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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

162

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach

1 country

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

August 21, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed

2 months until next milestone

Study Start

First participant enrolled

October 13, 2008

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2011

Completed

Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

August 21, 2008

Last Update Submit

February 12, 2021

Conditions

Rotator Cuff Arthroscopic Surgery

Keywords

Observationalrotator cuff teararthroscopicsurgicaloutcome study

Outcome Measures

Primary Outcomes (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.
1 year

Secondary Outcomes (5)

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.
1 year
Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function).
1 year
Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes.
1 year
Evaluation of the ability to define
1 year
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.
1 year

Study Arms (1)

1

Standard of Care

Other: Observational study of the surgical outcome

Interventions

Observational study of the surgical outcomeOTHER

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.

Eligibility Criteria

Age21 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Community Sample

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (37)

The Core Institute

Phoenix, Arizona, 85027, United States

Location

Desert Valley Radiology

Phoenix, Arizona, 85032, United States

Location

Paradise Valley Hospital

Phoenix, Arizona, 85032, United States

Location

Desert Valley Radiology

Phoenix, Arizona, 85037, United States

Location

Banner Boswell Imaging Center

Sun City, Arizona, 85351, United States

Location

Banner Boswell Medical Center

Sun City, Arizona, 85351, United States

Location

The Core Institute

Sun City, Arizona, 85351, United States

Location

Banner Del E Webb Medical Center

Sun City West, Arizona, 85375, United States

Location

Banner Del E Webb Outpatient Diagnostics

Sun City West, Arizona, 85375, United States

Location

The CORE Institute-Sun City West

Sun City West, Arizona, 85375, United States

Location