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

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ClinicalTrials.gov Identifier: NCT01612845
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : June 6, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears of the Shoulder Procedure: Arthroscopic repair without platelet rich fibrin Biological: PRF (vivostat ®) administration after rotator cuff repair Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial
Study Start Date : May 2007
Primary Completion Date : May 2009
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PRF
the group in which the PRF was 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
Active Comparator: Control
repair without PRF
Procedure: Arthroscopic repair without platelet rich fibrin
after the tendon is repaired, no additional procedures are performed and no PRF is administered


Outcome Measures

Primary Outcome Measures :
  1. rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI [ Time Frame: one year ]

Secondary Outcome Measures :
  1. functional outcome evaluated with constant score [ Time Frame: two years ]
  2. disability outcome evaluated with dash score [ Time Frame: two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612845


Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Universitario La Paz
spanish society of orthopedics and traumatology
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
More Information

Publications:
Responsible Party: Samuel Antuna, Consultant in Shoulder and Elbow Surgery, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01612845     History of Changes
Other Study ID Numbers: PI-523
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Samuel Antuna, Hospital Universitario La Paz:
rotator cuff
shoulder
platelet rich plasma
fibrin

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries