Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

Not Applicable

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Postoperative early passive motion; Other: Sling

• Registration Number: NCT01502098
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-24
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Status Verified: 2012-01
• Study Start: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-10
• Primary Completion: 2013-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Patients skeletally mature (older 18 years old)
• Small or medium rupture of rotator cuff
• Repaired with arthroscopic double row technique

Exclusion Criteria

• Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants)
• AC arthritis with mumford procedure
• Smokers
• Diabetes
• Postoperative complication (severe pain, thrombosis, infection)
• Psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early passive motion	Postoperative early passive motion	Pendulum exercises starting on the first postoperative day. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises were not permitted until four weeks after surgery.
Immobilization	Sling	Immobilization with sling during a month. Pendulum exercises starting on the fourth postoperative week. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises.

Primary Outcome Measures

Name	Time	Method
MRI	6 months

Secondary Outcome Measures

Name	Time	Method
ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale)	1, 3, 6 months	The ASES is 100-point standardized shoulder-assessment self-report form, 50 points of which are derived from patient self-report of pain on a visual analog scale and 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living derived using a four-point ordinal scale.
Range of Motion	1, 3, 6 months
VAS of pain	1, 3, 6 months	visual analogue scale of pain
WORC	1, 3, 6 months	The Western Ontario Rotator Cuff Index (WORC) is a self-report questionnaire developed specifically to evaluate disability in persons with pathology of the rotator cuff of the shoulder.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina