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. Identifier: NCT00739947
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : July 28, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Rotator Cuff Arthroscopic Surgery Other: Observational study of the surgical outcome

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
Actual Enrollment : 162 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function). [ Time Frame: 1 year ]
  3. Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes. [ Time Frame: 1 year ]
  4. Evaluation of the ability to define [ Time Frame: 1 year ]
  5. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00739947

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, 94143-0728
Pfizer Investigational Site
San Francisco, California, United States, 94158
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, 10021
Pfizer Investigational Site
New York, New York, United States, 10029
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
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT00739947     History of Changes
Other Study ID Numbers: 3202V1-1000
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Pfizer:
rotator cuff tear
outcome study

Additional relevant MeSH terms:
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries