Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

NCT ID: NCT01502098

Last Updated: 2012-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Postoperative early passive motion

Intervention Type PROCEDURE

Shoulder exercises starting on the first postoperative day

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.

Group Type NO_INTERVENTION

Sling

Intervention Type OTHER

Sling for 4 weeks

Interventions

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Postoperative early passive motion

Shoulder exercises starting on the first postoperative day

Intervention Type PROCEDURE

Sling

Sling for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Lopez Ovenza Juan Manuel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Juan M. Lopez Ovenza, MD

Role: CONTACT

15-5-9249686

Facility Contacts

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Juan Manuel Lopez Ovenza, MD

Role: primary

Other Identifiers

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CEPI:1780

Identifier Type: -

Identifier Source: org_study_id

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