tensionable, knotless anchors and interconnected repair sutures—creates a reliably strong repair that minimizes the risk of knot impingement and migration. Clinical studies have consistently demonstrated that the addition of remplissage reduces recurrence rates, with minimal change to range of motion, compared to an isolated arthroscopic Bankart repair. When compared to Latarjet, remplissage appears to equally prevent recurrence but with a lower complication rate. Foundations Di Giacomo G, Itoi E, Burkhart SS Evolving concept of bipolar bone loss and the Hill-Sachs lesion: from “engaging/nonengaging” lesion to “on-track/off-track” lesion. Arthroscopy. 2014;30(1):90-98. doi:10.1016/j. arthro.2013.10.004 Reviews the impact of bipolar bone loss in anterior instability and treatment recommendations In abduction and external rotation, the contact zone of the humeral head with the glenoid—termed the glenoid track—is approximately 83% of the glenoid width Reduced both by glenoid bone loss and a Hill-Sachs lesion Calculate the width of the glenoid track with the following formula: 0.83D (normal glenoid diameter) − d (glenoid bone loss) Measure the width of the Hill-Sachs lesion to determine if the lesion is “on-track” (within the remaining glenoid track) or “off-track” (exceeds the remaining glenoid track) Authors recommend adding remplissage to off-track lesions with <25% glenoid bone loss Takeaways The normal glenohumeral joint has a glenoid track of 83% of the glenoid width in abduction and external rotation, which is reduced with glenoid bone loss or a Hill-Sachs lesion These concepts provide a paradigm of treatment for the average population but should be taken in the context of the individual patient (ie, an individual with laxity will have a reduced glenoid track due to increased likelihood of anterior subluxation while a low-demand, stiffer patient will have a lower likelihood) Shaha JS, Cook JB, Rowles DJ, Bottoni CR, Clinical validation of the glenoid track concept in anterior glenohumeral instability. J Bone Joint Surg Am. 2016;98(22):1918-1923. doi:10.2106/JBJS.15.01099 Retrospective study of 57 patients who underwent Bankart repair were evaluated at a mean follow-up of 48 months Hill-Sachs lesions were categorized as on-track or off-track based on MRI evaluation Recurrence was 8% in the on-track group compared to 75% in the off-track group (P = .0001) Shaha SH, Tokish JM Takeaway Patients with off-track Hill-Sachs lesions have a high risk of recurrence with isolated Bankart repair Biomechanical Studies Arciero RA, Parrino A, Bernhardson AS, et al The effect of a combined glenoid and Hill-Sachs defect on glenohumeral stability: a biomechanical cadaveric study using 3-dimensional modeling of 142 patients. Am J Sports Med. 2015;43(6):1422-1429. doi:10.1177/0363546515574677 Hill-Sachs lesions were created in 21 cadaveric shoulders based on modeling from CT scans in 142 patients with recurrent anterior instability Anterior translation was examined before and after Bankart repair in models with small and medium Hill-Sachs lesions with the following glenoid bone loss: Intact glenoid 2 mm bone loss (approximately 8% glenoid bone loss) 4 mm bone loss (approximately 15% glenoid bone loss) 6 mm bone loss (approximately 23% glenoid bone loss) Results showed that anterior translation persisted after isolated Bankart repair: With an 8% glenoid defect and a medium Hill-Sachs lesion With a 15% glenoid defect and a small Hill-Sachs lesion Takeaways Stability after bone loss is related to the combined effects of glenoid bone loss and the size of the Hill-Sachs lesion Isolated Bankart repairs may be compromised with as little as 2 mm to 4 mm of bone loss, or 8% to 15% of the glenoid width Hartzler RU, Bui CN, Jeong WK, et al Remplissage of an off-track Hill-Sachs lesion is necessary to restore biomechanical glenohumeral joint stability in a bipolar bone loss model. Arthroscopy. 2016;32(12):24662476. doi:10.1016/j.arthro.2016.04.030 8 cadaveric shoulders were placed in a custom apparatus to evaluate passive axial rotation followed by progressive translational loading A 15% glenoid bone loss model was used to evaluate on-track (15%) and off-track (30%) HillSachs lesions Repair conditions included isolated Bankart repair and Bankart combined with remplissage Results showed that engagement occurred: With 1 on-track lesion, which was prevented with isolated Bankart repair alone With all 8 off-track lesions, which was only prevented in mid-range rotation with isolated Bankart repair; prevention of engagement at end-range rotation was prevented in all specimens with the addition of remplissage Takeaways Funakoshi T, Hartzler R, Stewien E, Burkhart S Isolated Bankart alone results in persistent engagement of an off-track lesion in a bipolar bone loss model “Remplissage was necessary to prevent engagement of off-track bipolar lesions” Remplissage using interconnected knotless anchors: superior biomechanical properties to a knotted technique? Arthroscopy. 2018;34(11):2954-2959. doi:10.1016/j.arthro.2018.06.030 Cadaveric study of remplissage with 2 different techniques: Knotted technique with 2 anchors Knotless technique with sutures interconnected between the anchors (3.9 mm Knotless Corkscrew® anchors) Load to failure was higher with the knotless technique (788 N vs 488 N; P = .003) Most common mode of failure for the knotted technique was tendon tearing or knot failure No failures in the knotless group occurred via suture slippage Takeaways Constructs interconnecting knotless repair sutures between 2 anchors are superior to knotted techniques The knotless construct evaluated in this study can be reproduced with other anchors containing the same mechanism, including Knotless FiberTak® (1.8 mm or 2.6 mm) and 3.0 mm Knotless SutureTak® anchors Clinical Studies Garcia GH, Wu HH, Liu JN, Huffman GR, Outcomes of the remplissage procedure and its effects on return to sports: average 5-year follow-up. Am J Sports Med. 2016;44(5):1124-1130. doi:10.1177/0363546515626199 Retrospective review of 51 combined Bankart and remplissage repairs with large, off-track lesions and <20% glenoid bone loss Functional outcome and recurrence were reviewed at a mean of 5 years postoperative Six shoulders had dislocation events (11.8%) postoperatively Average loss of external rotation was 5° Rate of return to sport was 95.5% Kelly JD 4th Of those engaged in throwing, difficulty doing so was reported by 65.5% Takeaways Domos P, Ascione F, Wallace AL High return to sport with minimal loss in range of motion and low chance of recurrence with addition of remplissage Throwing difficulty is common after remplissage, but should be examined in the context that throwing difficulty is common in the setting of bipolar bone loss Arthroscopic Bankart repair with remplissage for non-engaging Hill-Sachs lesion in professional collision athletes. Shoulder Elbow. 2019;11(1):17-25. doi:10.1177/1758573217728414 Retrospective review of contact athletes with anterior instability and <20% glenoid bone loss evaluated at a mean follow-up of 26 months 20 athletes were treated with combined Bankart and remplissage Matched group was treated isolated Bankart There was no difference in postoperative range of motion Recurrence was 5% in the remplissage group compared to 30% in the isolated Bankart group (P = .015) Takeaway Recurrence in contact athletes is reduced with the addition of remplissage Haroun HK, Sobhy MH, Abdelrahman AA Arthroscopic Bankart repair with remplissage versus Latarjet procedure for management of engaging Hill-Sachs lesions with subcritical glenoid bone loss in traumatic anterior shoulder instability: a systematic review and meta-analysis. J Shoulder Elbow Surg. 2020;29(10):21632174. doi:10.1016/j.jse.2020.04.032 Systematic review of 379 patients (from 4 studies) who underwent combined Bankart with remplissage or Latarjet for <20% glenoid bone loss 194 Bankart and remplissage procedures 185 Latarjet procedures There was no difference in postoperative range of motion, functional outcome scores, or recurrence between remplissage and Latarjet groups (9.8% vs 7%) Risk of complication was 7 times higher in the Latarjet group (9% vs 1%; P = .003) Takeaway Hurley ET, Toale JP, Davey MS, et al Remplissage and Latarjet results in comparable rates of recurrence for subcritical bone loss, but complications are higher with Latarjet Remplissage for anterior shoulder instability with Hill-Sachs lesions: a systematic review and meta-analysis. J Shoulder Elbow Surg. 2020;29(12):2487-2494. doi:10.1016/j.jse.2020.06.021 Literature review of 12 clinical trials comparing arthroscopic Bankart repair and remplissage vs arthroscopic Bankart repair alone or the Latarjet procedure performed in patients with anterior shoulder instability with Hill-Sachs lesions Statistical results Remplissage plus Bankart repair had a significantly lower recurrence rate compared to Bankart alone (3.2% vs 16.8% P < .05) Complication rate was significantly lower for remplissage plus Bankart procedures compared to Latarjet procedures (0.5% vs 8.6% P = .003) No significant difference in revision rate of Bankart alone Compared to Latarjet procedures, no significant difference in recurrence rate, revision rate, or revision due to recurrence rate Takeaway Patients with subcritical glenoid bone loss have a lower risk for recurrance with remplissage with arthroscopic Bankart repair compared to Bankart repair alone. Latarjet has comparable rates of recurrence and revision but the risk of complications is significantly higher. Supporting Literature Shaha JS, Cook JB, Song DJ, et al. Redefining “critical” bone loss in shoulder instability: functional outcomes worsen with “subcritical” bone loss. Am J Sports Med. 2015;43(7):1719-1725. doi:10.1177/0363546515578250 arthrex.com © 2021 Arthrex, Inc. All rights reserved. DOC1-000498-en-US_A

Remplissage for Anterior Instability Scientific Update

Arthrex® Bio and Biocomposite Implants: Post-op Complaint Analysis by Product Family

Fixation Strength for PEEK Knotless Corkscrew® Suture Anchor versus Knotted PEEK SutureTak® Suture Anchor Arthrex Research and Development Objective: Anterior shoulder instability associated with mild glenoid bone loss and a large Hill-Sachs lesion is a well-known skeletal pathology of the shoulder[1]. Numerous operations have been used to address bone loss, and among these, arthroscopic Remplissage is one of the options with good long-term results reported in the literature[2]. Briefly, this procedure aims to convert a bony intra- articular defect into an extra-articular defect by insetting the infraspinatus into the Hill-Sachs lesion. The purpose of this study was to investigate fixation strength and gap formation of 2 different Remplissage fixation methods, namely, knotted medial pulley and knotless medial pulley in cadaveric shoulders and foam blocks. Materials & Methods: Cadaveric Study: Seven matched pair cadaveric shoulders (age ≤ 65 years) were used. Each side randomly received either a knotted (PEEK 3.0 mm SutureTak® Anchor, AR-1934PS, Arthrex, Inc.) or knotless (PEEK 3.9 mm Knotless Corkscrew® Anchor, AR-1941PS, Arthrex, Inc.) construct using the surgical technique mentioned by Koo, et al. (Figures 1A and 1B). Post-Remplissage, biomechanical testing was conducted. The humerus was clamped in 60º and 15º of external rotation with respect to anatomic configuration and musculotendinous junction of infraspinatus was cryoclamped (Figure 1C). Specimens were cyclically loaded between 10N-100N with 1Hz frequency followed by pull to failure at 33 mm/s. Load at 5 mm displacement was recorded as 5 mm and was considered a clinical failure. Figure 1: (A and B) Shows surgical repair using Remplissage technique. (C) Shows biomechanical test setup. Foam Block Study: Ten 30 lf/ft cubed foam blocks, 5 for knotted suture anchor and 5 for knotless suture anchor, were prepared by creating a “trench” in the center to accommodate hook and drilling 2 pilot holes 20 mm apart using same instrumentation (drill, spear, mallet, etc) used for cadaveric study. Using box fixture and hook, mechanical test was performed using same loading protocol as cadaveric study (Figure 2). Ultimate load and cyclic displacement was recorded. Figure 2: (A) Shows experimental set up for knotted suture anchor. (B) Shows experimental setup for knotless suture anchor. Results: Cadaveric Study: Before clinical failure (5 mm displacement), the knotless suture anchor achieved higher loads and there was a statistically significant difference in load between the 2 groups (P = 0.015) (Figure 3). Foam Block Study: The knotless suture anchor achieved higher ultimate load as compared to the knotted suture anchor and there was a statistically significant difference in ultimate load between the 2 groups (P = 0.006) (Figure 4). There was no statistically significant difference in cyclic displacement between the 2 groups (P = 0.059) (Figure 5). NOTE: See charts on second page. Conclusion: The PEEK 3.9 mm knotless Corkscrew® anchors performed better and provide a mechanically superior repair when compared to the knotted PEEK SutureTak® anchors. © 2017 Arthrex, Inc. All rights reserved. LA1-00066-EN_A L oa d at 5 m m D is pl ac em en t (N ) 1000 900 800 700 600 500 400 300 200 100 0 Knotless Knotted P = 0.015 U lt im at e L oa d (N ) 450 400 350 300 250 200 150 100 50 0 Knotless Knotted P = 0.006 C yc lic D is pl ac em en t (m m ) 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 Knotless Knotted P = 0.059 Figure 3: Load at 5 mm displacement for cadaveric study Figure 5: Cyclic displacement for foam block study Figure 4: Ultimate load for foam block study References: 1. Koo SS, Burkhart SS, Ochoa E. Arthroscopic double-pulley remplissage technique for engaging Hill-Sachs lesions in anterior shoulder instability repairs. Arthroscopy. 2009;25(11):1343-1348. doi:10.1016/j.arthro.2009.06.011. 2. Hartzler RU, Bui CN, Jeong WK, et al. Remplissage of an off-track Hill-Sachs lesion is necessary to restore biomechanical glenohumeral joint stability in a bipolar bone loss model. Arthroscopy. 2016;32(12):2466-2476. doi:10.1016/j. arthro.2016.04.030.

