Abstract
BackgroundThe 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).MethodsParticipants 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.ResultsSixty-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.ConclusionsThis 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 registrationISRCTN, ISRCTN79844053, Registered 15th October 2014 (retrospectively registered).
Highlights
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)
Of the 72 recruited into the study four patients were withdrawn at baseline: 3 did not have a rotator cuff full thickness tears (RoCT) at baseline (2 on magnetic resonance imaging (MRI) and 1 on arthroscopy), and one patient asked to be withdrawn having undergone no surgical procedure
A total of 68 participants were allocated to an intervention arm: 29 to the patch group and 39 to the non-patch group (Fig. 3)
Summary
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). There are many options available, including specialised rehabilitation, simple arthroscopic surgery including debridement [17,18,19,20], long head of biceps tenotomy, bursectomy [21, 22], various tendon transfers [23, 24] through to formal repair of the tendon. Current published outcomes for all these measures have been relatively successful, but re-tear rates are often high, and clinical outcomes can deteriorate after 2 years [25, 26] This has led to the development of further techniques, including use of patch to augment repair, subacromial spacer insertion and superior capsular reconstruction [27]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
