Supra-spinatus Rehabilitation Program Comparison | NCT01467336

Studies
Supra-spinatus Rehabilitation Program Comparison

NCT01467336

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Nov 24, 2025Actual

Enrollment

229Actual

Phase

Not Applicable

Conditions

Rotator Cuff Tear

Interventions

Arthroscopic rotator cuff repair

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Patient inclusion stopped since 2019

Expanded Access Info

Start Date

Jan 9, 2012Actual

Primary Completion Date

Feb 2020Actual

Completion Date

Feb 2020Actual

First Submitted Date

Oct 25, 2011

First Submission Date that Met QC Criteria

Nov 3, 2011

First Posted Date

Nov 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2025

Last Update Posted Date

Nov 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Through a prospective randomized study the aims of this study is to analyze the impact of 3 types of rehabilitation protocols on the Optimization of the post-operative clinical and anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2 supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group):

strict immobilization for 6 weeks then active rehabilitation,
or 3 weeks of immobilization then 3 weeks of passive motion before active rehabilitation,
or immediate passive motion for 6 weeks and then active rehabilitation.

Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an arthro-CT will be performed at 1 year.

The investigators will evaluate: constant score and rate of tendon healing.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

229Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Passive group	Other	Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week.	Procedure: Arthroscopic rotator cuff repair
Immobilization group	Other	No passive Rehabilitation program is started. An active protocol is started after the sixth week	Procedure: Arthroscopic rotator cuff repair
Delayed group	Other	Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week.	Procedure: Arthroscopic rotator cuff repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arthroscopic rotator cuff repair	Procedure	Arthroscopic rotator cuff repair for all groups	Delayed group Immobilization group Passive group

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female between 40 and 65 years old
non-retracted supra-spinatus tendon tear-pre-operative clinical examination and ct
scan-arthroscopic single-row tendon repair

Exclusion Criteria:

patient with a stiff shoulder
previous surgery of the shoulder
stage 3 or 4 fatty infiltration
insufficient repair of the cuff

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe CLAVERT, MD	Hôpitaux Universitaires de Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy		Nancy		54035	France
Centre Chirurgical Emile Gallé

Condition Browse Module

MeSH Terms

ID	Term
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries

Browse Leaves

Not provided

Browse Branches

Not provided