Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

Sponsor

Hospital Italiano de Buenos Aires (Other)

Overall Status

Unknown status

CT.gov ID

NCT01502098

Collaborator

(none)

114

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear	Procedure: Postoperative early passive motion Other: Sling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Postoperative early passive motion Shoulder exercises starting on the first postoperative day
No Intervention: Immobilization 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.	Other: Sling Sling for 4 weeks

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: Postoperative early passive motion

Shoulder exercises starting on the first postoperative day

No Intervention: Immobilization

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.

Other: Sling

Sling for 4 weeks

Outcome Measures

Primary Outcome Measures

MRI [6 months]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Italiano de Buenos Aires	Buenos Aires		Argentina	1118

Sponsors and Collaborators

Hospital Italiano de Buenos Aires

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lopez Ovenza Juan Manuel, Principal Investigator, Hospital Italiano de Buenos Aires

ClinicalTrials.gov Identifier:

NCT01502098

Other Study ID Numbers:

CEPI:1780

First Posted:

Dec 30, 2011

Last Update Posted:

Jan 10, 2012

Last Verified:

Jan 1, 2012

Additional relevant MeSH terms:

Rotator Cuff Injuries

Study Results

No Results Posted as of Jan 10, 2012