Biologic Augmentation Devices

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CHAPTER 25 Biologic Augmentation Devices

Chronic massive rotator cuff tears remain a difficult problem to treat for orthopedic surgeons. Rotator cuff atrophy, tendon retraction and scarring, and potentially glenohumeral arthritis are some of the aggravating factors. These patients may have failed previous open or arthroscopic procedures, adding the variables of deltoid deficiency, multiple empty anchors, and failed suture material. Achieving excellent results in this unfavorable biologic environment is usually impossible. Good results, including pain relief and improved function, can be achieved if the joint is stabilized with functional rotator cuff attachment to the humeral head.

Arthroscopic repairs for chronic massive rotator cuff deficiency require a keen understanding of the rotator cuff anatomy and the personality of the specific tear. Advanced arthroscopic techniques are often used, including releases of the adherent cuff, side to side repairs, bone marrow venting, and judicious placement of anchors. Even if the rotator cuff is secured to bone there is still much to do; there are many accounts of poor outcomes in this patient population after good-quality repair by a skilled surgeon. Often, a poor biologic environment leads to recurrent tears prior to healing. Until recently, there has been little available to improve the unhealthy biology.

Augmentation for rotator cuff surgery has been at the forefront of research and development in recent years, yielding several products, most of which have not acquired widespread popularity. Xenograft materials are available, including porcine small intestine submucosa (SIS) (Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Warsaw, Ind), fetal bovine dermis (TissueMend Soft Tissue Repair Matrix, Stryker Orthopaedics, Mahwah, NJ), porcine dermal collagen—Zimmer Collagen Repair Patch (Zimmer, Warsaw, Ind) and Permacol (Tissue Science Laboratories, Aldershot, UK), equine pericardium (OrthADAPT Bioimplant, Pegasus Biologics, Irvine, Calif). Some reported problems with these grafts include foreign body reactions mimicking infection, suture pull-out, loss of range of motion, and clinical failure.18 Synthetic materials are also available for augmentation, including polyurethane urea bands (Artelon, Artimplant, Lansdale, Pa), knitted polyester, polyethylene terephthalate, fiber mesh (Mersilene mesh, Ethicon, Somerville, NJ) and the expanded polytetrafluoroethylene patch (Gore-Tex Expanded PTFE Patch, W.L. Gore & Associates, Flagstaff, Ariz). There are limited reports with these synthetic materials in rotator cuff surgery and the failures have stemmed from foreign body reaction, bone resorption, and retears at the graft tendon junction.913

As early as 1978, human allograft tissue was used for augmentation of rotator cuff defects. These initial attempts with freeze-dried allograft tissue had mixed results. Acute rejection, infection, and clinical failure have limited its use.14,15 Presently, the allograft of choice is acellular human dermal matrix, GJA (GRAFTJACKET Matrix, Wright Medical Technology, Arlington, Tenn). This material is an aseptically handled, acellular human dermal tissue that is processed to maintain an intact collagen structure while avoiding cross linking. The GRAFTJACKET has proven to be a good matrix for in situ tissue engineering in tenocyte models and has demonstrated superior biomechanical properties in cadaveric studies.16,17 Histiologic and biomechanical data have been very promising in rat, canine and, most recently, primate models.1820 Postoperative biopsy at 3 months of one patient demonstrated cellular and blood vessel infiltration, lack of inflammatory response, and neotendon formation.21 This material has demonstrated promising initial clinical results at several centers and is our preferred augmentation device.2226

HISTORY AND PHYSICAL EXAMINATION

Chronic massive tears usually occur in patients older than 45 years and are less common in the younger patient population. The symptoms include chronic aching and weakness in the shoulder that worsens with abduction and external rotation. Catching, locking, and crepitation may also be present. Symptoms increase noticeably at night and sleep is frequently interrupted. In the most severe cases, shoulder elevation and external rotation are weak or impossible.

A comprehensive examination of the shoulder is necessary for all patients, complete with specific tests for the rotator cuff, starting with inspection and comparison to the unaffected side to evaluate for atrophy of the rotator cuff musculature. Humeral head subluxation and deltoid incompetence are easily assessed on many patients with inspection and palpation. Active and active-assisted range of motion are also tested. Active elevation may be severely limited but passive motion is often preserved.

Muscle testing starts with the arm at the side to test the infraspinatus and subscapularis muscles with internal and external rotation. The subscapularis can also be isolated with the belly press or lift-off test. The supraspinatus is tested with the arm in 60 degrees of abduction and 45 degrees of forward flexion, and the shoulder held in maximum internal rotation. The patient attempts to elevate as the examiner places progressive downward pressure. Impingement and acromioclavicular arthritis often coincide with rotator cuff pathology, so patients undergo specific tests for those entities as part of the complete examination.

