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Year : 2007  |  Volume : 1  |  Issue : 1  |  Page : 7-15    Table of Contents


 
ORIGINAL ARTICLE

Arthroscopic total rotator cuff replacement with an acellular human dermal allograft matrix

1 Department of Arthroscopic Shoulder Surgery and Sports Medicine, Lakeshore Orthopedics, 1650 S. 41st Street, Manitowoc, WI 54221, USA
2 Orthopedic Surgery and Sports Medicine, Oklahoma Sports and Orthopedic Institute, 4212 Waterfront Circle, Norman, OK 73072, USA
3 Arthroscopic Shoulder Surgery, Southern California Orthopedic Institute, 6815 Noble Avenue, Van Nuys, CA 91405, USA

Correspondence Address:
Ryan Dopirak
1650 S. 41st Street, Manitowoc
USA
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0973-6042.30673

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   Abstract 

Purpose: To describe the technique and short-term results of arthroscopic repair of irreparable rotator cuff tears using a GraftJacket® allograft. Although current rotator cuff repair techniques offer excellent results in most cases, there are still many instances where tendon repair is not possible. Allograft substitutes offer the advantages of saving bone stock, while maintaining anatomic integrity within the shoulder.
Materials and Methods: Between March 2003 and February 2004, 16 patients with massive, contracted immobile rotator cuff tears were treated with arthroscopic placement of a GraftJacket® allograft by a single surgeon. Patients were followed for 1-2 years. All were evaluated preoperatively and postoperatively using the modified University of California Los Angeles (UCLA) scoring system, Constant score and Simple Shoulder Test. MRI was performed postoperatively at 3 months and 1 year.
Results: At mean follow-up time of 26.8 months (range, 12-38 months), 15 of 16 patients were satisfied with the procedure. The mean UCLA score increased from 18.4 preoperatively to 30.4 postoperatively ( P = 0.0001). The Constant score increased from 53.8 to 84.0 ( P = 0.0001). Statistically significant improvements were seen in pain, forward flexion and external rotation strength. Thirteen displayed full incorporation of the graft into the native tissue, as documented on magnetic resonance imaging. There were no complications in this cohort of patients.
Conclusions: Our study supports GraftJacket® allograft as a viable solution for surgical salvage in select cases of massive irreparable rotator cuff pathology.


Keywords: Rotator cuff, graft jacket, biologics, shoulder arthroscopy


How to cite this article:
Dopirak R, Bond JL, Snyder SJ. Arthroscopic total rotator cuff replacement with an acellular human dermal allograft matrix. Int J Shoulder Surg 2007;1:7-15

How to cite this URL:
Dopirak R, Bond JL, Snyder SJ. Arthroscopic total rotator cuff replacement with an acellular human dermal allograft matrix. Int J Shoulder Surg [serial online] 2007 [cited 2018 Dec 14];1:7-15. Available from: http://www.internationalshoulderjournal.org/text.asp?2007/1/1/7/30673



   Intoduction Top


Tears of the rotator cuff tendons are a common source of shoulder pain and disability. In symptomatic patients who fail to improve with conservative measures, surgical intervention is often considered. Although both open and arthroscopic techniques of rotator cuff repair have been used with success, most shoulder specialists would agree that arthroscopic repair has now become the standard of care. With the continual advancement in arthroscopic instrumentation and techniques, successful repair of large and even some massive tears is now possible.[1],[2],[3],[4],[5],[6],[7],[8],[9] However, in a significant percentage of massive tears, a complete, tension-free repair is simply not possible, regardless of surgeon skill or experience. It has been estimated that up to 30% of rotator cuff tears may be irreparable.[10]

Many techniques have been developed to repair massive tears arthroscopically, with some degree of success. [11],[12],[13],[14],[15],[16],[17],[18] However, the quality of the residual rotator cuff tendon is often poor in these massive tears, which may predispose to persistent or recurrent tear in up to 41-94% of cases. [19],[20],[21],[22],[23]

Many surgical procedures have been advocated to decrease pain and restore overhead function in patients with irreparable rotator cuff tears. These procedures include subacromial decompression with debridement of the rotator cuff tendons, [24],[25],[26],[27],[28],[29] partial repair of the rotator cuff in order to restore a balanced 'force couple' about the shoulder,[30] latisimus dorsi or subscapularis tendon transposition[31],[32] and utilization of tendinous and fascial autograft or allograft tissues to augment or span the cuff defect.[33],[34],[35],[36],[37],[38],[39],[40] In patients with irreparable tears associated with arthritis, arthroplasty is currently the only available surgical option. [41],[42],[43],[44],[45]

Although many techniques have been described for the treatment of irreparable rotator cuff tears, none have been proven to be universally successful. Although rotator cuff debridement may provide short-term pain relief, functional improvement is limited and the durability of this treatment is questionable. Many patients with irreparable tears have already failed previous 'partial repairs,' so it would not be logical to recommend this to the patient a second time, when it has already proven unsuccessful. There is a substantial degree of morbidity associated with tendon transfers, and outcomes have been found to be unsatisfactory in a significant percentage of patients after these procedures.[10] Although arthroplasty is a reasonable solution for patients with rotator cuff tear arthropathy, it is not ideal for younger patients or for those without evidence of glenohumeral arthritis.

This first sentence should read "The purpose of this paper is to present our preferred technique for surgical treatment of massive irreparable rotator cuff tears - arthroscopic total rotator cuff replacement with GraftJacket Allograft (GJH). GraftJacket® is a freeze-dried acellular human dermal allograft matrix that is processed in a proprietary manner that preserves the vascular channels, collagen, elastin and proteoglycan constituents, while eliminating all cellular components [Figure - 1]. This minimizes the potential for viral disease transmission, while preserving strength and maximizing the potential for biologic incorporation of the allograft tissue. GraftJacket® allograft has been utilized in numerous surgical subspecialties with good success. No disease transmission has been documented after over 800,000 applications. [46],[47],[48],[49],[50],[51],[52],[53],[54],[55],[56],[57],[58],[59]

Operative technique

The patient is positioned in the standard lateral decubitus position. Ten pounds of traction are used to suspend the arm in 70 degrees of abduction and 20 degrees of forward flexion. The standard '15-point' glenohumeral examination is performed, paying particular attention to the degree of glenohumeral arthritis as well as the status of the biceps tendon, as it is often tenodesed and utilized to stabilize the anterior aspect of the GJA reconstruction.

After appropriate treatment of any intra-articular pathology, the cuff remnant is carefully mobilized with a liberator elevator and/or a Steinman pin above the glenoid. The coracohumeral ligament and rotator interval is not released since this tissue is also an important attachment site for the anterior edge of the graft. Great care is taken not to injure the suprascapular nerve at the spinoglenoid notch near the base of the acromial spine. A pencil-tip electrocautery tool may be utilized to free the tendon from capsular adhesions.

Once the intra-articular aspect of the cuff is adequately mobilized, the traction is changed to the bursoscopy position (20 degrees of abduction / 5 degrees of forward flexion). There are often adhesions between the rotator cuff remnant and the undersurface of the acromion; thus it is imperative to carefully and deliberately establish the proper plane of dissection, in order to preserve the integrity of the remaining tendon. If clinically indicated, an acromioplasty and distal clavicle resection may be performed at this time. However, as with any massive rotator cuff injury, the coracoacromial ligament should be preserved in order to prevent future anterior-superior escape of the humeral head.

Next, the arthroscope is transferred to the lateral portal to assess the tear pattern, tendon mobility and tissue quality. If the tendon can be mobilized to the medial edge of the greater tuberosity without excessive tension, then a standard repair is performed. If a tension-free repair cannot be achieved, we proceed with AGJA reconstruction.

As in a standard rotator cuff tear, a shaver is utilized to debride the rotator cuff footprint at the greater tuberosity. This serves to create bleeding bone surface. It is advisable to create a pattern of 4 or 5 'bone marrow vents' or 1-mm puncture holes in the tuberosity at least 1 cm lateral from the edge of the cartilage to enhance the egress of bone marrow elements that are thought to enhance healing and revitalization of the GJA [Figure - 2].

The defect in the cuff is next measured using a knotted suture as a measuring device [Figure - 3]. Four measurements are taken: 1) anterior to posterior adjacent to the medial cuff remnant, 2) anterior to posterior at the edge of the articular cartilage, 3) medial to lateral adjacent to the biceps tendon or the anterior aspect of residual cuff tissue and 4) medial to lateral adjacent to the posterior edge of residual cuff tissue. These dimensions are used to create a template for allograft sizing on the back table. After 30 min of hydration in sterile saline solution, the GraftJacket® is cut to the size of the template.

