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: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Rotator Cuff
Arthroscopic Surgery
Other: Observational study of the surgical outcome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 162
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Standard of Care
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community Sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739947

Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85027
Pfizer Investigational Site
Sun City West, Arizona, United States, 85375
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94158
Pfizer Investigational Site
San Francisco, California, United States, 94143-0728
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02905
United States, Texas
Pfizer Investigational Site
Grapevine, Texas, United States, 76051
Pfizer Investigational Site
Houston, Texas, United States, 77025
United States, Washington
Pfizer Investigational Site
Everett, Washington, United States, 98201
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00739947     History of Changes
Other Study ID Numbers: 3202V1-1000
Study First Received: August 21, 2008
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Observational
rotator cuff tear
arthroscopic
surgical
outcome study

ClinicalTrials.gov processed this record on August 26, 2014