Supra-spinatus Rehabilitation Program Comparison

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by University Hospital, Strasbourg, France
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014