Degenerative Meniscus Without Osteoarthritis : Arthroscopic Partial Menisectomy Versus Platelet Rich Plasma (APM-PRP) — APM-PRP  

Platelet-Rich Plasma Clinical Trial

Official title: Arthroscopic Partial Menisectomy or Platelet Rich Plasma in Degenerative Meniscus Without Osteoarthritis? Study Protocol for a Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

This study compares arthroscopic partial menisectomy (APM) and platelet rich plasma (PRP) for degenerative meniscal injury of the knee.

The current state of knowledge is poor. There are few comparative studies that have been performed and only on surgical treatment or rehabilitation. Moreover, these studies show contradictory results.

The main objective of this study is to compare APM and PRPinfiltration, in terms of pain reduction, which is greater with the surgical technique than in the PRP infiltration group.

The hypothesis of this study is that there is superiority of surgery over PRP infiltration.

The main evaluation criterion is the pre-post-operative pain by a simplified numerical scale.

Clinical Trial Description

Degenerative meniscal tear is a chronic, slowly evolving condition that typically involves horizontal cleavage of the meniscus and affects middle-aged men and women. The prevalence is high, with a medial meniscal tear found on imaging in 13-28% of persons older than 50 years of age. In the absence of evidence of knee osteoarthritis, only 22% of patients with meniscal tears have knee symptoms. Symptomatology is internal knee pain, often related to activities or positions such as squatting or kneeling, and usually improves with rest. The optimal treatment for nontraumatic degenerative meniscal tears is currently controversial.

Arthroscopic partial meniscectomy (APM) is one of the most commonly performed orthopedic surgical procedures for patients with meniscal degeneration to improve knee function and reduce pain. However, there is no reliable evidence that arthroscopic partial meniscectomy improves outcomes in the middle-aged population with degenerative meniscal disease. A study comparing APM with sham surgery found no significant difference for APM at six months and at one year with a slightly better outcome for APM at two months. A meta-analysis showed that APM combined with medical exercise leads to a better outcome than isolated medical exercise in immediate follow-up at two months, but there is no difference at 6 months.

Thorlund et al. reported that the effect of knee arthroscopy for degenerative knee (meniscal tears with or without osteoarthritis) was limited at 3-6 months after the procedure with 0.17 to 0.96% venous embolism.

A recent study reported a 15.7% conversion rate from APM to Total Knee Arthroplasty (TKA) at 10 years postoperatively.

There are numerous types of infiltrations with the goal of a pain-free knee. Hyaluronic acid (HA), might have a healing-promoting effect and tend to delay the need for APM, but this effect is still controversial and has not been verified in studies. There is increasing clinical interest in testing new biological products to improve the efficacy of intra-articular injection treatment.

Platelet-rich plasma (PRP) is an autologous whole blood extract containing high concentrations of platelets and growth factors that promises to promote and accelerate recovery of injured ligaments, muscles, tendons, and joints by injecting the patient's own platelets. It has few side effects and can be performed in a consultation setting. It is still controversial and results are inconsistent, which could be due to the use of leukocyte-poor PRP or leukocyte-rich PRP, which have different functions such as anti-infectious actions and immune regulation. Moreover, there is confusion between PRP and platelet-rich fibrin (PRF).

Regarding knee osteoarthritis and the comparison with HA, 11 meta-analyzes came to positive conclusions and 2 contradicted the efficacy.

Regarding injection of PRP into a degenerative meniscal lesion, functional outcomes appear to improve and failure rates decrease. In a case-control study of open meniscal repair of horizontal tears in young patients, the addition of PRP slightly improved clinical outcomes at mid-term follow-up.

Nonoperative treatment has a conversion rate to surgery in 0 to 35% of patients. Meanwhile, osteoarthritis after meniscectomy is common. In a multicenter study from French Arthroscopy Society, the prevalence of joint line narrowing in the medial meniscus was 22% with a mean follow-up of 13 years.

There are several treatment options for symptomatic degenerative meniscal tears. However, to the investigators' knowledge, there is no report on PRP and no results comparing APM and PRP have been reported.

Therefore, the aim of this study is to compare two treatments; APM and PRP, both followed by rehabilitation, in terms of knee pain, knee function and satisfaction in patients with degenerative meniscal tears without osteoarthritis. The hypothesis is that APM would be superior than PRP in terms of pain and functional outcomes at 3 months postoperative ;

Related Conditions & MeSH terms

• Meniscectomy
• Meniscus; Degeneration
• Osteoarthritis
• Platelet-Rich Plasma

• NCT number: NCT04972331
• Study type: Interventional
• Source: Institut de Chirurgie Reparatrice Locomoteur et Sports
• Contact: Jules DESCAMPS, MD
• Phone: 0698270789
• Email: dr.jdescamps@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Completion date: June 1, 2023