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Post-operative Mobilisation After Rotator Cuff Repair

NCT ID: NCT02943005

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Rotator Cuff

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rotator cuff repair with sling

Patients wear a sling during 4 weeks, they also move passively during this period. Then progressive active mobilization is done.

Group Type ACTIVE_COMPARATOR

Rotator cuff repair

Intervention Type PROCEDURE

Rotator cuff repair without sling

Patients don't wear any sling, they move passively in all axes during 4 weeks. Then progressive active mobilization is done.

Group Type EXPERIMENTAL

Rotator cuff repair

Intervention Type PROCEDURE

Interventions

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Rotator cuff repair

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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La Tour Hospital

OTHER

Sponsor Role lead

Responsible Party

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Adrien Schwitzguebel

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandre Lädermann, MD

Role: PRINCIPAL_INVESTIGATOR

La Tour Hospital

Locations

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La Tour Hospital

Meyrin, Canton of Geneva, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Alexandre Lädermann, MD

Role: CONTACT

Phone: 227197555

Email: [email protected]

Adrien Switzguebel, MD

Role: CONTACT

Phone: 227197555

Email: [email protected]

Facility Contacts

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Alexandre Lädermann, MD

Role: primary

Other Identifiers

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2016-00818

Identifier Type: -

Identifier Source: org_study_id