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Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00739947
First received: August 21, 2008
Last updated: April 12, 2012
Last verified: April 2012
History of Changes

August 21, 2008
April 12, 2012
October 2008
July 2011   (final data collection date for primary outcome measure)
The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00739947 on ClinicalTrials.gov Archive Site
  • Determine the correlation of functional outcomes over time in subjects with retears compared with subjects who have an intact cuff repair using the Constant Murley Shoulder Score as well as strength and range of motion. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluation of the ability to define [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Observation of any comorbidity associated with the arthroscopic surgical procedure through the collection of adverse events to provide and SOC reference for future safety studies. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Range of Motion and Strength [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
A Prospective Study To Evaluate Surgical Outcomes In Subjects With Full-Thickness Rotator Cuff Tears Treated By Means Of A Double-Row Arthroscopic Repair

This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.

Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Community Sample
  • Rotator Cuff
  • Arthroscopic Surgery
Other: Observational study of the surgical outcome
Subjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound.
1
Standard of Care
Intervention: Other: Observational study of the surgical outcome
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size.
  • Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy

Exclusion Criteria:

  • Previous surgical intervention to the shoulder joint understudy
  • Tears of the subscapularis or labral pathology requiring surgical repair
  • Shoulder instability either shoulder
  • Unable to complete functional evaluations in either shoulder
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739947
3202V1-1000
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP