Superior capsular reconstruction with ArthroFlex acellular dermal allograft - does graft failure matter?

Evaluating the role of graft integrity on outcomes: clinical and imaging results following superior capsular reconstruction

These authors sought to evaluate the relationship of clinical outcomes to graft integrity in patients following superior capsular reconstruction (SCR) in 34 patients with minimum 2-year follow-up. Patients underwent an arthroscopic SCR using an acellular dermal allograft (ArthroFlex; Arthrex). In addition to superior capsular reconstruction, 14% of patients underwent subscapularis repair. The biceps tendon was managed by tenodesis in 31% of shoulders and tenotomy in 29% of shoulders, and it was preserved in 31% of shoulders. In the remaining 9% of shoulders, tenodesis had been performed during a prior operation.

Four patients (12%) underwent subsequent surgery (3 reverse total shoulders and 1 latissimus transfer) and were excluded from further analysis. 

The mean percent Simple Shoulder Test (SST) improved 22 to 79, the ASES score from 28 to 80, the SANE from 51 to 74 and the VAS from 6.6 to 1.5. 

21 shoulders had follow up MRIs which revealed graft failure in 62% (13 of 21). 6 grafts failed at the humeral side, 4 failed at the glenoid side, and 3 were midsubstance graft failures. 

The graft failure rate in this study is consistent with that found in other reports: 50% (link) and 55% (link)

Radiographic evidence of graft failure did not have a statistically significant effect on SST, ASES, SANE, or VAS scores.

The authors concluded that graft healing after SCR might not be an independent predictor of success and that clinical improvement in patients undergoing SCR may be due to other aspects of the procedure, including partial rotator cuff repair, debridement, and biceps management. They state, "Given the expense of additional anchors and allograft material, further work will need to be done to better understand the mechanism in which clinical improvements are seen in patients undergoing this complex procedure."

Comment: Another recent article (see this link) reports failure of this graft in spite of active recellularization, revascularization, and remodeling

Good shoulder function in cases of graft failure has been reported previously (see this link and this link)

As pointed out in a recent post (see link), the indications for superior capsular reconstruction in the management of massive cuff tears have yet to be defined. Further clinical research is needed to demonstrate an incremental value for SCR beyond that achieved with lesser procedures, such as partial rotator cuff repair, debridement, and biceps management (see link).

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How you can support research in shoulder surgery Click on this link.

Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link)

The smooth and move for irreparable cuff tears (see this link)

The total shoulder arthroplasty (see this link).

The ream and run technique is shown in this link.

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

Shoulder rehabilitation exercises (see this link).

Superior capsular reconstruction for massive rotator cuff tears - what do the reviews say?

While there is enthusiasm for the use of superior capsular reconstruction in the treatment of massive, irreparable cuff tears (see link, link, link, link) other reports have shown a bit more modest outcomes  (see link, link, link, link, link, link, link,). 

Thus, it is timely to consider three recent reviews of this procedure.

First: Superior Capsular Reconstruction Indications, Techniques, and Clinical Outcomes

"Despite its rapid growth in popularity and several biomechanical studies evaluating the technique, clinical outcome literature for superior capsular reconstruction remains limited to date."

Second: Superior Capsular Reconstruction for Massive Rotator Cuff Tears A Critical Analysis Review

"Arthroscopic superior capsular reconstruction with fascia lata autograft or humeral dermal allograft is a surgical option, with multiple studies showing statistically significant improvement in short-term outcomes for both pain and function among younger patients with massive irreparable rotator cuff tears. The long-term clinical effectiveness and value have yet to be determined."

"No comprehensive quality-of-life or cost-comparison analyses are available to compare superior capsular reconstruction, reverse total shoulder arthroplasty (rTSA), tendon transfer, and partial rotator cuff repair for the treatment of massive irreparable rotator cuff tears. However, the potential higher cost of superior capsular reconstruction and the lack of long-term clinical outcomes or revision data suggest that either an attempt at repair or primary arthroplasty may be more cost-effective than superior capsular reconstruction."

"Long-term outcome data are essential to determine the role of superior capsular reconstruction for young patients with massive irreparable rotator cuff tears."

"Superior capsular reconstruction using fascia lata autograft may provide a different biomechanical and biological healing environment compared to acellular dermal allograft. Thus, the clinical outcome data between the 2 graft methods should not be generalized."

Third: Outcome Comparison of Graft Bridging and Superior Capsule Reconstruction for Large to Massive Rotator Cuff Tears: A Systematic Review

A systematic review was performed via a comprehensive search of PubMed, Embase, and the Cochrane Library. Studies of Graft Bridging (GB) or Superior Capsular Reconstruction). Twenty-three studies were included in this review.  Overall, both procedures demonstrated improvement of clinical outcomes. When compared with group SCR, group GB had significantly higher mean differences of the Constant-Murley score (41.9 vs 19.8), American Shoulder and Elbow Surgeons score (39.3 vs 33.8), visual analog scale score for pain (4.4 vs 3.4), and active external rotation at side (15.3 vs 9.3). 

No statistically significant difference was detected in the mean difference of active forward flexion, internal rotation, abduction, and graft healing rate between the groups. The complication rates were 0.84% (2 of 238) in group SCR and 0.67% (4 of 593) in group GB.

These authors concluded that graft bridging showed significantly better clinical and functional outcomes postoperatively than SCR, with a similar complication rate. The available fair-quality evidence suggested that GB might be a better choice for large to massive RCT. More high-quality randomized controlled studies are required to further evaluate the relative benefits of the 2 procedures.

Comment: With respect to non-arthritic massive irreparable cuff tears, we recognize that the clinical presentation varies widely from minimal symptoms, to stiffness, to painful crepitance, to pseudoparalysis. Because these tears are usually chronic, a good try at rehab directed at optimizing passive and active motion is indicated (see link). It is impressive to see patients referred for a reverse total shoulder who are improved to the point of satisfaction by this approach. For patients with retained active elevation, a smooth and move procedure (see link) can provide improved comfort and function without the prolonged down time associated with soft tissue reconstruction or arthroplasty.

As can be seen from the reviews summarized above, the indications for, surgical technique and graft choice used, and the results of superior capsular reconstruction differ widely among authors. 

We've much yet to learn about the treatment for the different symptoms associated with irreparable cuff tears.

How you can support research in shoulder surgery Click on this link.

Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link).

How to x-ray the shoulder (see this link).

The total shoulder arthroplasty (see this link).

The ream and run technique is shown in this link.

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

The smooth and move procedure for irreparable rotator cuff tears (see this link).

Shoulder rehabilitation exercises (see this link).

Superior capsular reconstruction - 62% graft failure.

Evaluating the Role of Graft Integrity on Outcomes: Clinical and Imaging Results Following Superior Capsular Reconstruction

These authors evaluated clinical outcomes and graft integrity in patients following superior capsular reconstruction (SCR) in thirty-four consecutive patients.

All patients had a preoperative diagnosis of massive irreparable rotator cuff tear with retraction to the level of the glenoid. Additionally, a preoperative diagnosis of pseudoparesis was present in 23% of shoulders (n=8 of 35 shoulders).

Patients underwent an arthroscopic débridement, decompression, and partial rotator cuff repair with arthroscopic SCR utilizing an acellular dermal allograft.

The mean preoperative scores were SST 21.6 ± 17.6, ASES 28.3 ± 10.1, SANE 50.6 ± 22.1, and VAS 6.6 ± 1.7. 

The mean postoperative outcomes were SST 79.1 ± 19.6, ASES 79.9 ± 17.4, SANE 74.3 ± 18.7, and VAS 1.5 ± 2.2. 

There was statistically significant improvement in SST, ASES, and VAS following SCR.

 

Torn grafts were defined as having discontinuity from the glenoid to the greater tuberosity on 2 consecutive T2-weighted MRI images in the coronal plane. MRI imaging revealed graft failure in 62% (n=13 of 21) of shoulders. Of the shoulders with graft failure, six grafts failed at the humeral side, four failed at the glenoid side, and three were mid-substance graft failures.

Radiographic evidence of graft healing did not have a statistically significant effect on SST, ASES, SANE, or VAS scores.

The authors concluded that given the high rate of graft failure without a significant difference in clinical outcomes, graft healing after SCR might not be an independent predictor of success. The improved clinical improvement in patients undergoing SCR may be due to other known beneficial aspects of the procedure, including partial rotator cuff repair, débridement, and biceps management.

Comment: This small study may be insufficiently powered to detect the differences in outcome between patients with intact and those with failed SCRs.

Nevertheless, it is worth considering the authors' question: "is the benefit of SCR more related to cuff integrity or to the non-SCR elements of the SCR surgery?".

An alternative approach to the surgical management of irreparable rotator cuff tears in patient with retained active elevation is shown in this link.

How you can support research in shoulder surgery Click on this link.

Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link).

How to x-ray the shoulder (see this link).

The ream and run procedure (see this link).

The total shoulder arthroplasty (see this link).

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

The smooth and move procedure for irreparable rotator cuff tears (see this link).

Shoulder rehabilitation exercises (see this link).

Superior capsular reconstruction - where are we?

Arthroscopic superior capsule reconstruction with Teflon felt synthetic 1 graft for irreparable massive rotator cuff tears: Clinical and radiographic results at minimum 2-year follow-up

These authors, including the originator of the SCR, reviewed their two year minimum outcomes in 35 shoulders having arthroscopic superior capsule reconstruction with Teflon felt synthetic 1 graft for irreparable massive rotator cuff tears:

They reported that SCR using Teflon grafts of either one or three layers significantly improved 

the ASES score by 21, for one-layer graft; and by 31 for three-layer graft.

the VAS score for motion pain by 3.2,  and by 3.0.

and muscle strength in shoulder abduction by 11.9 N,  and by 10.9 N,

Active elevation at final  follow-up was significantly greater in the three-layer-graft group (142° ± 27°) than in the one-layer-graft group (107° ± 42°) (P = 0.006). 

One year after SCR, the acromiohumeral distance in the three-layer-graft group was significantly greater than preoperatively, whereas in the one-layer-graft group it was not. The acromiohumeral distance diminished with time.

On postoperative MRI, none of the patients in the three-layer-graft group had graft tears, while two patients had graft tear and one patient had severe synovitis after one-layer-graft SCR.

Comment: It is of interest that up to now the materials used for SCR have included biological autogenous fascia lata, biological acellular dermal matrix (GraftJacket, ArthroFlex ® SCR), and now the non-biological Teflon graft.

The study compared the results two non-randomized sets of patients operated on during different time intervals: in the first 15 cases (group 1), the synthetic graft was made from one layer (2.9 mm thick) of Teflon felt. The remaining 20 cases (group 2) were treated by SCR by using three layers (8.7 mm thick) of Teflon felt. It is otherwise unclear how patients wound up in each group, thus their comparability is uncertain.

Another issue is that the preoperative active elevation (flexion) for the shoulders treated ranged from 20 to 160 degrees. This is a huge variation. Shoulders with retained active elevation can be well managed with simpler, safer, and less expensive procedures than a SCR (see this link).  

In order to understand the value (effectiveness divided by the cost) of the growing number of different approaches to the irreparable cuff we will need higher quality studies that accurately characterize the preoperative to postoperative change for each patient, stratified by their preoperative shoulder function and pathology. 

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