Rotator Cuff Clinical Trial
Official title:
Post-operative Mobilisation After Rotator Cuff Repair: Sling Versus Nothing. A Randomized Prospective Study.
The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus tendon. The goal is to offer to patients a simplified rehabilitation management, with a faster recovery, less pain and a quicker return to normal life.
Rotator cuff tear is a frequent problem, increasing with age1. Thus arthroscopic repair is a
frequent surgery. Despite this important number of cuff repair, the re-tear rate varies from
20 to 90% depending on tear severity and type of repair1,2. Many factors are implicated in
tendon healing and post-operative clinical results. Some are unchangeable (age, tear size,
chronicity…) but some are under the surgeon control like the surgical technique and the
post-operative rehabilitation protocol. It exists many surgical repair techniques6, 7, with
a massive development of technology during the last twenty years. However in terms of
rehabilitation, there is only few studies and evidence of best practices4. The main aspect
on which the surgeon can act, is the immobilization time. Actually, standard protocols
include an immobilisation of 4 to 6 weeks before physiotherapy beginning5.
A recent review of the literature3 has highlighted five studies comparing different
rehabilitation protocols, which include different immobilization periods ranging from 0 to 8
weeks, and different types of mobilization (under physiotherapist supervision or not, with
machine or not). They found a similar rate of re-tear between the different protocols. But
early passive motion enables to improve the range of motion during first 3-6 months, with
similar results at one year.
However in all these studies, all patients had to wear a sling for at least 4 weeks, even in
the early mobilization group. But the investigators don't know if this sling is really
useful, probably not if the investigators follow the logic of faster recovery and same long
term results with early mobilization. At our best knowledge, no study has sought to compare
the usefulness of sling wearing after a rotator cuff repair. Removing sling could simplify
rehabilitation and should provide a return to normal function faster, with greater
satisfaction and a similar rate of re-tear.
The aim of this study is to compare rehabilitation with the wearing of a sling, to
rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus
tendon.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00739947 -
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
|
||
| Recruiting |
NCT03752034 -
Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
|
N/A | |
| Withdrawn |
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Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears
|
N/A | |
| Withdrawn |
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Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing
|
Phase 3 | |
| Active, not recruiting |
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Safety of Treatment of Shoulder Repair
|
||
| Recruiting |
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|
N/A | |
| Completed |
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Single Shot vs Continuous Interscalene Block for Rotator Cuff Repair
|
N/A |