Clinical trial NCT01612845: Effect of Platelet-rich Fibrin on Rotator Cuff Repair
Official title: Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rotator Cuff Tears of the Shoulder
Keywords: rotator cuff
shoulder
platelet rich plasma
fibrin
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: spanish society of orthopedics and traumatology
First posted: 2012-06-06
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
timeFrame: one year
Secondary outcomes:
measure: functional outcome evaluated with constant score
timeFrame: two years
measure: disability outcome evaluated with dash score
timeFrame: two years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: H. La PAz
name: Samuel A Antuña, MD PhD
role: STUDY_DIRECTOR
affiliation: HU La PAz
name: Raul Barco, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HU La Paz
name: Jose M Martinez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HU La Paz
name: Jose M sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.