ISAKOS Congress 2021

2021 ISAKOS Biennial Congress Paper

 

Dermal Patch Augmented Versus Standard Rotator Cuff Repair: Randomised Controlled Trial

Priyadarshi Amit, MS, DNB, MRCSEd, MCh, FRCS, London UNITED KINGDOM
Martyn Snow, FRCS, Birmingham UNITED KINGDOM

The Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UNITED KINGDOM

FDA Status Not Applicable

Summary

A human acellular dermal patch augmented cuff repair did not improve functional outcome or healing at 12 months post-surgery compared to standard double row rotator cuff repair.

Abstract

Aim

The aim of this study was to compare the patient reported outcome measures and cuff healing at 12 months between standard and augmented rotator cuff repair with human acellular dermal patch.

Background

Recurrent rotator cuff tear following repair has been reported in up to 60% of cases. Maximising mechanical repair through double row fixation has failed to significantly improve healing rates, consequently, there is focus on the biological enhancement of healing. Patch augmentation is one method to augment repair, however, there are very few comparative studies assessing their efficacy.

Methods

A randomised controlled trial was conducted over patients undergoing arthroscopic repair of rotator cuff tear measuring between 1-5 cm. Patients were excluded for associated osteoarthritis, irreparable tear, or significant subscapularis tear. A total of 63 patients were recruited to the study between 2016 - 2019. Twenty-three patients were excluded leaving 40 patients in the final study population. They were randomised to one of two groups: augmented (cuff repair with human acellular dermal patch) and standard (double-row arthroscopic cuff repair). Functional assessment was performed at 3, 6, 9, and 12 months post-surgery with rotator cuff healing quantified on MRI scan at 12 months using Sugaya’s classification. Functional outcome was assessed using American Shoulder and Elbow score (ASES), Quick Disability of Arm, Shoulder and Hand (Quick-DASH) score, Constant-Murley score and Western Ontario Rotator Cuff (WORC) index. Statistical analysis was performed with chi-square, paired and unpaired t-test to compare the outcomes between the two groups.

Results

The mean age was 65.75 years in the augmented group and 69.25 years in standard group. The male:female ratio was 11:9 in the augmented group and 12:8 in the standard group. There was no significant difference in age, gender, tear size, fatty infiltration and pre-operative clinical outcome measures (p < 0.05) between the two groups. The mean ASES, qDASH, Constant, and WORC improved from 36.6, 52.2, 31.6, and 32.6 pre-operatively to 79.6, 17.1, 83.9, and 77.4 at 12 months in augmented; and from 31.9, 50.9, 31.4, and 25.2 pre-operatively to 74.8, 20.1, 71.1, and 74.9 at 12 months post-operatively in the standard group (p < 0.05). There was no significant difference in one-year clinical outcome measures between the two groups (p > 0.05). Compared to control group, greater number of patients in the augmented group achieved outcome scores more than the value of minimum clinically important difference (MCID) in three of the outcome measures (ASES 90% vs 84.2%, qDASH 85% vs 73.7%, Constant 100% vs 72.7%, WORC 84.2% vs 90%, augmented vs standard respectively). On MRI, re-tear (Sugaya grade 4 and 5) was observed in 25% (4 of 18) in augmented and 27.7% (5 of 18) patients in standard group (p = 1.000). There was no difference in the 12-months post-operative Goutallier fatty infiltration grades between the two groups (p = 0.495). The progression of fatty infiltration grades on post-operative MRI as compared to pre-operative MRI was noted in 28.5% (2 of 7) in augmented and 50% (5 of 10) patients in standard group, although the difference was not statistically significant (p = 0.662).

Conclusions

A human acellular dermal patch augmented cuff repair did not improve or healing at 12 months post-surgery compared to standard double row rotator cuff repair, however there was a trend of better clinical outcome scores and lower progression of fatty infiltration (although, not statistically significant) in dermal patch group.

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