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Effect of Platelet-rich Fibrin on Rotator Cuff Repair

NCT01612845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-06-06

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tears of the Shoulder

Interventions

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

Sponsors & Collaborators

  • spanish society of orthopedics and traumatology

    collaborator UNKNOWN

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Samuel A Antuña, MD PhD · H. La PAz

  • Raul Barco, MD PhD · HU La PAz

  • Jose M Martinez, MD · HU La Paz

  • Jose M sanchez, MD · HU La Paz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-05-31
Completion
2011-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01612845 on ClinicalTrials.gov