Fixation Strength for PEEK Knotless Corkscrew® Suture Anchor versus Knotted PEEK SutureTak® Suture Anchor

Knotless Corkscrew® Anchor

2.6 FiberTak RC anchors are specifically designed for surgeons who prefer an all-suture anchor for the medial row of a double-row, bridging rotator cuff repair. They are combined with knotless SwiveLock® C anchors for the lateral row. The unique 2.6 FiberTak RC anchor has a 1.7 FiberTape® suture fixed to the sheath so that it cannot slide, making it easy to tension the lateral row for a totally knotless construct. The 2.6 FiberTak RC anchor is available with a tensionable knotless mechanism or a sliding 1.3 mm SutureTape that can be incorporated into the repair, or discarded, for ultimate flexibility.
The self-punching inserter for select FiberTak anchors allows for direct insertion into bone without creating a prepunched or predrilled socket for anchor insertion. The self-punching FiberTak inserter may be used with or without a guide and can be placed directly into bone or used with a transtendon insertion technique.

2.6 FiberTak® RC Soft Anchors

The PASTA bridge technique allows for the transtendon repair of partial, articular-sided supraspinatus tendon avulsions. This technique simplifies PASTA repair, while providing a secure bridging technique that enhances footprint compression to maximize contact between tendon and bone.
The technique can be performed in a knotted or knotless fashion through percutaneous transtendon anchor insertion with no arthroscopic suture passing or knot tying, creating a simple, reproducible technique.

900 800 700 600 500 400 100 200 300 0 p < 0.001 U lti m at e Lo ad (N ) SutureTak® Double Pulley Interconnected Knotless SutureTak® Interconnected Knotless SutureTak® and SutureTak® Anchor Pulley Construct Objective: Arthrex, Inc., Research and Development Determine the mechanical strength of a novel Interconnected 3.0 mm PEEK Knotless SutureTak® construct and compare the results to those of a traditional knotted 3.0 PEEK SutureTak Double Pulley construct, as could be used for a transtendon PASTA or Remplissage technique. Methods and Materials: Twelve 30 lf/ft3 foam blocks were prepared by drilling two pilot holes using the AR-1250LT drill and AR-1949 spear, 20 mm apart. Either two 3.0 mm PEEK Knotless SutureTak® (AR-1938PS) or two 3.0 mm PEEK SutureTak (AR-1934PS) were inserted into the pilot holes using a mallet. Nylon straps were doubled over and the sutures were shuttled through both layers of the material, approximately 15 mm from the ends of the strap. The Interconnected Knotless SutureTak construct was created by pulling the suture tails through the opposite anchor’s splice. Double Pulley constructs were created by tying 6-throw surgeon’s knots. Mechanical testing was performed using an E10000 Electropulse INSTRON Materials Testing System with a 10 kN load cell. A vise and metal plate fixture secured the foam block to the testing surface, such that the direction of pull would be perpendicular to the suture anchor long axis. The looped nylon strap was connected to the cross-head with a clevis and dowel fixture, as shown in Figures 1 and 2. Samples were cycled between 0 and 100 N for 100 cycles, at 1 Hz, followed by a pull-to-failure conducted at 33 mm/ sec. Load and displacement data were recorded at 500 Hz. Additionally, digital video tracking was used to determine the plastic displacement at the repair site. Figure 2: A SutureTak Double Pulley sample prior to mechanical testing. Results: The larger ultimate load of the Interconnected Knotless SutureTak (693 ± 44 N) was significantly different from that of the SutureTak Double Pulley constructs (357 ± 25 N). These results are shown in Figure 3*. There were no significant differences between the two groups in plastic displacement/ gap formation, results shown on next page in Table 1*. Figure 1: An Interconnected Knotless SutureTak sample prior to mechanical testing. Figure 3: Ultimate load results. (*Data on file) © 2015, Arthrex Inc. All rights reserved. LA1-00017-EN_A Table 1: Cyclic plastic displacement using digital video tracking of the two constructs. (*Data on file) Conclusion: The Interconnected Knotless SutureTak® construct provides a mechanically superior repair when compared to the knotted SutureTak® Double Pulley. Cyclic Displacement (mm) Interconnected Knotless Double Pulley SutureTak® Significance Video Tracking Cycles 1-5 Cycles 6-100 1.8 ± 0.7 2.1 ± 0.6 p = 0.526 1.1 ± 0.5 0.9 ± 0.3 p = 0.589

Circumferential Teeth Spear for 3.9 mm Knotless Corkscrew Anchor, and 2.6 FiberTak Anchors

AR-1941CT

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