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Trial record 1 of 1 for:    NCT00739947
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Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00739947
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date August 21, 2008
First Posted Date August 22, 2008
Last Update Posted Date July 28, 2014
Study Start Date October 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 16, 2010)
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 ]
Original Primary Outcome Measures
 (submitted: August 21, 2008)
MRI [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures
 (submitted: March 11, 2011)
  • 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 ]
  • Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function). [ Time Frame: 1 year ]
  • Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes. [ Time Frame: 1 year ]
  • Evaluation of the ability to define [ Time Frame: 1 year ]
  • 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 ]
Original Secondary Outcome Measures
 (submitted: August 21, 2008)
Range of Motion and Strength [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
Official Title A Prospective Study To Evaluate Surgical Outcomes In Subjects With Full-Thickness Rotator Cuff Tears Treated By Means Of A Double-Row Arthroscopic Repair
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community Sample
Condition
  • Rotator Cuff
  • Arthroscopic Surgery
Intervention 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.
Study Groups/Cohorts 1
Standard of Care
Intervention: Other: Observational study of the surgical outcome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 19, 2010)
162
Original Estimated Enrollment
 (submitted: August 21, 2008)
160
Actual Study Completion Date July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00739947
Other Study ID Numbers 3202V1-1000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2014