Early Range of Motion Following Arthroscopic Rotator Cuff Repair

NCT ID: NCT00845715

Last Updated: 2017-04-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a difference in the healing rates between these two groups.

Detailed Description

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Conditions

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Rotator Cuff Disease

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 motion

Group Type OTHER

Early motion

Intervention Type OTHER

Early referral to physical therapy for range of motion (2 days post)

Standard motion

Group Type OTHER

Standard motion

Intervention Type OTHER

Standard referral to physical therapy for range of motion (4 weeks post)

Interventions

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Early motion

Early referral to physical therapy for range of motion (2 days post)

Intervention Type OTHER

Standard motion

Standard referral to physical therapy for range of motion (4 weeks post)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients who are between 18 years and 70 years of age
* full thickness rotator cuff tear on ultrasound and MRI
* failed conservative management

Exclusion Criteria

* concomitant pathology including massive rotator cuff tears that extend into the subscapularis or the teres minor and all co-existing labral pathology
* history of neuromuscular or degenerative disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Donaghue Medical Research Foundation

OTHER

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Augustus Mazzocca

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Augustus D Mazzocca

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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DF08-13

Identifier Type: -

Identifier Source: secondary_id

08-311-3

Identifier Type: -

Identifier Source: org_study_id

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