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The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Rupture

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Simple sling.

Neutral brace

About this trial

This is an interventional treatment trial for Rotator Cuff Rupture focused on measuring Rotator cuff, Rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -

Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.

Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.

Sites / Locations

Lovisenberg Diaconal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

3 weeks with simple sling

6 weeks with neutral brace

Arm Description

Early motion after arthroscopic rotator cuff repair.

Delayed motion after arthroscopic rotator cuff repair.

Outcomes

Primary Outcome Measures

We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint

We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group.

Secondary Outcome Measures

Full Information

NCT ID

NCT02050087

First Posted

January 28, 2014

Last Updated

May 30, 2017

Sponsor

Lovisenberg Diakonale Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02050087

Brief Title

The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

Official Title

The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lovisenberg Diakonale Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.

Detailed Description

Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Rupture

Keywords

Rotator cuff, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3 weeks with simple sling

Arm Type

Active Comparator

Arm Description

Early motion after arthroscopic rotator cuff repair.

Arm Title

6 weeks with neutral brace

Arm Type

Active Comparator

Arm Description

Delayed motion after arthroscopic rotator cuff repair.

Intervention Type

Device

Intervention Name(s)

Simple sling.

Intervention Type

Device

Intervention Name(s)

Neutral brace

Primary Outcome Measure Information:

Title

We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint

Description

We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group.

Time Frame

One year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon - Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon. Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sigbjørn Dimmen, MD, Phd

Organizational Affiliation

Lovisenberg Diaconal Hospital, Oslo, Norway

Official's Role

Study Chair

Facility Information:

Facility Name

Lovisenberg Diaconal Hospital

City

Oslo

ZIP/Postal Code

0446

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

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