CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 189 enrolled
Drug / intervention
Sling +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01741272
NCT01741272Phase 4Completed

Early Mobilization Following Mini-Open Rotator Cuff Repair: A Randomized Clinical Trial

University of Alberta·interventional·Posted Dec 4, 2012·Updated Oct 28, 2021

In Brief

A Phase 4 clinical trial evaluating Sling and No sling for Full Thickness Rotator Cuff Tears. Completed, enrolled 189 participants across 1 site.

Detailed Summary

The primary objective of this study is to determine if early active range of motion after mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6 weeks and 3 months after surgery. The secondary objective of this study is to determine if early mobilization improves disease-specific quality of life and promotes earlier return to work/function. Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of range of motion, improved disease specific quality of life and earlier return to work/function if allowed to begin early active range of motion compared to subjects who are immobilized in a sling for 6 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 4, 2012
Enrollment StartSep 1, 2003
Primary CompletionJan 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 13.6 years ago

Interventions

Slingprocedure

Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.

No slingprocedure

Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.