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Completed

NCT Number: NCT03066583

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

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.

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Key information

Conditions

Meniscus Lesion

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital

Otwock, Masovian Voivodeship, 05-400, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

trephination with placebo

Biological

trephination under US guidance and placebo injection

trephination with platelet rich plasma

Biological

trephination under US guidance and platelet rich plasma injection

Primary outcomes

  1. Assessment of meniscal healing by MR scanning

    Time frame: by 1 year

    The primary outcome measures will be assessment of meniscal healing integrity by MR scanning

Secondary outcomes

  1. Visual Analog Scale

    Time frame: 12 weeks, 6months, 1year post procedure

    Pain Visual Analog Scale.

  2. Knee injury and Osteoarthritis Outcome Score scale

    Time frame: 12 weeks, 6months, 1year post procedure

    Knee injury and Osteoarthritis Outcome Score

  3. International Knee Documentation Committee - Subjective Knee Evaluation Form

    Time frame: 12 weeks, 6months, 1year post procedure

    International Knee Documentation Committee - Subjective Knee Evaluation Form

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

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

Acronym: Prolotherapy

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Feb 28, 2017
Registry last updated
Jun 2, 2020

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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