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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

About this trial

This is an interventional supportive care trial for Rotator Cuff Tear

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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

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

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

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