DIAGNOSTIC IMAGING

Four standard views of the shoulder are obtained in all patients with rotator cuff problems:

The gold standard for imaging of the soft tissues around the shoulder, including the rotator cuff, is magnetic resonance imaging (MRI). This study provides the most information when a powerful 1.5-T magnet is used, with specialized shoulder coils and current software. Standard three-plane sequences should be obtained for T1- and T2-weighted images. Large full-thickness tears are easily visualized on the T2 coronal oblique images. The T1 sagittal oblique images are useful for visualizing the muscle bellies of the rotator cuff to determine the degree of atrophy. The axial oblique images are useful to evaluate the subscapularis and biceps tendons, because they are often involved in large and massive tears and are best visualized on this sequence.

Often, the treatment of a large or massive rotator cuff tear may follow failed open or arthroscopic surgery. In this case, it is best to obtain MRI images after intra-articular injection of dilute gadolinium-saline solution (1:100). This enhances visualization of intra-articular structures as well as the rotator cuff, biceps tendon, and old anchors in a revision setting. The MRI scan provides the most information to help determine the possibility of a primary repair; however, the decision to repair primarily, augment, or bridge is always made at the time of arthroscopy.

INDICATIONS AND CONTRAINDICATIONS

The indications and contraindications for bridging and augmentation of rotator cuff defects are still being defined. For bridging, the best demographic factor is motivated patients younger than 60 years with massive irreparable tears who have severe disabling pain and well-maintained active motion. An intact biceps tendon is helpful because it facilitates sewing the graft in anteriorly. Fatty infiltration of the rotator cuff musculature and superior migration of the humeral head are acceptable variables. Augmentation is typically used for tears that are at risk for failure with primary repair. These include rotator cuffs with repairs under tension, chronic large tears, fatty degeneration, poor tendon quality, or a small residual defect following a large repair. Age is a confounding variable because older patients are more at risk for retear but are also less likely to incorporate the graft successfully, likely because of the senescence of mesenchymal stem cells.26

Relative contraindications for both procedures include moderate glenohumeral osteoarthritis or rotator cuff arthropathy, immunocompromised state, and heavy smoking. Patients older than 60 years are potential candidates but outcomes may not be equivalent to those in the younger age group.26 Older patients with cuff tears, osteoarthritis, restricted motion, and little pain are not candidates for this procedure. These patients are best served with a reverse total shoulder arthroplasty.

TREATMENT OPTIONS

Treatment options for massive rotator cuff tears are limited in the very young population. Primary repair, either arthroscopically or with a miniopen repair, is possible. Repairing massive tears with compromised tissues dramatically increases the risk of failure with either technique. In this situation, it is best to augment with a biologic scaffold to reinforce the tenuous repair. In our opinion, alternatives to repair, such as reverse total shoulder arthroplasty, latissimus dorsi transfer, glenohumeral joint fusion, and arthroscopic débridement with partial repair, are second attempts, or salvage may be considered if the allograft fails. In addition to other shortcomings, these are all nonanatomic solutions. Latissimus dorsi transfers have demonstrated good results in certain patient populations but the postoperative immobilization is likely tolerated only by the most compliant of patients.27,28 Reverse total shoulder arthroplasty appears to be a good option for patients older than 70 years with limited function.29 In the younger population, arthroplasty plays a small role because of the possibility of multiple revision surgeries over the long term. Glenohumeral joint arthrodesis sometimes offers excellent pain relief but function is limited when compared with other techniques that preserve the glenohumeral joint.30 For the very young patient, the best option is probably patch augmentation with acellular human dermal matrix (GJA; Wright Medical Technology). There is a burgeoning interest in nonstructural biologic options, including bone morphogenic proteins and growth factors. In the future, these could be added to primary repairs or grafts to improve rotator cuff healing rates.31

Patients with large rotator cuff tears, preserved function, and minimal discomfort can be treated conservatively in the short term. Corticosteroid injections combined with physical therapy offer symptomatic relief only. Unfortunately, the natural history predicts that the tear will enlarge and the joint may progress to rotator cuff arthropathy if the tendon is not surgically reattached to the tuberosity. At this point, the best option for most patients is an attempt at repair with an augmentation if necessary.

Arthroscopic Techniques

Patch Augmentation of Rotator Cuff Tears

The technique described here is for augmentation of primarily repaired rotator cuff tears that appear to be at risk for failure. At-risk repairs include those with residual defects, poor-quality tissue, size larger than 3 cm, and previous failed repair attempts. The technique for biologic rotator cuff replacement has been described.23

Graft Measurement.

