Early Artificial Lateral Prosthesis

NCT06705985 | Not Yet Recruiting DMC

• 1 other identifier: AM-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The device subject to this clinical investigation has been developed for treating patients with a history of partial or total meniscectomy, who suffer from symptomatic unicompartmental pain in the meniscus-deficient knee: the post-meniscectomy pain syndrome. The intended purpose of the system is to replace the lateral native meniscus and its function after meniscectomy by distributing tibio-femoral loads and provide a clinically relevant reduction of pain and improvement of joint function.

Conditions

Post-Meniscectomy Pain Syndrome

Keywords

meniscus; lateral; prosthesis

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Adverse events within 12 months after implantation.

  12 months after implantation.

• Implant integrity

  Assessed by MRI.

  12 months after implantation.

Secondary Outcomes (13)

• KOOS

  24 months.

• Lysholm

  24 months.

• OKS

  24 months.

• EQ-5D-5L

  24 months.

• WORQ

  24 months.

Study Arms (1)

Lateral Meniscus Prosthesis

EXPERIMENTAL

Implantation of the Lateral Meniscus Prosthesis, intended to replace the function of the natural meniscus to provide unicompartmental pain relief in the meniscus-deficient knee.

Device: Implantation of lateral meniscus prosthesis

Interventions

Implantation of lateral meniscus prosthesis DEVICE

Implantation of a lateral meniscus prosthesis after meniscectomy.

Lateral Meniscus Prosthesis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is aged 18 to 70 years (inclusive) at the time of screening
• Has a history of partial or total meniscectomy
• Has post-meniscectomy pain syndrome (defined as symptomatic unicompartmental pain in the meniscus- deficient knee without severe cartilage damage- Kellgren \& Lawrence grade 3-4) in the lateral compartment as confirmed by patient history and MRI
• Has a KOOS Pain of ≤ 75 at the time of screening
• Failed conservative treatment options (non-operative treatments of the knee, i.e., self-management exercise programs, physical therapy, braces, pain medication, and intra-articular corticosteroids)
• Has neutral alignment \< ± 3° of the mechanical axis
• Is willing to be implanted with the LMP System and to comply with instruction for use
• Is able and willing to do the study required follow-up visits, questionnaires, X-rays, and MRI
• Is able and willing to understand and sign the study Informed Consent Form
• Is able to read and understand the national language of the country in which the clinical site is located

You may not qualify if:

• Has progressed knee osteoarthritis, Kellgren \& Lawrence grade 3- 4 in the lateral compartment
• Has evidence of a modified Outerbridge Grade IV cartilage loss on the lateral tibial plateau or femoral condyle that potentially could contact the meniscus prosthesis
• Has medial compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the medial compartment
• Has a varus or valgus knee deformity of \> 3°
• Has a valgus alignment that is not passively correctable
• Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL)
• Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment
• Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartment
• Had an ACL reconstruction performed \< 9 months prior to surgery
• Has a BMI \> 35 at the time of screening
• Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the lateral meniscus prosthesis
• Has a knee flexion contracture \> 10°
• Has flexion \< 90°
• Had a knee alignment correction osteotomy \< 9 months ago
• Has insufficiency fractures or avascular necrosis of the lateral compartment

Sponsors & Collaborators

• ATRO Medical B.V.: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

Location

Central Study Contacts

CDD

CONTACT

0031616672227; info@atromedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The objective of the clinical investigation is to evaluate the safety and performance of the LMP system and to demonstrate that the system is able to replace the function of the natural meniscus to provide pain relief in the lateral compartment of the meniscus-deficient knee. No formal hypothesis testing will be conducted, given the feasibility design of this clinical investigation. Evaluation of safety of the LMP system will occur throughout the investigation with the reporting of the nature and frequency of all adverse events observed during the clinical investigation and their timing, severity and relatedness to the investigational device or procedure. In addition, the incidence and nature of secondary surgical intervention will be assessed.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 26, 2024
• Study Start: November 21, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

NL (1)