Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

Pfizer

Status: Completed

Conditions: Arthroscopic Surgery; Rotator Cuff

Treatments: Other: Observational study of the surgical outcome

Study type: Observational

Funder types: Industry

Identifiers

NCT00739947

B1861001 (Other Identifier)

3202V1-1000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

162 participants in 1 patient group

1

Description:

Standard of Care

Treatment:

Other: Observational study of the surgical outcome