J Shoulder Elbow Surg (2010) 19, 104-109
www.elsevier.com/locate/ymse
Arthroscopic GraftJacket repair of rotator cuff tears Ivan Wong, MDa, Joseph Burns, MDb, Stephen Snyder, MDb,* a b
Orthopaedic Surgery, McMaster University, Hamilton, ON, Canada Southern California Orthopaedic Institute, Van Nuys, CA, USA Hypothesis: Management of massive, degenerative, and irreparable rotator cuff tears is challenging. Excessive re-tear rates and poor clinical outcome after standard repair have led to alternative methods of treatment. Tendon transfers and shoulder arthroplasty have had mixed results; both are invasive procedures with high potential morbidity. We began performing rotator cuff augmentation and replacement using GraftJacket allograft acellular human dermal matrix as a biologic minimally invasive alternative in this difficult population almost 6 years ago. This article highlights our preferred arthroscopic technique and early results. Materials and methods: From January 2004 to June 2007, 45 patients (36 men, 9 women) with massive rotator cuff tears were treated arthroscopically with the GraftJacket allograft. All patients completed a preoperative University of California, Los Angeles (UCLA) score. Follow-up was a minimum of 2 years (range, 24-68 months) and patients completed UCLA, Western Ontario Rotator Cuff (WORC), and American Shoulder and Elbow Surgeons (ASES) scores. Results: Analysis was performed using the 3 validated outcomes measurement scores. The mean UCLA score increased from 18.4 preoperatively to 27.5 postoperatively (P < .000). The average WORC score was 75.2, and the ASES score was 84.1 at the final follow-up. Discussion: Evidence-based data to outline an algorithm for management of irreparable rotator cuff tears is being developed. We documented significant clinical improvement with arthroscopic rotator cuff reconstruction using the GraftJacket allograft acellular human dermal matrix. The procedure is safe and associated with high patient satisfaction, without the morbidity of tendon transfer or arthroplasty. For those few cases where further surgery is required, no bridges are burned. The early success of this procedure warrants further study with more patients, longer follow-up, and higher levels of evidence-based investigation. Level of Evidence: Review Article. Ó 2010 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Rotator cuff tear; arthroscopic reconstruction; irreparable; shoulder; GraftJacket acellular human dermal matrix
Large, massive, and degenerative rotator cuff tears are a formidable surgical challenge because they are difficult to repair and the failure rate is unacceptably high.2-6 Current alternatives to attempted repair include reverse total shoulder arthroplasty, muscle transfers, or glenohumeral *Reprint requests: Dr Stephen J. Snyder, 6815 Noble Ave, Van Nuys, CA 94105-3729. E-mail address:
[email protected] (S. Snyder).
joint fusion. We believe that partial cuff repair, coupled with biologic bridging for large and massive rotator cuff tears, offers an alternative treatment that does not burn any bridges if further surgery is required in the future. This article describes our recommended surgical technique for arthroscopic rotator cuff reconstruction using the GraftJacket allograft acellular human dermal matrix (Wright Medical Technology, Inc., Arlington, TN) and updates our previously presented early follow-up data.1
1058-2746/2010/$36.00 - see front matter Ó 2010 Journal of Shoulder and Elbow Surgery Board of Trustees. doi:10.1016/j.jse.2009.12.017
Arthroscopic GraftJacket rotator cuff tear repair
Materials and methods This study did not require Investigational Review Board approval. From the first GraftJacket MaxForce Extreme allograft bridging technique implanted in January 2004, 80 patients have been operated on using this technique, and 45 (36 men and 9 women), with average age of 53.6 years (range, 39-67), were available for a minimum 2-year follow-up. All patients completed a preoperative University of California, Los Angeles (UCLA) score. UCLA, Western Ontario Rotator Cuff (WORC), and American Shoulder and Elbow Surgeons (ASES) scores were completed postoperatively.
