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Post-operative Mobilisation After Rotator Cuff Repair

Post-operative Mobilisation After Rotator Cuff Repair: Sling Versus Nothing. A Randomized Prospective Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943005
Enrollment
80
Registered
2016-10-24
Start date
2016-09-30
Completion date
2019-12-31
Last updated
2016-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURERotator cuff repair

Sponsors

La Tour Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over 18 years old * Small tear (\< 3cm) of the supraspinatus tendon * Arthroscopic cuff repair

Exclusion criteria

* Lesion of the anterior or posterior rotator cuff * Significant other trauma of the involved upper member (e.g. associated scapular or clavicular fractures, acromioclavicular dislocation) * Preoperative shoulder stiffness * Inability to follow properly post-surgery recommendations.

Design outcomes

Primary

MeasureTime frameDescription
ASES score3 monthsClinical score (0-100)

Secondary

MeasureTime frameDescription
Retear or non healing of the rotator cuff6 monthsUltrasound control

Other

MeasureTime frameDescription
Number of physiotherapy sessions needed.6 monthsClinical evolution
Return to sports6 monthsYes/no
VAS score1.5, 3, and 6 monthsGraded between 0 and 10
Work absenteeism6 monthsMonths
SANE score1.5, 3, and 6 monthsClinical scores number between 0-10
ASES score1.5, 3, and 6 monthsClinical scores number between 0-100
Strength of arms in Jobe position6 monthsStrength measurement in kilo according to the technique of Int Shoulder Surg Collin et al. In press
Constant score1.5, 3, and 6 monthsClinical scores number between 0-100
Complications (i.e frozen shoulder)6 monthsDescription of complication

Countries

Switzerland

Contacts

Primary ContactAlexandre Lädermann, MD
alexandre.laedermann@gmail.com227197555
Backup ContactAdrien Switzguebel, MD
adrien.schwitzguebel@gmail.com227197555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026