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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Burks, University of Utah
ClinicalTrials.gov Identifier:
NCT01424969
First received: August 22, 2011
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition
Rotator Cuff Tear Arthropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: August 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424969

Locations
United States, Utah
University of Utah Orthopedics Center
Salt Lake city, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Robert Burks, MD University of Utah Orthopedics Center
  More Information

No publications provided

Responsible Party: Robert Burks, MD, University of Utah
ClinicalTrials.gov Identifier: NCT01424969     History of Changes
Other Study ID Numbers: 29598
Study First Received: August 22, 2011
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
rotator cuff repair
arthroscopic
platelet-rich plasma
platelet-rich fibrin matrix
outcomes
tendon healing
magnetic resonance imaging

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014