NCT00664794

Brief Summary

Surgical repair of full-thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. However, an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty, but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament. This prospective study examines the hypothesis that appropriate shoulder function can be restored through execution of the traditional arthroscopic cuff repair without acromioplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

4.5 years

First QC Date

January 21, 2008

Last Update Submit

May 14, 2021

Conditions

Shoulder Injuries

Outcome Measures

Primary Outcomes (2)

  • Determine clinical impact by comparing the intervention and control sites for:

    Feb 2008

  • Patient satisfaction

    end of study

Secondary Outcomes (2)

  • Determine sustainability of the impact;

    end of study

  • Accuracy

    end of study

Study Arms (2)

without acromioplasty

ACTIVE COMPARATOR
Procedure: without acromioplasty

with acromioplasty

ACTIVE COMPARATOR
Procedure: with acromioplasty

Interventions

without acromioplastyPROCEDURE

This group will not have their acromion shaved - instead they will receive a repair of their rotator cuff with the scope using sutures or suture anchors.

without acromioplasty
with acromioplastyPROCEDURE

This group will have Their rotator cuff repaired with sutures or suture anchors and additionally will have the tip of their acromion bone shaved slightly.

with acromioplasty

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Diagnosis of full-thickness rotator cuff tear
  • Ability to understand and adhere to rehab protocols and testing procedure
  • Persistent pain and functional disability for at least 6 months and failure of 6 months of conservative treatment

You may not qualify if:

  • Evidence of significant osteoarthritis or cartilage damage in the shoulder
  • Evidence of glenohumeral instability including Bankart lesions and labral tears of any type
  • Previous surgeries of the shoulder
  • Evidence of major joint trauma, infection, or necrosis in the shoulder
  • Patients with partial-thickness tears of the rotator cuff
  • Patients unable to provide informed consent due to language barrier or mental status
  • Patients with a major medical condition that would affect quality of life and influence the results of the study
  • Patients with worker compensation claims
  • Patients unwilling to be followed for the duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pan Am Clinic Foundation

Winnipeg, Manitoba, R3M 3E4, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

  • MacDonald P, McRae S, Leiter J, Mascarenhas R, Lapner P. Arthroscopic rotator cuff repair with and without acromioplasty in the treatment of full-thickness rotator cuff tears: a multicenter, randomized controlled trial. J Bone Joint Surg Am. 2011 Nov 2;93(21):1953-60. doi: 10.2106/JBJS.K.00488.

    PMID: 22048089RESULT

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Peter Lapner, MD

    Ottawa Hospital Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2008

First Posted

April 23, 2008

Study Start

October 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations

CA(2)