NCT00845715

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

February 13, 2009

Last Update Submit

April 24, 2017

Conditions

Rotator Cuff Disease

Keywords

rotator cuffrehabilitationrange of motion

Outcome Measures

Primary Outcomes (1)

  • Western Ontario Rotator Cuff Index (WORC)

    6 month post surgery

Study Arms (2)

Early motion

OTHER
Other: Early motion

Standard motion

OTHER
Other: Standard motion

Interventions

Early motionOTHER

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

Early motion
Standard motionOTHER

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

Standard motion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Study Officials

  • Augustus D Mazzocca

    UConn Health

    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
Professor

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 18, 2009

Study Start

July 1, 2008

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

US(1)