Effectiveness of Trephination With Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment

Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03066583

Acronym

Prolotherapy

Enrollment

Registered

2017-02-28

Start date

2016-01-31

Completion date

2020-06-30

Last updated

2020-06-02

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

Conditions

Meniscus Lesion

Keywords

meniscus repair, platelet rich plasma

Brief summary

This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may improve meniscal healing rates.

Detailed description

The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.

Interventions

BIOLOGICALtrephination with placebo

trephination under US guidance and placebo injection

BIOLOGICALtrephination with platelet rich plasma

trephination under US guidance and platelet rich plasma injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Complete horizontal 10 mm in length * Tear located in the vascular/avascular portion of the meniscus (chronic horizontal tear on MR) * Single tear of the medial and/or lateral meniscus * Skeletally mature patients 18-70 years of age

Exclusion criteria

* discoid meniscus * arthritic changes (Kellgren Lawrence scale \>2) or axial leg deformity (valgus \> 6 deg) * inflammatory diseases (i.e. rheumatoid arthritis) * concominant chondral defects (\> 2 ICRS)

Design outcomes

Primary

Measure	Time frame	Description
Assessment of meniscal healing by MR scanning	by 1 year	The primary outcome measures will be assessment of meniscal healing integrity by MR scanning

Secondary

Measure	Time frame	Description
Visual Analog Scale	12 weeks, 6months, 1year post procedure	Pain Visual Analog Scale.
Knee injury and Osteoarthritis Outcome Score scale	12 weeks, 6months, 1year post procedure	Knee injury and Osteoarthritis Outcome Score
International Knee Documentation Committee - Subjective Knee Evaluation Form	12 weeks, 6months, 1year post procedure	International Knee Documentation Committee - Subjective Knee Evaluation Form

Countries

Poland

Outcome results

None listed

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