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

NCT01424969 | Completed

• 1 other identifier: 29598
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear Arthropathy

Keywords

rotator cuff repair; arthroscopic; platelet-rich plasma; platelet-rich fibrin matrix; outcomes; tendon healing; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores

  Patients with symptomatic rotator cuff tears identified by clinical exam and MRI that measure greater than two centimeters or are retracted medially to the level of the humeral head cartilage. Shoulder pain scores, functional scores, and MRI data will be obtained pre-operatively and compared to the same data collected 1 year post-operatively.

  1 year

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic rotator cuff tears identified by clinical exam and MRI that measure greater than two centimeters or are retracted medially to the level of the humeral head cartilage that meet the inclusion/exclusion criteria were asked to participate.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Officials

• Robert Burks, MD

  University of Utah Orthopedics Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 29, 2011
• Study Start: August 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (1)