Surgical indications and contraindications The indications and contraindications for using the GraftJacket allograft to bridge large and massive rotator cuff defects are evolving. Ideally, patients must be motivated, intelligent, younger people with disabling pain but intact biceps tendons, and wellmaintained active motion with a functioning subscapularis muscle. We have used the biceps tendon as an anterior anchor point for the graft, with no known adverse outcomes. Younger patients with an intact deltoid often can compensate for dysfunctional rotator cuffs and maintain adequate motion. Older patients with little pain, poor motion, and arthritis are less likely to fully benefit from the procedure and are often better candidates for reverse total shoulder arthroplasty or nonoperative care.1 Glenohumeral arthritis is a relative contraindication because significant stiffness may develop in these patients with inadequate pain relief. Immunocompromised patients and heavy smokers are also relatively contraindicated. Fatty infiltration, muscle atrophy, muscle retraction, humeral head position, and prior surgery are acceptable variables for inclusion.
Imaging Standard shoulder radiographs, including anteroposterior, lateral, and axillary views, are important in evaluating the presence and degree of glenohumeral arthritis. The acromial morphology, the presence and location of metal, plastic, or bioresorbable suture anchors, and the degree of humeral head migration are also evaluated. Magnetic resonance imaging (MRI) scans are ordered on all patients and help to characterize the rotator cuff tear. Size, retraction, atrophy, fatty infiltration, biceps pathology, and bioabsorbable (radiolucent) suture anchor location must all be evaluated. Tear size and the presence of fatty infiltration can affect outcome and reparability of rotator cuff tears. We use this information to counsel patients, develop appropriate expectations for surgery, and plan the surgical procedure. Predicting the tears that will be reparable and those that will be irreparable can be difficult. In general, irreparable tears will be large, retracted, chronic, atrophic, with fatty infiltration, and often, prior surgical repairs have failed. We always tell the patient that every attempt will be made to reconstruct all or a portion of the tear with GraftJacket, but the final decision will be made intraoperatively.
Reconstruction planning When reconstructing irreparable rotator cuff tears, we occasionally use a 2-stage approach. If the surgeon believes a de´bridement,
105 subacromial decompression, and partial repair is the best first option, the reconstruction can be done in a staged fashion. Stage 1 consists of subacromial decompression, tear assessment, partial repair, if possible, and suture hemming of the cuff tendon stump. It is of some concern that a subacromial decompression may create a bleeding bony surface to which a newly implanted graft may adhere rather than adhering to the greater tuberosity. Six to 8 weeks later, if the patient has adequately recovered from the first procedure and has regained range of motion, but is still symptomatic, the second stage can be performed and the graft implanted. Some believe the first-stage de´bridement procedure is the gold standard for irreparable rotator cuff tears. Staging the graft reconstruction helps to select only those patients in whom the first procedure has failed.
Surgical technique All rotator cuff surgery is performed with the patient in the standard lateral decubitus position. Bony prominences are carefully padded, and an axillary roll is placed. Ten pounds of balanced suspension in 70 of abduction is used for glenohumeral work, 15 lbs in 15 of abduction is used for standard bursal work, and 10 lbs in approximately 45 of abduction is used as a middle position for accessing the lateral aspect of the greater tuberosity from the bursal space. A complete, standardized video-recorded arthroscopic glenohumeral evaluation is always performed, viewing from both the posterior and the anterior portals.7 The articular side of the rotator cuff is evaluated and sparingly de´brided, as is the greater tuberosity. Articular-side releases of the rotator cuff are also performed as needed from within the glenohumeral joint space to create an adequate cuff margin for suturing. In the bursal space with the arm adducted, a full evaluation of the anatomy is again performed. A lateral arthroscopy portal is established at the midpoint of the tear, often referred to as the ‘‘50-yard line.’’ Bursal tissue is de´brided to maximize visualization. Subacromial decompression is performed if needed. The rotator cuff tear is identified and carefully dissected away from the surrounding tissue. Bursal-side releases are performed at this time. We occasionally use a posterolateral-viewing portal when inserting the GraftJacket.
De´bridement and evaluation The cuff tear is closely evaluated for size, tissue quality, and mobility. The extent of the tear must be clearly visualized anteriorly, posteriorly, and mediallydusually far enough to clearly see the spine of the scapula. Scar tissue releases are performed, and the bursa is de´brided. The greater tuberosity is prepared with gentle shaving of the cortical bone and placement of several ‘‘bone marrow vents’’ using an arthroscopic punch lateral to the attachment site of any fixation anchors.
Graft measurement and preparation We perform our operations using 3 DryDoc (Linvatec, Largo, Florida) docking cannulae. We place a 7-mm cannula in both the standard posterior and anterior portals and an 8.2-mm DryDoc in the midlateral portal.
106
Figure 1
I. Wong et al.
A knotted device is used for measuring the suture.
The tear size is measured with a knotted suture-measuring device (Fig. 1) that is made with a No. 1 braided suture with knots tied 1 cm apart. It is loaded into a standard knot pusher and can be guided around the cuff defect with the tip of the pusher. A grasper holding the suture tip can pull the suture through the end of the suture passer and hold it in place on the opposite side of the tissue being measured. The size of the defect is measured by counting the number of knots between the instruments. Four measurements are taken: (1) anterior to posterior adjacent to the medial stump of residual cuff tissue, (2) anterior to posterior at the edge of the articular cartilage, (3) medial to lateral adjacent to the biceps tendon, and (4) medial to lateral adjacent to the posterior edge of residual cuff tissue. Short-tailed interference knotted (STIK) sutures are prepared on the back table by tying mulberry-type knots on the end of a No. 2 suture. The GraftJacket Maxforce Extreme allograft is rehydrated and then cut to the proper size as measured with the knotted suture tool. The midline of the graft on the lateral edge is marked with a surgical marker. The STIK sutures are placed around the anterior, medial, and posterior graft, 3 mm from the edge and 4 mm apart using a Keith needle. Four or 5 STIK sutures are placed along the medial edge of the graft, and 2 or 3 STIK sutures are placed along the anterior and posterior borders, ensuring that the knotted end is located on the smooth or ‘‘basement membrane’’ surface of the graft (Fig. 2). The opposite, ‘‘fuzzy,’’ side of the graft is the reticular side of the dermal tissue.
Corner anchor placement A triple-loaded suture anchor is inserted into the prepared bone at the posterior edge of the cuff tear (Fig. 3). The most posterior suture from the anchor is passed through the adjacent native cuff tissue and tied to stabilize the posterior edge. A second triple-loaded anchor is placed into the prepared tuberosity anteriorly, just behind the biceps tendon. The most anterior suture from the second anchor is passed through the rotator interval tissue or, more often, through the adjacent biceps tendon to anchor it and create a strong, stable anterior edge to anchor the graft. It is important to make 2 separate skin incisions for these 2 anchors. The midglenoid cannula is located just lateral and midway between these anchors, and suture management will take place between them (Fig. 4).
Suture passing The GraftJacket is placed on a moistened towel clamped around the arm adjacent to the lateral cannula. It is oriented so that the
Figure 2 The GraftJacket Maxforce Extreme allograft is shown with short-tailed interference knots in place and the lateral marking line.
Figure 3
Insertion of the corner suture anchors is shown.
posterior edge of GraftJacket faces the cannula when sewing to the posterior edge, the medial edge faces the cannula when sewing to the medial stump, and the anterior edge faces the cannula when sewing to the anterior biceps and cuff. Suturing is always performed in a consistent sequential manner. We begin posterior and proceed along the medial edge and finish with the anterior sutures. The first suture passed is the middle suture from the posterior anchor. It is retrieved out the lateral cannula and passed from bottom to top through the posterior-lateral corner of the GraftJacket using a straight Keith needle. A STIK is tied in the top end of the suture, and the slack is removed by pulling on the other end of the suture. Suture hooks with various curved needles are used to pass Super Shuttles (Linvatec) for all of the remaining STIK sutures. All stitching and shuttling is done through the posterior or anterior DryDoc portals. The Super Shuttle is passed through the respective tissue and grasped through the lateral portal (always staying anterior to the previously passed suture). The STIK sutures are loaded outside the lateral portal and pulled back through the lateral cannula and the cuff tissues (Fig. 5).
Arthroscopic GraftJacket rotator cuff tear repair
Figure 4 View from the posterolateral portal shows the lateral DryDoc cannula between the corner suture anchors.
