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

Rotator Cuff Tear Arthropathy Clinical Trial

Official title:

Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424969
• Other study ID #: 29598
• Status: Completed
• Phase: N/A
• First received: August 22, 2011
• Last updated: February 12, 2014
• Start date: August 2008
• Est. completion date: May 2012

Study information

• Verified date: February 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rotator Cuff Tear Arthropathy

Locations

Country	Name	City	State
United States	University of Utah Orthopedics Center	Salt Lake city	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No