- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612845
Effect of Platelet-rich Fibrin on Rotator Cuff Repair (PRP-Fibrin)
June 5, 2012 updated by: Samuel Antuna, Hospital Universitario La Paz
Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28046
- Hospital Universitario La Paz
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PRF
the group in which the PRF was administered
|
7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff
|
Active Comparator: Control
repair without PRF
|
after the tendon is repaired, no additional procedures are performed and no PRF is administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
functional outcome evaluated with constant score
Time Frame: two years
|
two years
|
disability outcome evaluated with dash score
Time Frame: two years
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Samuel A Antuña, MD PhD, H. La Paz
- Principal Investigator: Raul Barco, MD PhD, Hu La Paz
- Principal Investigator: Jose M Martinez, MD, Hu La Paz
- Principal Investigator: Jose M sanchez, MD, Hu La Paz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 4, 2012
First Submitted That Met QC Criteria
June 5, 2012
First Posted (Estimate)
June 6, 2012
Study Record Updates
Last Update Posted (Estimate)
June 6, 2012
Last Update Submitted That Met QC Criteria
June 5, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI-523
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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