Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

NCT00739947

Last updated date
Study Location
The Core Institute
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. Phoenix, Arizona
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  4. Phoenix, Arizona
  5. Sun City West, Arizona
  6. Sun City West, Arizona
  7. Sun City West, Arizona
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  9. Sun City, Arizona
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  11. San Francisco, California
  12. San Francisco, California
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  16. New Haven, Connecticut
  17. New Haven, Connecticut
  18. Boston, Massachusetts
  19. Waltham, Massachusetts
  20. New York, New York
  21. New York, New York
  22. Rochester, New York
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  24. Rochester, New York
  25. Cleveland, Ohio
  26. Cleveland, Ohio
  27. Providence, Rhode Island
  28. Providence, Rhode Island
  29. Bedford, Texas
  30. Grapevine, Texas
  31. Grapevine, Texas
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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 5, 2011
Actual Primary Completion Date July 5, 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
B1861001 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2021