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Completed

NCT Number: NCT01612845

Effect of Platelet-rich Fibrin on Rotator Cuff Repair

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.

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Key information

Conditions

Rotator Cuff Tears of the Shoulder

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario La Paz

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic repair without platelet rich fibrin

Procedure

after the tendon is repaired, no additional procedures are performed and no PRF is administered

PRF (vivostat ®) administration after rotator cuff repair

Biological

7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff

Primary outcomes

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

    Time frame: one year

Secondary outcomes

  1. functional outcome evaluated with constant score

    Time frame: two years

  2. disability outcome evaluated with dash score

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Collaborators

  • spanish society of orthopedics and traumatology

Registry information

Official study title

Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial

Acronym: PRP-Fibrin

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Jun 6, 2012
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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