Supra-spinatus Rehabilitation Program Comparison

Rotator Cuff Tear Clinical Trial

Official title:

Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01467336
• Other study ID #: 4964
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2011
• Last updated: February 8, 2012
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2012
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Procedure:
• Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair for all groups

Locations

Country	Name	City	State
France	CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg	Illkirch
France	Centre Chirurgical Emile Gallé	Nancy
France	Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy	Nancy
France	Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France,