Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128076
Status:
COMPLETED
Last Update Posted:
2016-05-27
First Post:
2005-08-05
Brief Title:
All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare two different surgical techniques for repairing a tear in the muscles of the shoulder rotator cuff The investigators will determine whether an arthroscopic or mini-open technique provides better quality of life and repair integrity
Detailed Description:
Background
Rotator cuff tears are the most common source of shoulder pain and disability Only poor quality studies have compared mini-open to arthroscopic repair leaving surgeons with inadequate evidence to support optimal minimally-invasive repair
MethodsDesign
This randomized multi-centre national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate sized rotator cuff tears A national consensus meeting of investigators in Joints Orthopaedic Initiative for Shoulder Trials JOINTS identified this question as the top priority for shoulder surgeons across Canada The primary outcome measure is a valid quality-of-life scale Western Ontario Rotator Cuff WORC that addresses 5 domains of health affected by rotator cuff disease Secondary outcomes will assess rotator cuff functionality ROM strength constant score secondary dimensions of health general health status SF-12 and work limitations and repair integrity MRI Outcomes are measured at baseline at 6 weeks 3 6 12 and 24 months postoperatively by blinded research assistants and musculoskeletal radiologists Patients n250 with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited This sample size will provide 80 power to detect statistically a clinically important difference of 20 in WORC scores between procedures after controlling for baseline WORC score 005 A central methods centre will manage randomization data management and monitoring under supervision of experienced epidemiologists Surgeons will participate in either conventional or expertise-based designs according to defined criteria to avoid biases from differential surgeon expertise Mini-open or all-arthroscopic repair procedures will be performed according to a standardized protocol Central Adjudication of cases Trial Oversight and Safety Committees will monitor trial conduct The investigators will use an analysis of covariance ANCOVA where the baseline WORC score is used as a covariate to compare the quality of life WORC score at 2-years post-operatively As a secondary analysis the investigators will conduct the same statistical test but will include age and tear size as covariates with the baseline score Enrollment will require 2 years and follow-up an additional 2-years
Rotator cuff tears are the most common source of shoulder pain and disability Only poor quality studies have compared mini-open to arthroscopic repair leaving surgeons with inadequate evidence to support optimal minimally-invasive repair
MethodsDesign
This randomized multi-centre national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate sized rotator cuff tears A national consensus meeting of investigators in Joints Orthopaedic Initiative for Shoulder Trials JOINTS identified this question as the top priority for shoulder surgeons across Canada The primary outcome measure is a valid quality-of-life scale Western Ontario Rotator Cuff WORC that addresses 5 domains of health affected by rotator cuff disease Secondary outcomes will assess rotator cuff functionality ROM strength constant score secondary dimensions of health general health status SF-12 and work limitations and repair integrity MRI Outcomes are measured at baseline at 6 weeks 3 6 12 and 24 months postoperatively by blinded research assistants and musculoskeletal radiologists Patients n250 with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited This sample size will provide 80 power to detect statistically a clinically important difference of 20 in WORC scores between procedures after controlling for baseline WORC score 005 A central methods centre will manage randomization data management and monitoring under supervision of experienced epidemiologists Surgeons will participate in either conventional or expertise-based designs according to defined criteria to avoid biases from differential surgeon expertise Mini-open or all-arthroscopic repair procedures will be performed according to a standardized protocol Central Adjudication of cases Trial Oversight and Safety Committees will monitor trial conduct The investigators will use an analysis of covariance ANCOVA where the baseline WORC score is used as a covariate to compare the quality of life WORC score at 2-years post-operatively As a secondary analysis the investigators will conduct the same statistical test but will include age and tear size as covariates with the baseline score Enrollment will require 2 years and follow-up an additional 2-years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None