title: Platelet-rich fibrin matrix in the management of arthroscopic repair of the rotator cuff: a prospective, randomized, double-blinded study.
abstract: BACKGROUND
  Arthroscopic rotator cuff repair has a high rate of patient satisfaction. However, multiple studies have shown significant rates of anatomic failure. Biological augmentation would seem to be a reasonable technique to improve clinical outcomes and healing rates.
  
  
  OBJECTIVE
  To represent a prospective, double-blinded, randomized study to assess the use of platelet-rich fibrin matrix (PRFM) in rotator cuff surgery.
  
  
  METHODS
  Randomized controlled trial; level of evidence, 1.
  
  
  METHODS
  Prestudy power analysis demonstrated that a sample size of 30 patients in each group (PRFM vs control) would allow recognition of a 20% difference in perioperative pain scores. Sixty consecutive patients were randomized to either receive a commercially available PRFM product or not. Preoperative and postoperative range of motion (ROM), University of California-Los Angeles (UCLA), and simple shoulder test (SST) scores were recorded. Surgery was performed using an arthroscopic single-row technique. Visual analog scale (VAS) pain scores were obtained upon arrival to the recovery room and 1 hour postoperatively, and narcotic consumption was recorded and converted to standard narcotic equivalents. The SST and ROM measurements were taken at 3, 6, 9, and 12 weeks postoperatively, and final (1 year) American shoulder and elbow surgeons (ASES) shoulder and UCLA shoulder scores were assessed.
  
  
  RESULTS
  There were no complications. Randomization created comparable groups except that the PRFM group was younger than the control group (mean ± SD, 59.67 ± 8.16 y vs 64.50 ± 8.59 y, respectively; P < .05). Mean surgery time was longer for the PRFM group than for the control group (83.28 ± 17.13 min vs 73.28 ± 17.18 min, respectively; P < .02). There was no significant difference in VAS scores or narcotic use between groups and no statistically significant differences in recovery of motion, SST, or ASES scores. Mean ASES scores were 82.48 ± 8.77 (PRFM group) and 82.52 ± 12.45 (controls) (F(1,56) = 0.00, P > .98). Mean UCLA shoulder scores were 27.94 ± 4.98 for the PRFM group versus 29.59 ± 1.68 for the controls (P < .046). Structural results correlated with age and size of the tear and did not differ between the groups.
  
  
  CONCLUSIONS
  Platelet-rich fibrin matrix was not shown to significantly improve perioperative morbidity, clinical outcomes, or structural integrity. While longer term follow-up or different platelet-rich plasma formulations may show differences, early follow-up does not show significant improvement in perioperative morbidity, structural integrity, or clinical outcome.
authors.affiliation: Sacramento Knee and Sports Medicine, 2801 K Street, Suite 310, Sacramento, CA 95816, USA. webersc@earthlink.net
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Weber
authors.forename: Jeffrey I
authors.initials: JI
authors.lastname: Kauffman
authors.forename: Carol
authors.initials: C
authors.lastname: Parise
authors.forename: Sophia J
authors.initials: SJ
authors.lastname: Weber
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Katz
mesh_terms: D000368:Aged; D001182:Arthroscopy; D004311:Double-Blind Method; D005260:Female; D005337:Fibrin; D006801:Humans; D008297:Male; D008875:Middle Aged; D053657:Platelet-Rich Plasma / Q000502:physiology*; D011446:Prospective Studies; D020127:Recovery of Function; D017006:Rotator Cuff / Q000601:surgery*; D000070636:Rotator Cuff Injuries; D013708:Tendon Injuries / Q000601:surgery / Q000628:therapy*; D014945:Wound Healing / Q000502:physiology
chemical_list: D005337:Fibrin