Effect of Platelet-rich Fibrin on Rotator Cuff Repair

Rotator Cuff Tears of the Shoulder Clinical Trial

— PRP-Fibrin  

Official title:

Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612845
• Other study ID #: PI-523
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2012
• Last updated: June 5, 2012
• Start date: May 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2011
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tears of the Shoulder

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario La Paz	spanish society of orthopedics and traumatology

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Barber FA, Hrnack SA, Snyder SJ, Hapa O. Rotator cuff repair healing influenced by platelet-rich plasma construct augmentation. Arthroscopy. 2011 Aug;27(8):1029-35. doi: 10.1016/j.arthro.2011.06.010. — View Citation

Castricini R, Longo UG, De Benedetto M, Panfoli N, Pirani P, Zini R, Maffulli N, Denaro V. Platelet-rich plasma augmentation for arthroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. doi: 10.1177/0363546510390780. Epub 2010 Dec 15. — View Citation

Jo CH, Kim JE, Yoon KS, Lee JH, Kang SB, Lee JH, Han HS, Rhee SH, Shin S. Does platelet-rich plasma accelerate recovery after rotator cuff repair? A prospective cohort study. Am J Sports Med. 2011 Oct;39(10):2082-90. doi: 10.1177/0363546511413454. Epub 2011 Jul 7. — View Citation

Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI		one year	No
Secondary	functional outcome evaluated with constant score		two years	No
Secondary	disability outcome evaluated with dash score		two years	No