Dataset Information

The use of a synthetic shoulder patch for large and massive rotator cuff tears - a feasibility study.

ABSTRACT:

Background

The aim of this study was to explore the feasibility of using a non-absorbable biocompatible polyester patch to augment open repair of massive rotator cuff tears (Patch group) and compare outcomes with other treatment options (Non-patch group).

Methods

Participants referred to orthopaedic clinics for rotator cuff surgery were recruited. Choice of intervention (Patch or Non-patch) was based on patient preference and intra-operative findings. Oxford Shoulder Score (OSS), Shoulder Pain and Disability Index (SPADI), and Constant score were completed at baseline and 6?months. Shoulder MRI was performed at baseline and 6?months to assess fat fraction and Goutallier classification pre- and post- treatment. Feasibility outcomes (including retention, consent and missing data) were assessed.

Results

Sixty-eight participants (29 in the Patch group, 39 in Non-patch group) were included (mean age 65.3?years). Conversion to consent (92.6%), missing data (0% at baseline), and attrition rate (16%) were deemed successful feasibility endpoints. There was significant improvement in the Patch group compared to Non-patch at 6?months in OSS (difference in medians 9.76 (95% CI 2.25, 17.29) and SPADI: 22.97 (95% CI 3.02, 42.92), with no substantive differences in Constant score. The patch group had a higher proportion of participants improving greater than MCID for OSS (78% vs 62%) and SPADI (63% vs 50%) respectively. Analysis of the 48 paired MRIs demonstrated a slight increase in the fat fraction for supraspinatus (53 to 55%), and infraspinatus (26 to 29%) at 6?months. These differences were similar and in the same direction when the participants were analysed by treatment group. The Goutallier score remained the same or worsened one grade in both groups equally.

Conclusions

This study indicates that a definitive clinical trial investigating the use of a non-absorbable patch to augment repair of massive rotator cuff tears is feasible. In such patients, the patch has the potential to improve shoulder symptoms at 6?months.

Trial registration

ISRCTN, ISRCTN79844053, Registered 15th October 2014 (retrospectively registered).

SUBMITTER: Cowling P

PROVIDER: S-EPMC7140555 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The use of a synthetic shoulder patch for large and massive rotator cuff tears - a feasibility study.

Cowling P P Hackney R R Dube B B Grainger A J AJ Biglands J D JD Stanley M M Song D D Conaghan P G PG Kingsbury S R SR

BMC musculoskeletal disorders 20200407 1

<h4>Background</h4>The aim of this study was to explore the feasibility of using a non-absorbable biocompatible polyester patch to augment open repair of massive rotator cuff tears (Patch group) and compare outcomes with other treatment options (Non-patch group).<h4>Methods</h4>Participants referred to orthopaedic clinics for rotator cuff surgery were recruited. Choice of intervention (Patch or Non-patch) was based on patient preference and intra-operative findings. Oxford Shoulder Score (OSS), ...[more]

PMID: 32264949

Similar Datasets

Project description:PurposeTo determine the significance of initial and residual rotator cuff tear defect size on the need for revision surgery or additional nonsurgical therapy, in a consecutive group of patients undergoing partial repair of massive rotator cuff tears.MethodsA retrospective chart review was carried out for all arthroscopic rotator cuff repairs performed by a single surgeon between January of 2013 and December of 2016. All patients with massive rotator cuff tears (>30 cm2) who underwent partial repair were included in the study. Outcomes for the surgical procedure were measured based on the necessity for revision surgery or adjunct therapy, including steroid injections or additional physical therapy after initial release from care.ResultsIn total, 1954 patients who underwent arthroscopic rotator cuff repair were identified. Thirty-eight of these met the inclusion criteria. Those patients undergoing revision surgery represented 5.2% (2/38) of the series and had an average initial/residual tear defect area of 45.0/7.0 cm2. Patients requiring adjunct therapy represented 7.9% (3/38) of the series and possessed an average initial/residual tear defect size of 40.0/16.0 cm2. The remaining 33 (86.9%) patients did not require revision surgery or adjunct therapy at a minimum follow-up of 2 years. There was no significance between initial and/or residual rotator cuff tear defect size and the need for revision surgery. However, there was a significant difference in the mean residual defect size in the patients requiring additional nonoperative treatment after initial release from care (P = .012).ConclusionsThere was no relationship between residual defect size after partial repair and the need for revision surgery. Patients who returned for additional nonoperative treatment after being released from care were noted to have a statistically larger residual defect size at the time of index surgical intervention. Only 5% of patients underwent subsequent surgery at an average of more than 4 years' follow-up, suggesting that partial repair of massive rotator cuff tears can provide a durable, joint-preserving intervention.Level of evidenceLevel IV, Therapeutic Case Series.

Dataset Information

The use of a synthetic shoulder patch for large and massive rotator cuff tears - a feasibility study.

Background

Methods

Results

Conclusions

Trial registration

Publications

The use of a synthetic shoulder patch for large and massive rotator cuff tears - a feasibility study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets