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

NCT03066583 | Completed Phase 2 DMC

• 1 other identifier: 501-1-07-18-15
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Lesion

Keywords

meniscus repair; platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual Analog Scale

  12 weeks, 6months, 1year post procedure

• Knee injury and Osteoarthritis Outcome Score scale

  12 weeks, 6months, 1year post procedure

• International Knee Documentation Committee - Subjective Knee Evaluation Form

  12 weeks, 6months, 1year post procedure

Study Arms (2)

trephination with placebo

PLACEBO COMPARATOR

meniscal repair with trephination and placebo

Biological: trephination with placebo

trephination with platelet rich plasma

EXPERIMENTAL

meniscal repair with trephination and platelet rich plasma

Biological: trephination with platelet rich plasma

Interventions

trephination with placebo BIOLOGICAL

trephination under US guidance and placebo injection

trephination with placebo

trephination with platelet rich plasma BIOLOGICAL

trephination under US guidance and platelet rich plasma injection

trephination with platelet rich plasma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

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

Otwock, Masovian Voivodeship, 05-400, Poland

Location

MeSH Terms

Interventions

Trephining

Intervention Hierarchy (Ancestors)

Craniotomy; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Rafal Kaminski

  PCME, Otwock, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chair of Division

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: February 28, 2017
• Study Start: January 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Locations

PL (1)