Supra-spinatus Rehabilitation Program Comparison
This study is currently recruiting participants.
Verified February 2012 by University Hospital, Strasbourg, France
Sponsor:
University Hospital, Strasbourg, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01467336
First received: October 25, 2011
Last updated: February 8, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rotator Cuff Tear |
Procedure: Arthroscopic rotator cuff repair |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair |
Resource links provided by NLM:
Further study details as provided by University Hospital, Strasbourg, France:
| Estimated Enrollment: | 294 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Passive group
Rehabilitation program is immediate. Active range of motion rehabilitation is started at the sixth week.
|
Procedure: Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair for all groups
|
|
Immobilization group
No passive Rehabilitation program is started. An active protocol is started after the sixth week
|
Procedure: Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair for all groups
|
|
Delayed group
Rehabilitation program is delayed to the third week. Active range of motion rehabilitation is started at the sixth week.
|
Procedure: Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair for all groups
|
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467336
Locations
| France | |
| CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg | Recruiting |
| Illkirch, France, 67400 | |
| Contact: Philippe CLAVERT, MD 33.3.88.55.21.51 philippe.clavert@chru-strasbourg.fr | |
| Principal Investigator: Philippe CLAVERT, MD | |
| Sub-Investigator: Jean-François KEMPF, MD | |
| Sub-Investigator: Joseph ARNDT, MD | |
| Centre Chirurgical Emile Gallé | Not yet recruiting |
| Nancy, France, 54052 | |
| Contact: François SIRVEAUX, MD 33.3.83.85.75.00 fsirveaux@sincal-cto.fr | |
| Principal Investigator: François SIRVEAUX, MD | |
| Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy | Not yet recruiting |
| Nancy, France, 54035 | |
| Contact: Alain BLUM, MD 33.3.83.85.18.11 alain.blum@gmail.com | |
| Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg | Recruiting |
| Strasbourg, France, 67098 | |
| Contact: Jean-Claude DOSCH, MD 33.3.88.55.44.16 jean-claude.dosch@chru-strasbourg.fr | |
| Principal Investigator: Jean-Claude DOSCH, MD | |
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
| Principal Investigator: | Philippe CLAVERT, MD | Hôpitaux Universitaires de Strasbourg, France |
More Information
No publications provided
| Responsible Party: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT01467336 History of Changes |
| Other Study ID Numbers: | 4964 |
| Study First Received: | October 25, 2011 |
| Last Updated: | February 8, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
ClinicalTrials.gov processed this record on May 19, 2013