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Post-op Rehabilitation's Influence on Tendon Healing & Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

NCT00756015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-10-16

No results posted yet for this study

Summary

The purpose of this study is to better understand the influence of post-operative rehabilitation on the rate of tendon healing and clinical outcomes following arthroscopic repair of the rotator cuff. There are two schools of thought on what type of therapy program is most beneficial following surgical cuff repair. However there has been little data available to compare them. Therefore, the investigators would like to compare these two standard plans of care so that the investigators may better define the safety and efficacy of early mobilization of the shoulder versus keeping the shoulder immobilized following surgical management.

Conditions

  • Rotator Cuff Tear

Interventions

OTHER

Early Motion Protocol

Early range of motion group: Shoulder pendulum exercises will be allowed from the time of surgery. Immediate range of motion of the elbow, forearm, wrist and hand. At the first postoperative visit, PROM of the shoulder will be permitted under therapist direction. Patients will avoid IR and behind the back stretching. At 6 weeks, AAROM and AROM will be advanced as tolerated. Capsular stretching will be advanced until full range of motion is achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 3 months post surgery.

OTHER

Immobilization

Immobilization group: 6 weeks of sling shoulder immobilization. Immediate range of motion of the elbow, forearm, wrist and hand. At 6 weeks, PROM and stretching of the shoulder allowed under therapist direction. At 12 weeks, AAROM and AROM exercises will be initiated and capsular stretching advanced until full ROM achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers will be permitted at 4 months post surgery.

Sponsors & Collaborators

  • Barnes-Jewish Hospital

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jay Keener, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00756015 on ClinicalTrials.gov