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

2021 ◽  
Vol 30 (7) ◽  
pp. e440
Author(s):  
Priyadarshi Amit ◽  
Martyn Snow
2020 ◽  
pp. 026921552097885
Author(s):  
Chris Littlewood ◽  
Marcus Bateman ◽  
Stephanie Butler-Walley ◽  
Sarah Bathers ◽  
Kieran Bromley ◽  
...  

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults ( n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation ( n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation ( n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery.


2021 ◽  
pp. 175857322110598
Author(s):  
Bruno Mazuquin ◽  
Marcus Bateman ◽  
Alba Realpe ◽  
Steve Drew ◽  
Jonathan Rees ◽  
...  

Background We investigated clinical equipoise across surgical members of the British Elbow and Shoulder Society (BESS) in relation to rehabilitation following rotator cuff repair. Method An online survey explored clinical equipoise regarding early patient-directed versus standard rehabilitation after rotator cuff repair to inform the design of a national randomised controlled trial (RCT). It described different clinical scenarios relating to patient age, tear size, location and whether other patient-related and intra-operative factors would influence equipoise. Results 76 surgeons completed the survey. 81% agreed/ strongly agreed that early mobilisation might benefit recovery; 57% were neutral/ disagreed that this approach risks re-tear. 87% agreed/ strongly agreed that there is clinical uncertainty about the effectiveness of different approaches to rehabilitation. As age of the patient and tear size increased, the proportion of respondents who would agree to recruit and accept the outcome of randomisation reduced, and this was compounded if subscapularis was torn. Other factors that influenced equipoise were diabetes and non-secure repair. Conclusion Surgical members of BESS recognise uncertainty about the effectiveness of different approaches to rehabilitation following rotator cuff repair. We identified a range of factors that influence clinical equipoise that will be considered in the design of a new RCT.


Medicina ◽  
2021 ◽  
Vol 57 (5) ◽  
pp. 491
Author(s):  
Donghyun Yi ◽  
Hwanyong Lim ◽  
Jongeun Yim

Background and Objectives: The purpose of this study was to investigate the effects of microcurrent stimulation on pain, shoulder function, and grip strength in patients with rotator cuff repair. Materials and Methods: This randomized single-blind controlled trial was conducted on inpatients of the rehabilitation department, and included 28 patients who underwent rotator cuff repair. Participants were randomly assigned to the experimental group (n = 14), treated with microcurrent stimulation, and the control group (n = 14), treated with false microcurrent stimulation. The microcurrent stimulation administered to the experimental group underwent general physical therapy and microcurrent stimulation three times a week for 4 weeks. Results: Changes in pain, range of motion in shoulder, simple shoulder test, and grip strength were assessed before and after the intervention. Both groups showed a significant decrease in pain and shoulder function (t = 27.412, 22.079, 19.079, and 18.561; p < 0.001), and grip strength showed a significant increase (t = −8.251 and −9.946; p < 0.001). The experimental group that underwent microcurrent stimulation exhibited a significant effect on pain, shoulder function, and grip strength compared with the control group that underwent false microcurrent stimulation (t = −2.17, −2.22, and 2.213; p = 0.039, 0.035, and 0.036). Conclusions: This study confirmed that microcurrent stimulation is effective for the treatment of rotator cuff repair patients.


2019 ◽  
Vol 28 (10) ◽  
pp. 1918-1927 ◽  
Author(s):  
Paolo Avanzi ◽  
Luca dei Giudici ◽  
Antonio Capone ◽  
Gaia Cardoni ◽  
Gianluigi Lunardi ◽  
...  

2017 ◽  
Vol 45 (9) ◽  
pp. 2000-2009 ◽  
Author(s):  
Pietro Randelli ◽  
Carlo Alberto Stoppani ◽  
Carlo Zaolino ◽  
Alessandra Menon ◽  
Filippo Randelli ◽  
...  

Background: Rotator cuff tear is a common finding in patients with painful, poorly functioning shoulders. The surgical management of this disorder has improved greatly and can now be fully arthroscopic. Purpose: To evaluate clinical and radiological results of arthroscopic rotator cuff repair using 2 different techniques: single-row anchor fixation versus transosseous hardware-free suture repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Sixty-nine patients with rotator cuff tears were enrolled: 35 patients were operated with metal anchors and 34 with standardized transosseous repair. The patients were clinically evaluated before surgery, during the 28 days after surgery, and at least 1 year after the operation by the use of validated rating scores (Constant score, QuickDASH, and numerical rating scale [NRS]). Final follow-up was obtained at more than 3 years by a QuickDASH evaluation to detect any difference from the previous follow-up. During the follow-up, rotator cuff integrity was determined through magnetic resonance imaging and was classified according to the 5 Sugaya categories. Results: Patients operated with the transosseous technique had significantly less pain, especially from the 15th postoperative day: In the third week, the mean NRS value for the anchor group was 3.00 while that for transosseous group was 2.46 ( P = .02); in the fourth week, the values were 2.44 and 1.76, respectively ( P < .01). No differences in functional outcome were noted between the 2 groups at the final evaluation. In the evaluation of rotator cuff repair integrity, based on Sugaya magnetic resonance imaging classification, no significant difference was found between the 2 techniques in terms of retear rate ( P = .81). Conclusion: No significant differences were found between the 2 arthroscopic repair techniques in terms of functional and radiological results. However, postoperative pain decreased more quickly after the transosseous procedure, which therefore emerges as a possible improvement in the surgical repair of the rotator cuff. Registration: NCT01815177 ( ClinicalTrials.gov identifier).


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