Effect of Platelet-rich Fibrin on Rotator Cuff Repair

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01612845

Acronym

PRP-Fibrin

Enrollment

Registered

2012-06-06

Start date

2007-05-31

Completion date

2011-06-30

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears of the Shoulder

Keywords

rotator cuff, shoulder, platelet rich plasma, fibrin

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.

Interventions

PROCEDUREArthroscopic repair without platelet rich fibrin

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

BIOLOGICALPRF (vivostat ®) administration after rotator cuff repair

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI	one year

Secondary

Measure	Time frame
functional outcome evaluated with constant score	two years
disability outcome evaluated with dash score	two years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026