Figure 5 Suture shuttle passage is shown through posterior cuff, with the grasper in the lateral portal and the GraftJacket allograft oriented with the posterior leaf facing the portal. Suture management is extremely important when arthroscopically reconstructing with a GraftJacket. The most important concept is to keep all sutures parallel to prevent entanglement. This can be easily done by sequentially passing each Shuttle stitch anterior to the prior one. Rotating the graft outside the lateral cannula can minimize confusion, so that the part of the cuff that is being sewn is the same part of the graft that is facing the cannula and no sutures need be crossed under others (Fig. 6).
Graft insertion After the posterior, medial and anterior STIK sutures are passed through the tissue, the graft is inserted down the lateral cannula. We use a ‘‘push-pull’’ technique (Fig. 7) after first folding the graft with the medial edge toward the cannula. The graft is pushed down the lateral cannula with a grasper while pulling the free ends of the STIK suture stored inside the posterior and anterior cannulas. The free ends of the anchored STIKS are tensioned to remove slack, causing the graft to unfold in the joint (Fig. 8).
107
Figure 6 Insertion of the posterior and anterior suture anchor stitches through the GraftJacket is shown with the Keith needle inferior to superior.
Figure 7 Push-pull technique of passage of the GraftJacket is shown through the lateral 8.2-mm DryDoc cannula.
Tie STIKs We begin tying the anterior STIKs by retrieving the knotted end and the corresponding free end of one of the sutures into the anterior DryDoc cannula. The sutures are tied with a sliding knot, ensuring that the post is on the strand that passes through the tissue and not the graft. We continue tying along the anterior, medial, and finally posterior edges until all STIKs are secure. Finally, we tie the 2 STIKs from the suture anchors to secure the corners of the graft to the anchor sites (Fig. 9).
Lateral fixation The remaining suture from each suture anchor is used to perform a standard single-row technique of cuff fixation by attaching the lateral edge of the graft to the prepared bone 5 mm away from the articular margin. Additional suture anchors are placed as
108
I. Wong et al.
Figure 8 The GraftJacket is shown unfolding inside the shoulder after tensioning sutures.
Figure 10 Placement of lateral sutures through the graft and anchoring the graft onto greater tuberosity is shown.
Figure 9 The short-tailed interference knots have been sequentially tied with knots on the cuff tissue. The blue line marks the midline of the lateral graft.
Figure 11 graft.
necessary. The middle anchor is usually placed a little more lateral than the first 2, allowing the option of adding a slight amount of tension to the graft when the 3 central sutures are passed. The colored midline mark on the lateral aspect of the graft is used to ensure a balanced suture line (Fig. 9). At the completion of the repair, the graft is firmly attached to bone laterally and to the remnants of the native tissue medially, posteriorly, and anteriorly (Fig. 10). The fluid inflow can be turned off and the bone marrow observed streaming out to cover the graft, forming the ‘‘crimson duvet’’ (Fig. 11).
Postoperative management Postoperatively, the patients are managed similar to those with large rotator cuff repairs. Patients are supported in an Ultra-Sling (Donjoy, Carlsbad, CA) for 6 weeks, removing it daily to perform Codman pendulum exercises. Formal therapy begins at 6 weeks.
Final view shows the crimson duvet covering the
Active elevation exercises allowed at 8 weeks and gentle strengthening at 12 weeks.
Results We have recently reviewed our first 45 patients treated with the GraftJacket Maxforce Extreme bridging technique with a minimum of 2 years of follow-up (range, 24-68 months). The mean modified UCLA score increased from 18.4 preoperatively to 27.5 postoperatively (P < .001). At the final follow-up, the average WORC score was 75.2, and the ASES score was 84.1. In 80 cases to date, one complication occurred requiring revision surgery. A deep wound infection developed in an immunocompromised patient, which resolved after
Arthroscopic GraftJacket rotator cuff tear repair arthroscopic irrigation and de´bridement and antibiotic treatment. There have been no cases of graft rejection.
