Trial | NCT01612845  Report issue

Title

Effect of Platelet-rich Fibrin on Rotator Cuff Repair
Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vivostat ...

  • Study Participants

    28
The objective of this study was to prospectively evaluate the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff.
A prospective, randomized clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range, 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. In 14 patients, after the repair was completed, 6 cc. of PRF (vivostat ®) were locally applied to the repair site. In 14 patients no addition of PRF was performed. All patients underwent an arthro-MRI to evaluate the integrity of the repair and a clinical exam one year after the operation. All patients were then followed clinically at a minimum of 2 years. Functional outcome was evaluated with the Constant and DASH scores.
Study Started
May 31
2007
Primary Completion
May 31
2009
Study Completion
Jun 30
2011
Last Update
Jun 06
2012
Estimate

Procedure Arthroscopic repair without platelet rich fibrin

after the tendon is repaired, no additional procedures are performed and no PRF is administered

Biological PRF (vivostat ®) administration after rotator cuff repair

7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff

PRF Experimental

the group in which the PRF was administered

Control Active Comparator

repair without PRF

Criteria 

Inclusion Criteria:

Massive rotator cuff tears affecting supraspinatus and infraspinatus
Failed conservative treatment for at least 6 months
No hematologic disorder

Exclusion Criteria:

Rotator cuff affecting subscapularis
chronic infectious disease
anemia
clot disorders
low platelet count
history of difficulty in venous puncture
No Results Posted