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

Meniscus Lesion Clinical Trial

— Prolotherapy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066583
• Other study ID #: 501-1-07-18-15
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2016
• Est. completion date: June 2020

Study information

• Verified date: June 2020
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Meniscus Lesion

Intervention

Biological:
• trephination with placebo
trephination under US guidance and placebo injection
• trephination with platelet rich plasma
trephination under US guidance and platelet rich plasma injection

Locations

Country	Name	City	State
Poland	Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital	Otwock	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

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