Clinical trial NCT01424969: The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair
Official title: Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear Arthropathy
Keywords: rotator cuff repair
arthroscopic
platelet-rich plasma
platelet-rich fibrin matrix
outcomes
tendon healing
magnetic resonance imaging
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake city
country: United States
facility: University of Utah Orthopedics Center
state: Utah
Study officials:
affiliation: University of Utah Orthopedics Center
name: Robert Burks, MD
role: PRINCIPAL_INVESTIGATOR
References: