NCT02050087

Brief Summary

The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

January 28, 2014

Last Update Submit

May 30, 2017

Conditions

Rotator Cuff Rupture

Keywords

Rotator cuffRehabilitation

Outcome Measures

Primary Outcomes (1)

  • We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint

    We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group.

    One year

Study Arms (2)

3 weeks with simple sling

ACTIVE COMPARATOR

Early motion after arthroscopic rotator cuff repair.

Device: Neutral brace

6 weeks with neutral brace

ACTIVE COMPARATOR

Delayed motion after arthroscopic rotator cuff repair.

Device: Simple sling.

Interventions

Simple sling.DEVICE
6 weeks with neutral brace
Neutral braceDEVICE
3 weeks with simple sling

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration \>grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diaconal Hospital

Oslo, 0446, Norway

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Sigbjørn Dimmen, MD, Phd

    Lovisenberg Diaconal Hospital, Oslo, Norway

    STUDY CHAIR

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
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Study Completion

January 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

NO(1)