Accurate measurements of the tear are needed to appropriately size the graft. The knotted suture device allows simple and precise measurement of the dimensions of the tear (Fig. 25-1). It is an arthroscopic measurement tool made of braided suture with knots placed 1 cm apart that can be pulled through a knot pusher. The length is measured between the tip of the knot pusher on one of the knots and a grasper that holds the free end of the device (Fig. 25-2). In the medial to lateral dimension, 1 cm of graft will overlap the tuberosity and an additional 1 cm will overlap the repaired cuff; 6 mm should be added to the mediolateral and anteroposterior dimensions to allow for suture placement 3 mm from each edge.

Suture Passing.

The STIK sutures are passed in order, starting with the anterior suture (9 o’clock) and progressing toward the posterior stitch. All sutures are shuttled with a 45- or 60-degree suture hook to pass Suture Shuttles (Conmed Linvatec, Largo, Fla). The position of the first STIK and each subsequent STIK suture can be estimated using a knotted suture measuring device. All sutures are passed while viewing from the lateral portal and working from the posterior portal. The anterior-most stitch is the exception; it is not easily approached from the posterior portal. Instead, the suture hook is introduced through the anterior portal and passed through the anterior cuff, just anterior to the primary rotator cuff repair. Several inches of suture shuttle are fed into the joint; the suture hook then can be removed and the free end of the shuttle brought out the same anterior cannula. The eyelet is loaded with the corresponding 9 o’clock STIK suture, which can then be shuttled through the tissue. Once passed, the 9 o’clock STIK suture is stored outside the anterior cannula (Fig. 25-4). The remaining STIK sutures can be passed using the suture hook in the posterior cannula. The suture shuttle is retrieved out the anterior cannula and the corresponding STIK sutures shuttled out the posterior cannula (Fig. 25-5). When passing the remaining STIK sutures, it is critical that each subsequent suture be passed lateral to the previous one. This stay lateral technique is critically important when augmenting a rotator cuff repair. For example, the 11 o’clock STIK is passed with a suture hook, grabbing tissue approximately 1 cm medial to the original repair. The shuttle is retrieved on the lateral side of the 9 o’clock STIK suture. The subsequent three STIK sutures are passed in the same fashion, always staying lateral (Fig. 25-6). A crochet hook is used to retrieve and bring the 9 o’clock suture out the posterior cannula with the other four STIK sutures.

Rotator Cuff Bridging Reconstruction

If a primary repair is impossible, a good option for some patients is a bridging reconstruction. This procedure is considered off-label for FDA purposes. Similar to an augmentation, the procedure begins with a complete glenohumeral and subacromial diagnostic arthroscopy.

Lateral Fixation.

Pass and tie the remaining sutures from the anchors on the lateral edge. Insert additional anchors and pass simple sutures as needed (Fig. 25-15). At the completion of the procedure, turn off the arthroscopic pump and observe the bone marrow as it flows from the vents on the tuberosity, forming a red blanket over the graft—the “crimson duvet” (Fig. 25-16).

PEARLS& PITFALLS

SUMMARY AND CONCLUSIONS

More than 80 procedures have been performed at SCOI to date, with very few complications. There has only been one infection in an immunocompromised patient that responded to arthroscopic irrigation, débridement, and antibiotics. The graft itself is acellular, eliminating the possibility of graft rejection. Recently, 2-year follow-up data became available for the first 13 patients treated with GRAFTJACKET bridging technique at our institution.32 Of the 13 patients, 12 were satisfied with their results. Postoperatively, the Constant scores increased to 87.3 from 53.8 preoperatively (P = .0001). The mean modified UCLA score increased to 29.8 from 18.4 (P = .0001). MRI data is also convincing; 12 of 13 patients demonstrated full incorporation of the graft into native tissue at 1 year.32 Currently, a multicenter prospective randomized study is in progress to study GRAFTJACKET allograft augmentation of rotator cuff repairs; however, 2-year follow-up data are not yet available.

At this point, the exact mechanisms for the success of this operation are unknown. Most likely, the graft works to reduce and contain the humeral head into the glenoid (preventing boutonniere deformity) and allowing the deltoid to function more efficiently by maintaining the integrity of the anterior-posterior force couple. It is also possible that attaching the remaining cuff musculature to the humerus supplies some benefit. Continued research and engineering will improve graft options and the ability to regenerate tissue. Further research is needed to determine the ideal fixation configuration, need for other biologic enhancement with growth factors or platelet-rich plasma, and whether there is an age limit for the marrow stem cells to provide in-growth potential to the graft.

Arthroscopic allograft rotator cuff augmentation or bridging reconstruction are technically challenging procedures that require significant preoperative planning and practice. We believe that any surgeon with interest and desire can learn the appropriate steps. We recommend perfecting the technique on an ALEX shoulder model prior to attempting these procedures on a patient. With practice and experience, the individual steps continue to evolve at our institution in efforts to make it more efficient and straightforward. We believe that the future of this technique is bright because it provides an excellent option for patients with complex rotator cuff tears.

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