Three #2 permanent braided polyester sutures are then passed through the posterior cuff edge using a medium Crescent® suture hook (Linvatec, Inc., Largo, FL) and routine suture shuttling techniques [Figure - 4]. The sutures are stored and protected in plastic straws, called Suture Savers® (Linvatec, Inc., Largo, FL), outside the posterior cannula [Figure - 5]. This process is then repeated along the anterior edge of the cuff remnant incorporating the biceps tendon and rotator interval tissue when it is present [Figure - 6]. Anterior and posterior ThRevo® anchors (Linvatec, Inc., Largo, FL) are then placed into the prepared portions of the greater tuberosity through small stab incisions just lateral to the acromion at the anterior and posterior edges of the cuff tear a few millimeters lateral from the edge of the articular cartilage [Figure - 7].

Four to six short tail interference knotted (STIK) sutures are prepared using different colored #2 permanent braided polyester suture by tying a bulky interference knot on one end leaving a 5 mm tail. The STIK sutures are then passed through the medial edge of the GJA on the back table, 3 mm from the edge and approximately 5 mm apart, leaving the knotted end on the superior surface of the GJA. It is important to orient the graft with the smooth side (the epidermal basement membrane side) facing upward or toward the patient's head. The fuzzy side should be oriented to face the tuberosity bone to ensure more rapid incorporation [Figure - 8]. A 10-mm operating cannula with a removable outer rubber diaphragm is inserted into the anterior portal. From the posterior cannula, a Suture Shuttle Relay® is passed through the anterior aspect of the medial stump of cuff tissue via a 45° curved Spectrum suture hook. The shuttle is loaded with the corresponding free end of the medial STIK and then pulled back through the cuff tissue and stored outside the posterior cannula. This process is repeated for all of the medial STIK sutures, proceeding from anterior to posterior leaving a 5-6 mm gap between suture passes [Figure - 9]. In order to avoid catastrophic suture tangling, it is imperative to remain lateral in the anterior cannula (with respect to the previously passed sutures) when retrieving the shuttle relay. If any of the STIK sutures are inadvertently crossed, the GJA will twist as it is pulled into the joint.

The most posterior and medial suture from the posterior suture anchor is next retrieved out of the anterior cannula using the crochet hook. Again, this is a crucial step that if not carefully controlled will result in twisting of the Graft when it is pulled into the joint. Using a 'Keith' needle, the suture is passed through the GJA from inferior to superior at the posterior lateral corner of the graft, and a STIK is tied on the top side of the graft. The other end of the STIK suture is pulled to remove slack and seat the STIK on the Graft. Finally, the most anterior and medial suture from the anterior Super ThRevo® anchor is retrieved out of the anterior cannula. Using the previously described techniques, the suture is passed through the graft from inferior to superior, and a STIK is tied to the topside of the graft at its anterior lateral corner and the slack is removed [Figure - 10].

The GJA is then folded in half. The assistant gently pulls on the free ends of the medial STIKs from the posterior portal, thus guiding the graft through the anterior cannula and into the shoulder. If the graft is too large to fit through the cannula, the rubber diaphragm is removed. The ends of the sutures from the anterior and posterior anchors that were placed in the GJA should remain taut but are not used to guide the graft into the shoulder. Once the GJA is seated medially, the free ends of the anchored sutures are pulled taut, causing the STIK knots on the top corners of the GJA to hold the corners snuggly against the tuberosity. The anchored sutures are clamped with a 'rubber shod' clamp next to the skin to hold the GJA in place during the suturing process [Figure - 11].

An arthroscopic grasper is used to retrieve the knot of the most posterior STIK from the top of the GJA into the posterior portal. A crochet hook is used to pull the other end of this suture into the posterior cannula, and the suture is tied preferably with the knot on the cuff side and not on the GJA [Figure - 12]. This retrieving and tying process is repeated until all of the medial cuff sutures have been tied [Figure - 13].

Once the GJA has been secured at its medial edge, the posterior and anterior edges of the GJA are secured. Several methods have proven useful. The first method requires that both limbs of the posteromedial suture (located in the most medial Suture Saver) first be retrieved into the anterior cannula [Figure - 14]. Then, the suture strand from underneath the posterior edge of cuff tissue is retrieved back into the posterior cannula and loaded into the Expressew® stitching device. The Expressew® is placed through the posterior cannula and deployed to pass the suture through the posterior edge of the GJA [Figure - 15]. The suture is pulled back into the posterior cannula with a crochet hook and tied. The second technique uses a medium-sized crescent-shaped Spectrum suture hook (Linvatec, Largo, FL). Again, both sutures from a Suture Saver are retrieved into the anterior cannula, but this time the inferior one is pulled back into the posterior cannula. The Crescent hook is loaded with a Suture Shuttle Relay® device and passed through the anterior cannula. The tip of the needle is used to puncture the graft a few millimeters from the edge, and the Shuttle is passed and retrieved into the posterior cannula. The suture is loaded into the Shuttle and carried back through the GJA and into the anterior cannula. The suture tails are then tied. The process is continued for all remaining posterior and anterior stitches, thus securing the GraftJacket® allograft to the native tissues both anteriorly and posteriorly.

The remaining anchored sutures are now passed through the lateral edge of the GJA, using standard arthroscopic rotator cuff repair techniques [Figure - 16]. We prefer to use the 45 or 60° Spectrum suture hooks and Suture Shuttle Relay since it creates the smallest puncture hole in the GJA. One to three additional Super ThRevo® anchors may be used, depending on the size of the cuff defect and GJA. Often one of the three sutures in the anchor is passed through the native tissue, either the biceps and rotator interval anterior or the cuff remnant posterior, to secure them adjacent to the GJA [Figure - 17]. After passing the anchored sutures through the GJA, the suture pairs are stored in Suture Savers outside of the poster cannula. Once all the sutures are passed, the sutures are tied through a Crystal Cannula (Arthrex, Naples, FL) via the lateral portal.

After a final examination of the GJA, the pump is turned off to observe the flow of the bone marrow elements from the greater tuberosity, which include stem cells, platelets and vascular progenitor cells. The blood and bone marrow flows over the GJA, covering it like a rich red blanket. This process has been deemed 'The Crimson Duvet' and is of critical importance in the cellular repopulation and revascularization of the graft and formation of neo-tendon [Figure - 18].

Postoperatively, the arm is supported in an UltraSling® (DJ Orthopedics) for 6 weeks. Patients may remove the sling three to four times a day for scapular mobilization, as well as elbow, wrist and hand exercises. Pendulum exercises are initiated at 1 week, and range of motion exercises begin at 6 weeks. Progressive resistance exercises begin at 4 months.

Clinical results

To date, the senior author (SJS) has performed GJA total rotator cuff replacement in 39 patients with massive irreparable rotator cuff tears. Complete 12-month data is available for the first 16 patients.

The mean age of these first 16 patients requiring an AGJA procedure was 54.4 years. The mean size of the tear was 4.25 x 4.95 cm. All of the patients were evaluated preoperatively and postoperatively using subjective and objective outcome measures at 3 months, 6 months, 12 months and latest follow-up. The mean follow-up was 26.7 months (range 12-38 months) with a minimum follow-up of 1 year. The clinical results were scored according to the modified University of California Los Angeles (UCLA) score,[60] the Constant score[61] and the Simple Shoulder Test (SST).[62] A postoperative MRI arthrogram was also obtained at 3 months and at 1 year to evaluate the structural integrity of the repair.


   Results Top


At a mean follow-up of 26.7 months (range, 12-38 months), 15 of 16 patients were satisfied with their results. According to the modified UCLA shoulder score,[60] there were four excellent, nine good, three fair and zero poor results (75% good and excellent results). Overall, the mean UCLA score improved from 18.4 preoperatively to 30.4 postoperatively ( P = 0.0001). The mean pain score improved from 4.6 to 9.8 postoperatively ( P = 0.0001). Forward flexion increased from 106 degrees to 142 degrees ( P = 0.0001), with significant improvement in strength in forward elevation (2.5 to 4.2, P = 0.0001). External rotation strength improved from 2.6 to 4.4 ( P = 0.001). The average Constant score improved from 53.8 preoperatively to 84 postoperatively ( P = 0.0001). With respect to the SST evaluation, the percentage of patients able to perform each task consistently increased at the 3-month, 6-month and 1-year follow-up visits in all categories, except the ability to carry 20 pounds comfortably on the side of the rotator cuff deficiency.

All patients had an MRI at 3 months and 1 year postoperatively, in order to evaluate the structural integrity of the AGJA [Figure - 19]. Three patients experienced a radiographic failure of the allograft. The first two allografts failed within 3 months. The first graft failed at its insertion onto the greater tuberosity. The second graft failed at the medial leaflet and along the anterior border of the graft. The medial tissue in this patient was noted to be deficient intraoperatively, and the biceps tendon was not incorporated into the anterior leaflet. The third patient experienced a partial tear at the tuberosity insertion after a fall at 4 months postop. All three of these patients were satisfied at their latest follow-up, as their pain was substantially improved by the procedure. Their only complaint was lack of improvement in overhead strength.

