Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-13

Study Completion Date

2011-07-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rotator Cuff Arthroscopic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Standard of Care

Observational study of the surgical outcome

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The Core Institute

Phoenix, Arizona, United States

Site Status

Desert Valley Radiology

Phoenix, Arizona, United States

Site Status

Paradise Valley Hospital

Phoenix, Arizona, United States

Site Status

Desert Valley Radiology

Phoenix, Arizona, United States

Site Status

Banner Boswell Imaging Center

Sun City, Arizona, United States

Site Status

Banner Boswell Medical Center

Sun City, Arizona, United States

Site Status

The Core Institute

Sun City, Arizona, United States

Site Status

Banner Del E Webb Medical Center

Sun City West, Arizona, United States

Site Status

Banner Del E Webb Outpatient Diagnostics

Sun City West, Arizona, United States

Site Status