Clinical trial NCT02943005: Post-operative Mobilisation After Rotator Cuff Repair
Official title: Post-operative Mobilisation After Rotator Cuff Repair: Sling Versus Nothing. A Randomized Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ASES score
timeFrame: 3 months
Secondary outcomes:
measure: Retear or non healing of the rotator cuff
timeFrame: 6 months
Other outcomes:
measure: Return to sports
timeFrame: 6 months
measure: Work absenteeism
timeFrame: 6 months
measure: Complications (i.e frozen shoulder)
timeFrame: 6 months
measure: Number of physiotherapy sessions needed.
timeFrame: 6 months
measure: VAS score
timeFrame: 1.5, 3, and 6 months
measure: Constant score
timeFrame: 1.5, 3, and 6 months
measure: SANE score
timeFrame: 1.5, 3, and 6 months
measure: ASES score
timeFrame: 1.5, 3, and 6 months
measure: Strength of arms in Jobe position
timeFrame: 6 months
Locations:
city: Meyrin
country: Switzerland
facility: La Tour Hospital
state: Geneva
Study officials:
affiliation: La Tour Hospital
name: Alexandre Lädermann, MD
role: PRINCIPAL_INVESTIGATOR
References: