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

NCT00756015 | Completed

• 1 other identifier: HRPO 07-0915
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rotator cuff; post-operative immobilization protocol; post-operative early motion protocol; physical therapy; cuff repair integrity; ultrasound

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation of Shoulder function and strength

  3 months, 6 months, 1 year and 2 years post op

Secondary Outcomes (1)

• Evaluation of cuff repair integrity using Ultrasound at 1 year post op

  1 year post op

Study Arms (2)

Early Motion

ACTIVE COMPARATOR

Other: Early range of motion post-operative therapy 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: Early Motion Protocol

Immobilization

OTHER

Immobilization following rotator cuff repair.

Other: Immobilization

Interventions

Early Motion Protocol OTHER

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.

Also known as: physical therapy, early mobilization

Early Motion

Immobilization OTHER

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.

Also known as: Sling, Delayed active range of motion

Immobilization

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Full-thickness tears of the rotator cuff involving the supraspinatus that may or may not include the infraspinatus tendon (less than 25 mm anteroposterior dimension)
• Arthroscopic double-row cuff repair

You may not qualify if:

• Acute rotator cuff tears less than 6 weeks from injury
• Subscapularis tendon tears (full thickness)
• Preoperative stiffness: loss of greater than 30 passive elevation and/or ER compared to the opposite shoulder
• Inability to comply with postoperative rehabilitation protocols
• Inflammatory disease
• Prior surgery of the shoulder

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine - Department of Orthopedics

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Physical Therapy Modalities; Early Ambulation; Immobilization; Suburethral Slings

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Study Officials

• Jay Keener, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Orthopaedic Surgery

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 19, 2008
• Study Start: November 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)