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Effect of Platelet-rich Fibrin on Rotator Cuff Repair (PRP-Fibrin)

Primary Purpose

Rotator Cuff Tears of the Shoulder

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Arthroscopic repair without platelet rich fibrin
PRF (vivostat ®) administration after rotator cuff repair
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears of the Shoulder focused on measuring rotator cuff, shoulder, platelet rich plasma, fibrin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRF

Control

Arm Description

the group in which the PRF was administered

repair without PRF

Outcomes

Primary Outcome Measures

rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI

Secondary Outcome Measures

functional outcome evaluated with constant score
disability outcome evaluated with dash score

Full Information

First Posted
June 4, 2012
Last Updated
June 5, 2012
Sponsor
Hospital Universitario La Paz
Collaborators
spanish society of orthopedics and traumatology
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1. Study Identification

Unique Protocol Identification Number
NCT01612845
Brief Title
Effect of Platelet-rich Fibrin on Rotator Cuff Repair
Acronym
PRP-Fibrin
Official Title
Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz
Collaborators
spanish society of orthopedics and traumatology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears of the Shoulder
Keywords
rotator cuff, shoulder, platelet rich plasma, fibrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRF
Arm Type
Experimental
Arm Description
the group in which the PRF was administered
Arm Title
Control
Arm Type
Active Comparator
Arm Description
repair without PRF
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic repair without platelet rich fibrin
Intervention Description
after the tendon is repaired, no additional procedures are performed and no PRF is administered
Intervention Type
Biological
Intervention Name(s)
PRF (vivostat ®) administration after rotator cuff repair
Intervention Description
7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff
Primary Outcome Measure Information:
Title
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
Time Frame
one year
Secondary Outcome Measure Information:
Title
functional outcome evaluated with constant score
Time Frame
two years
Title
disability outcome evaluated with dash score
Time Frame
two years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel A Antuña, MD PhD
Organizational Affiliation
H. La PAz
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raul Barco, MD PhD
Organizational Affiliation
HU La PAz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose M Martinez, MD
Organizational Affiliation
HU La Paz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose M sanchez, MD
Organizational Affiliation
HU La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21737832
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.
Results Reference
background
PubMed Identifier
21570659
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.
Results Reference
background
PubMed Identifier
21160018
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.
Results Reference
background
PubMed Identifier
21802625
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.
Results Reference
result

Learn more about this trial

Effect of Platelet-rich Fibrin on Rotator Cuff Repair

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