The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair

NCT ID: NCT01424969

Last Updated: 2014-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-05-31

Brief Summary

The purpose of this study was to determine the effect of platelet-rich fibrin matrix (PRFM) augmentation to at-risk arthroscopic rotator cuff repairs on healing rates and functional outcome scores. The investigators performed an observational cohort study in which a consecutive series of patients with rotator cuff tears at risk for retear was prospectively evaluated after arthroscopic repair augmented with PRFM. Clinical and magnetic resonance imaging (MRI) outcomes of the PRFM-augmented repairs were compared with historical controls with similar at-risk tears without PRFM augmentation.

Detailed Description

Increased age, larger tear size, and more advanced fatty degeneration of the rotator cuff musculature have been correlated with poorer healing rates after rotator cuff repair. Platelets are an endogenous source of growth factors present during rotator cuff healing.

The investigators hypothesis is that augmentation of rotator cuff repairs with platelet-rich fibrin matrix (PRFM) may improve the biology of rotator cuff healing and thus improve functional outcome scores and retear rates after repair.

Rotator cuff tears at risk for retear were prospectively identified using an algorithm; points were assigned for age (50-59 years = 1; 60-69 years = 2; .70 years = 3), anterior-to-posterior tear size (2-2.9 cm = 0; 3-3.9 cm = 1; .4 cm = 2), and fatty atrophy (Goutallier score 0-2 = 0; Goutallier score 3-4 = 1). Three points were required for enrollment. Arthroscopic rotator cuff repair was performed with the addition of PRFM. Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores were obtained. Imaging and functional outcomes were compared with historical controls meeting the same enrollment criteria.

Enrollment for the study began in September 2008 and continued until March 2010.

Conditions

Rotator Cuff Tear Arthropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PRFM Group

Patients were selected prospectively for the study based on a 3-part algorithm used to identify rotator cuff tears at risk for retear. A total algorithm score of 3 or greater was required for enrollment in the study.

No interventions assigned to this group

Control Group

The control group were recruited retrospectively. Patients who have undergone arthroscopic repair of rotator cuff tears with similar size characteristics without PRFM augmentation will be encouraged to participate by letter initially, and then by telephone invitation. The same inclusion and exclusion criteria applied. MRI, pain, and functional scores will be collected in the same manner as the PRFM group at one time point at least one year post operatively.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Algorithm score greater and equal to 3
• Both men and women over the age of 50
• Full-thickness rotator cuff tear at least 2 cm in size
• Tear repairable by arthoscopic-only techniques

Exclusion Criteria

• Inflamation joint disease
• Active use of oral steroids
• Irreparable rotator cuff tear
• Subscapularis tear requiring open repair
• Claustrophobia
• Prior rotator cuff sugery on the affected shoulder
• Failure to return for follow-up magnetic resonance imaging scan

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Robert Burks

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Burks, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopedics Center

Locations

University of Utah Orthopedics Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

29598

Identifier Type: -

Identifier Source: org_study_id