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

Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of 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.

Study Overview

• Status: Completed
• Conditions: Meniscus Lesion
• Intervention / Treatment: Biological: trephination with placebo; Biological: trephination with platelet rich plasma

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Otwock, Mazowieckie, Poland, 05-400
      • Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: trephination with placebo; meniscal repair with trephination and placebo	Biological: trephination with placebo; trephination under US guidance and placebo injection
Experimental: trephination with platelet rich plasma; meniscal repair with trephination and platelet rich plasma	Biological: trephination with platelet rich plasma; trephination under US guidance and platelet rich plasma injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: platelet rich plasma; meniscus repair
• Other Study ID Numbers: 501-1-07-18-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED