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

Centre of Postgraduate Medical Education

Status and phase: Completed; Phase 3; Phase 2

Conditions: Meniscus Lesion

Treatments: Biological: trephination with placebo; Biological: trephination with platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03066583

501-1-07-18-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

trephination with placebo

Placebo Comparator group

Description:

meniscal repair with trephination and placebo

Treatment:

Biological: trephination with placebo

trephination with platelet rich plasma

Experimental group

Description:

meniscal repair with trephination and platelet rich plasma

Treatment:

Biological: trephination with platelet rich plasma