Discussion We have had success with arthroscopic rotator cuff reconstruction using GraftJacket allograft acellular human dermal matrix in a bridging construct for irreparable rotator cuff tears. In our experience, it is safe and has high patient satisfaction without the morbidity of tendon transfers or arthroplasty. In the beginning of the series, cases typically took 3.5 to 4.5 hours. Using the technique described, our surgical time is now consistently less than 3 hours, and often 2.5 hours. Graft entanglement will obviously lengthen the case time, and every effort must be made to manage the graft and all sutures correctly and carefully. Fluid extravasation must be carefully monitored, and pump pressures are kept as close to 35 mm Hg as possible. Lateral positioning allows safe administration of controlled hypotensive anesthesia. Transient finger numbness and tingling is fairly common, lasting 2 to 3 days; however, a long-term neurapraxia did develop in 1 patient that resolved at 1 year. Because of this, we routinely take the arm out of traction for 15 minutes if the procedure lasts more than 2.5 hours, thus minimizing the risk of traction or compression related nerve injury. In cases of irreparable rotator cuff reconstruction, finding, de´briding, and mobilizing what is left of the rotator cuff can be a challenge. We will typically perform periglenoid release with an arthroscopic liberator tool and also use this tool to sharply separate a scarred muscle from the acromion before using a shaving or electrosurgical device. Appropriate graft sizing is important, and we therefore make use of the knotted suture measuring device to ensure accurate measurement. The necessity of careful suture management cannot be overstated. The concept of keeping sutures parallel and ‘‘staying anterior’’ to the previously retrieved STIK sutures when retrieving the Super Shuttle must be understood before this type of arthroscopic graft reconstruction is attempted. To this end, we recommend that every surgeon practice the technique on a shoulder model (ALEX model, SCOI’s CLASroom, Orthopaedic Learning Center courses) before attempting it on a patient. A prospective randomized multicenter study is currently progress to analyze the role of GraftJacket allograft augmentation of rotator cuff repairs, but no 2-year followup data are available at this time.
Conclusion Evidence-based data to outline an algorithm for management of irreparable rotator cuff tears is still in the early stages of development. Although many matrix
109 materials are now available for use in rotator cuff augmentation, none of them are rated for on-label use by the Food and Drug Administration (FDA) for replacement of rotator cuff defects greater than 1 cm. None of the companies supplying these materials advise or recommend that their matrix products should be used for cuff bridging, even though many of these materials are FDA-approved for on-label use for tissue augmentation and bridging smaller defects. We have shown significant clinical success in our patient series with arthroscopic rotator cuff reconstruction using the GraftJacket human dermal allograft. We have shown the procedure is safe and is associated with high patient satisfaction, without the morbidity of tendon transfer or arthroplasty. We believe the early success of this procedure warrants further study with more patients, longer follow-up, and higher levels of evidence-based investigation.
Disclaimer Dr Snyder is a consultant for and has received royalties from Wright Medical Technology as well as Conmed/ Linvatec Inc. Dr Burns is a consultant for Wright Medical Technology and Conmed/Linvatec and Mitek. Dr Wong, his immediate family, and any research foundations with which he is affiliated has not received any financial payments or other benefits from any commercial entity related to the subject of this article.
Supplementary data Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.jse.2009.12.017.
References 1. Bond JL, Dopirak RM, Higgins J, Burns J, Snyder SJ. Arthroscopic replacement of massive, irreparable rotator cuff tears using a graftjacket allograft: technique and preliminary results. Arthroscopy 2008;24: 403-9. e1. 2. Burkhart SS, Danaceau SM, Pearce CE. Arthroscopic rotator cuff repair: analysis of results by tear size and by repair technique-margin convergence versus direct tendon-to-bone repair. Arthroscopy 2001;17:905-12. 3. Gartsman GM, Khan M, Hammerman SM. Arthroscopic repair of fullthickness tears of the rotator cuff. J Bone Joint Surg Am 1998;80:832-40. 4. Hanusch BC, Goodchild L, Finn P, Rangan A. Large and massive tears of the rotator cuff: Functional outcome and integrity of the repair after a mini-open procedure. J Bone Joint Surg Br 2009;91:201-5. 5. Jones CK, Savoie FH. Arthroscopic repair of large and massive rotator cuff tears. Arthroscopy 2003;19:564-71. 6. Lo IK, Burkhart SS. Arthroscopic revision of failed rotator cuff repairs: technique and results. Arthroscopy 2004;20:250-67. 7. Snyder SJ. Shoulder Arthroscopy second edition. New York: Lippincott Williams & Wilkins; 2002. p. 23.