Supra-spinatus Rehabilitation Program Comparison
Primary Purpose
Rotator Cuff Tear
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arthroscopic rotator cuff repair
Sponsored by
About this trial
This is an interventional supportive care trial for Rotator Cuff Tear
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
Sites / Locations
- CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de StrasbourgRecruiting
- Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy
- Centre Chirurgical Emile Gallé
- Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Passive group
Immobilization group
Delayed group
Arm Description
Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week.
No passive Rehabilitation program is started. An active protocol is started after the sixth week
Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01467336
First Posted
October 25, 2011
Last Updated
February 8, 2012
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01467336
Brief Title
Supra-spinatus Rehabilitation Program Comparison
Official Title
Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
294 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Passive group
Arm Type
Other
Arm Description
Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week.
Arm Title
Immobilization group
Arm Type
Other
Arm Description
No passive Rehabilitation program is started. An active protocol is started after the sixth week
Arm Title
Delayed group
Arm Type
Other
Arm Description
Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic rotator cuff repair
Intervention Description
Arthroscopic rotator cuff repair for all groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe CLAVERT, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg
City
Illkirch
ZIP/Postal Code
67400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe CLAVERT, MD
Phone
33.3.88.55.21.51
Email
philippe.clavert@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Philippe CLAVERT, MD
First Name & Middle Initial & Last Name & Degree
Jean-François KEMPF, MD
First Name & Middle Initial & Last Name & Degree
Joseph ARNDT, MD
Facility Name
Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain BLUM, MD
Phone
33.3.83.85.18.11
Email
alain.blum@gmail.com
Facility Name
Centre Chirurgical Emile Gallé
City
Nancy
ZIP/Postal Code
54052
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François SIRVEAUX, MD
Phone
33.3.83.85.75.00
Email
fsirveaux@sincal-cto.fr
First Name & Middle Initial & Last Name & Degree
François SIRVEAUX, MD
Facility Name
Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Claude DOSCH, MD
Phone
33.3.88.55.44.16
Email
jean-claude.dosch@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Jean-Claude DOSCH, MD
12. IPD Sharing Statement
Learn more about this trial
Supra-spinatus Rehabilitation Program Comparison
We'll reach out to this number within 24 hrs