To date, no patient has experienced an intraoperative or postoperative complication from the AGJA procedure. There have been no infections or allograft rejections.


   Discussion Top


A variety of surgical procedures have been described for the treatment of irreparable rotator cuff tears. However, none of these procedures have been consistently successful in decreasing pain and increasing shoulder function. Perhaps the simplest treatment option is subacromial decompression with debridement of the tear. This has been shown to result in significant reductions in pain and a modest improvement in function. [25],[26],[27],[28],[29] Rockwood et al . reported 83% satisfactory results at a mean of 6.5 years of follow-up.[63] However, results in patients treated with debridement alone may deteriorate over time.[64] Gartsman et al . found that repair of massive tears resulted in better outcomes, as compared to debridement alone.[65]

Some surgeons believe that partial repair of the rotator cuff is preferable to simple debridement, as it may create a balanced force couple and restore some rotator cuff function.[15],[30],[65] However, it is not known with certainty what percentage of the footprint must be restored in order to obtain acceptable results.

In younger patients, tendon transfer may be considered. Both latissimus dorsi and subscapularis tendons have been reported as viable options, depending on tear pattern.[31],[32] However, outcomes have been found to be unsatisfactory in a significant percentage of patients after these procedures.[10]

Reconstructive techniques using allograft tissues have been described by several authors. [33],[34],[35],[36],[37],[38],[39],[40] Nevasier used freeze-dried rotator cuff allografts to treat irreparable cuff tears and reported good to excellent results in 14 of 16 patients.[33] However, no subsequent studies have been able to reproduce these results.[66]

Recent animal studies suggest that biologic allograft tissues, such as GJA, may provide a framework for improved host cell incorporation and thus may provide an appropriate augmentation to the irreparable rotator cuff. [46],[47],[48],[49],[50],[51],[52],[53],[54],[55],[56],[57],[58],[59]

Additionally, recent basic science studies have evaluated the biologic and biomechanical attributes of the GJA in comparison to other biologic substitutes that are currently available for rotator cuff augmentation. Fini et al. evaluated rotator cuff tenocyte proliferation in three matrices: polystyrene wells (control), porcine small intestine submucosa (SIS) and human dermal matrix (GJA). Tenocytes cultured on GJA showed the highest levels of cellular proliferation. Additionally, type I collagen, prostaglandin and fibronectin synthesis was greatest in the GJA group, as compared to the other two groups. Based on these findings, the authors concluded that GJA may be more suitable than SIS as a biologic scaffold in the setting of massive rotator cuff tears.[67]

Barber et al. evaluated the load-to-failure strengths of several commercially available tendon augmentation xenografts and allografts, including human dermal grafts, porcine dermal grafts, bovine dermal grafts and porcine small intestine submucosal grafts. The GJA had the highest average load-to-failure force among all of the specimens tested. This finding was statistically significant ( P < 0.001).[68] These findings suggest that GJA is superior to other commercially available tendon augmentation grafts from a biomechanical perspective.

Despite these promising basic science studies, prior clinical studies have not yet proven that allograft biologic tissues will consistently produce good results in the treatment of massive rotator cuff tears. Schlamberg and Tibone found that porcine small intestinal submucosa xenografting is ineffective in reinforcing large and massive rotator cuff repairs and does not improve clinical outcome.[37]

In contrast, our preliminary data show that arthroscopic total rotator cuff replacement with GJA is a safe and effective treatment for massive irreparable rotator cuff tears at short-term follow-up, producing good clinical outcomes and functional improvement in the majority of patients. Although this data is encouraging, long-term follow-up is necessary to further define the role of total rotator cuff replacement in the treatment of irreparable rotator cuff tears.

 
   References Top

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    Figures

  [Figure - 1], [Figure - 2], [Figure - 3], [Figure - 4], [Figure - 5], [Figure - 6], [Figure - 7], [Figure - 8], [Figure - 9], [Figure - 10], [Figure - 11], [Figure - 12], [Figure - 13], [Figure - 14], [Figure - 15], [Figure - 16], [Figure - 17], [Figure - 18], [Figure - 19]


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