Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

NCT00739947

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85027, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rotator Cuff, Arthroscopic Surgery
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Rotator Cuff, Arthroscopic SurgeryArthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears NCT00739947
  1. Phoenix, Arizona
  2. Sun City West, Arizona
  3. San Francisco, California
  4. San Francisco, California
  5. New Haven, Connecticut
  6. Boston, Massachusetts
  7. New York, New York
  8. New York, New York
  9. Rochester, New York
  10. Cleveland, Ohio
  11. Providence, Rhode Island
  12. Grapevine, Texas
  13. Houston, Texas
  14. Everett, Washington
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
PRS Account Pfizer
Verification Date July 2014