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November 16, 2023
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Augmentation with onlay dermal allografts may enhance rotator cuff repair

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The management of large and massive rotator cuff tears presents considerable challenges for shoulder surgeons.

Despite improvement in functional outcomes, a substantial proportion of these tears are prone to retear, necessitating the exploration of diverse surgical strategies to optimize outcomes. In recent years, one approach that has gained traction involves the utilization of grafts, such as xenografts, synthetic grafts and allografts, to augment the reparative process. The primary objective of this technique is to enhance the structural integrity of the repair and improve postoperative outcomes. Notably, among the available graft options, patch augmentation utilizing dermal allografts has emerged as the most employed method, exhibiting promising results in terms of biomechanical, structural and functional outcomes.

treatment algorithm for patients with rotator cuff tear
Figure 1. The authors' treatment algorithm for patients with rotator cuff tear and rotator cuff healing index is shown. RCT: rotator cuff tear; RoHI: rotator cuff healing index; AP: anteroposterior; BMD: bone mineral density.

Source: Patrick J. Denard, MD, and Ignacio Pasqualini, MD

Assessment of patient suitability

Dermal allograft augmentation is commonly indicated for patients with large rotator cuff tears (3 cm to 5 cm), previous unsuccessful rotator cuff repairs or patients with chronic tears with compromised tissue quality and no advanced glenohumeral osteoarthritis (Hamada grades 1 and 2). Prior to the surgical intervention, a crucial step involves the preoperative assessment to ascertain the feasibility of repairing the tear. This assessment involves a comprehensive evaluation of the patient’s MRI scans, focusing on factors such as tear size, tissue quality and the degree of retraction exhibited by the tear.

To assess the appropriateness of graft augmentation in patients with Hamada grades 1 and 2 and to determine the risk of retear, the rotator cuff healing index can be employed. This index is a scoring system that aids in determining the need for graft augmentation by considering age, tear size, retraction, fatty infiltration, bone mineral index and work activity in these patients. Our threshold score for considering the addition of a dermal allograft in rotator cuff repairs is seven points, although a lower threshold may be considered based on surgeon preference. The rationale for this threshold is healing drops from approximately 66% to 30% at this level. Additionally, studies on dermal allograft augmentation have generally shown improvement from approximately 40% to 50% without augmentation to approximately 80% with augmentation. The authors’ treatment algorithm for patients with rotator cuff tear and rotator cuff healing index are presented in Figure 1.

Surgical technique

The surgical procedure entails the application of regional anesthesia on a patient placed in the lateral decubitus position, followed by the execution of a diagnostic arthroscopy. This is accomplished by employing a posterior viewing portal in conjunction with an anterior working portal. The subscapularis is routinely evaluated with a 70° arthroscope. Subsequently, attention is directed toward the subacromial space, wherein a lateral percutaneous portal is established. This portal is established low, parallel to the rotator cuff and greater tuberosity footprint in anticipation of graft augmentation. This approach allows the subsequent graft to be delivered over the rotator cuff in an onlay fashion. The tear is meticulously inspected, enabling the assessment of the tear pattern and tendon mobility.

The senior author’s preference is a double-row repair when possible; however, in the case of poor tissue quality or smaller tears, a load-sharing rip-stop fixation construct may also be used. For the double-row repair the senior author uses a FiberTak SpeedBridge (Arthrex Inc.) technique, which is completed with two to three 2.6 FiberTak RC (Arthrex Inc.) soft anchors on the medial row and sutures fixated laterally with two knotless anchors. The load-sharing rip-stop technique construct has been described in detail previously by Patrick J. Denard, MD, and colleagues.

Because the need for augmentation is confirmed preoperatively with the rotator cuff healing index, the graft can be prepared on the back table by an assistant while the repair is performed. A 1-mm or 2-mm dermal allograft is prepared by placing two 0.9-mm cinch sutures into the lateral corners of the graft. The medial corners of the graft are prepared by passing two #0 sutures in a simple configuration (Figure 2). The graft construct is loaded onto the graft spreader by crisscrossing and tucking the #0 sutures from the medial aspect of the graft into the inner cleat positioned on the handle of the device. Each lateral cinch suture is then directly docked into the outer cleat of the graft spreader (Figure 2).

Graft preparation
Figure 2. Graft preparation (a) and loading onto graft spreader (b) are shown.

Upon loading the dermal allograft onto the graft spreader, the graft is folded through the retraction of the articulating arm by sliding the button toward the handle. The graft is inserted via the lateral cannula via an 8-mm to 10-mm flexible cannula (Figure 3). The graft is deployed by opening the articulating arm and advanced medially just past the musculotendinous junction (Figure 4).

Portal placement for graft delivery
Figure 3. Portal placement for graft delivery is shown.
Graft delivery
Figure 4. Graft delivery is shown.

The graft is secured into the medial rotator cuff with two independent knotless soft anchors. Using a skid as a guide, an anchor is inserted off the lateral edge of the acromion and passed through the graft and medial rotator cuff to a depth of 12 mm, ensuring it does not compromise the glenohumeral joint. One pass is made through the graft and medial rotator cuff, and a second pass is made either more medially into the rotator cuff tissue alone, or through the graft and rotator cuff again, about 5 mm from the second pass, to form a mattress configuration (Figure 5).

Graft medial fixation using a knotless soft anchor
Figure 5. Graft medial fixation using a knotless soft anchor forming an oblique mattress configuration is shown.

The graft spreader is removed, and the lateral corners of the graft are secured in the greater tuberosity with the lateral suture limbs and two self-punching 3.5-mm knotless anchors (Figure 6).

Graft lateral fixation with sutures loaded into two self-punching knotless anchors
Figure 6. Graft lateral fixation with sutures loaded into two self-punching knotless anchors is shown.

Rehabilitation follows a standardized protocol for rotator cuff repair. The patient is placed in a sling for 6 weeks postoperatively. Range of motion is initiated at 6 weeks, followed by strengthening at 12 weeks postoperatively and then gradual advancement to normal activities.

Technique rationale

Despite the progress made with techniques, such as double-row repair, the retear rates following rotator cuff repair remain consistently high at approximately 25% overall and even higher for large and massive tears. This presents a significant challenge for both orthopedic surgeons and their patients, emphasizing the imperative for continued efforts to enhance treatment outcomes. Graft augmentation has emerged as a promising alternative technique for rotator cuff repair, demonstrating encouraging results. James R. Bailey, MD, and colleagues conducted a systematic review that examined the outcomes of graft augmentation compared to isolated rotator cuff repair. The study revealed graft augmentation led to a reduction in retear rates (OR=0.39; 95% CI, 0.15-1.01) and a significant improvement in patient-reported outcome measures when compared to rotator cuff repair performed without augmentation. Therefore, in addition to imparting additional strength during the implantation phase, dermal allograft is anticipated to act as a supportive scaffold that promotes the healing process. This scaffold is conducive to optimal tissue regeneration, thereby facilitating a gradual and sustained improvement in the strength of the repair over time.

While the results are promising, it is important to determine patient suitability for graft augmentation. We highly recommend utilizing the rotator cuff healing index as a valuable tool in this assessment process. It has been demonstrated that patients with a score of six points demonstrate a retear rate of 66% when the repair is not augmented, whereas those with a score of seven points exhibit a significantly lower retear rate of 38% when graft augmentation is employed. Therefore, a score of seven points is deemed reasonable for indicating the use of a dermal allograft to improve the chances of successful healing in these cases.

Advantages of using this technique include enhanced tendon integrity, the convenience of pre-measured and sized grafts, ease of graft insertion and placement, as well as simplified suture management on medial suture limbs. However, it is important to note there are some disadvantages, including the higher cost due to the use of specialized materials and the fact that sutures are not passed through the rotator cuff and graft in an interpositional fashion, which may provide greater pull-out strength.

While further long-term and higher-level studies are still needed, initial findings indicate that rotator cuff repair with dermal allograft augmentation is a safe procedure that exhibits superior outcomes compared with rotator cuff alone when appropriately indicated.