Trial Outcomes & Findings for Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty (NCT NCT00290888)

NCT ID: NCT00290888

Last Updated: 2015-03-27

Results Overview

Calculated as percentage with an increase in score indicating an improvement in outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2015-03-27

Participant Flow

A total of 86 patients were randomized to either ACR-A or ACR

Participant milestones

Measure	Arthroscopic Rotator Cuff Repair Without Acromioplasty ACR Acromioplasty	Arthorscopic Rotator Cuff Repair With Acromioplasty ACR-A Acromioplasty
Overall Study STARTED	41	45
Overall Study COMPLETED	38	44
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Arthroscopic Rotator Cuff Repair Without Acromioplasty ACR Acromioplasty	Arthorscopic Rotator Cuff Repair With Acromioplasty ACR-A Acromioplasty
Overall Study Physician Decision	3	1

Baseline Characteristics

Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty

Baseline characteristics by cohort

Measure	Arthroscopic Rotator Cuff Repair Without Acromioplasty n=41 Participants Arthroscopic rotator cuff repair without acromioplasty (ACR)	Arthroscopic Rotator Cuff Repair With Acromioplasty n=45 Participants Arthroscopic rotator cuff repair with acromioplasty (ACR-A)	Total n=86 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 9.5 • n=5 Participants	56.2 years STANDARD_DEVIATION 7.9 • n=7 Participants	56.7 years STANDARD_DEVIATION 8.7 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	45 Participants n=7 Participants	86 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Female	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Gender Male	30 participants n=5 Participants	24 participants n=7 Participants	54 participants n=5 Participants
Region of Enrollment Canada	41 participants n=5 Participants	45 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Calculated as percentage with an increase in score indicating an improvement in outcome.

Outcome measures

Measure	Arthroscopic Rotator Cuff Repair Without Acromioplasty n=38 Participants ACR	Arthroscopic Rotator Cuff Repair With Acromioplasty n=44 Participants ACR-A Acromioplasty
Western Ontario Rotator Cuff Index (WORC)	80.5 percentage of total score Standard Deviation 22.3	86.7 percentage of total score Standard Deviation 16.2

PRIMARY outcome

Timeframe: 24 months

Calculated as a percentage with an increase in score reflecting an improvement in outcome.

Outcome measures

Measure	Arthroscopic Rotator Cuff Repair Without Acromioplasty n=38 Participants ACR	Arthroscopic Rotator Cuff Repair With Acromioplasty n=44 Participants ACR-A Acromioplasty
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)	84.6 percentage of total score Standard Deviation 20.1	89.8 percentage of total score Standard Deviation 14.4

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

Adverse Events

Arthroscopic Rotator Cuff Repair Without Acromioplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arthroscopic Rotator Cuff Repair With Acromioplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter MacDonald

Pan Am Clinic

Phone: 204-925-7480

Email: pmacdonald@panamclinic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place