Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00739947
First received: August 21, 2008
Last updated: April 12, 2012
Last verified: April 2012
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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 | Phase |
|---|---|---|
|
Rotator Cuff Arthroscopic Surgery |
Other: Observational study of the surgical outcome |
Phase 1 |
| 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
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: | April 12, 2012 |
| 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 May 23, 2013