Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

A PROSPECTIVE STUDY TO EVALUATE SURGICAL OUTCOMES IN SUBJECTS WITH FULL-THICKNESS ROTATOR CUFF TEARS TREATED BY MEANS OF A DOUBLE-ROW ARTHROSCOPIC REPAIR.

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff; Arthroscopic Surgery
• Intervention / Treatment: 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
• Enrollment (Actual): 162

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • The CORE Institute
    • Phoenix, Arizona, United States, 85032
      • Paradise Valley Hospital
    • Phoenix, Arizona, United States, 85032
      • Desert Valley Radiology
    • Phoenix, Arizona, United States, 85037
      • Desert Valley Radiology
    • Sun City, Arizona, United States, 85351
      • Banner Boswell Medical Center
    • Sun City, Arizona, United States, 85351
      • The CORE Institute
    • Sun City, Arizona, United States, 85351
      • Banner Boswell Imaging Center
    • Sun City West, Arizona, United States, 85375
      • Banner Del E Webb Medical Center
    • Sun City West, Arizona, United States, 85375
      • Banner Del E Webb Outpatient Diagnostics
    • Sun City West, Arizona, United States, 85375
      • The CORE Institute-Sun City West
  • California
    • San Francisco, California, United States, 94158
      • University of California, San Francisco
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • San Francisco, California, United States, 94115
      • University of California, San Francisco
    • San Francisco, California, United States, 94143-0728
      • University of California, San Francisco
    • San Francisco, California, United States, 94120
      • University of California, San Francisco
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06520
      • Yale-New Haven Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Waltham, Massachusetts, United States, 02451
      • Massachusetts General Hospital
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Rochester, New York, United States, 14618
      • University of Rochester Medical Center
    • Rochester, New York, United States, 14618
      • University Orthopaedic Associates
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • University Orthopedics
    • Providence, Rhode Island, United States, 02906
      • University Orthopedics, Inc.
  • Texas
    • Bedford, Texas, United States, 76021
      • Texas Orthopedic Specialists, PA
    • Grapevine, Texas, United States, 76051
      • Orthopedic Specialists
    • Grapevine, Texas, United States, 76051
      • Preferred Imaging
    • Houston, Texas, United States, 77005
      • Kelsey Research Foundation
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • Houston, Texas, United States, 77025
      • Kelsey Seybold Clinic
    • Houston, Texas, United States, 77014
      • Kelsey-Seybold Spring Medical and Diagnostic Center
    • Southlake, Texas, United States, 76092
      • Harris Methodist Southlake
  • Washington
    • Everett, Washington, United States, 98201
      • The Everett Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community Sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2008
• Primary Completion (Actual): July 5, 2011
• Study Completion (Actual): July 5, 2011

Study Registration Dates

• First Submitted: August 21, 2008
• First Submitted That Met QC Criteria: August 21, 2008
• First Posted (Estimate): August 22, 2008

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: rotator cuff tear; Observational; surgical; arthroscopic; outcome study
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 3202V1-1000; B1861001 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.