Early Artificial Lateral Prosthesis

NCT ID: NCT06705985

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-21
• Study Completion Date: 2028-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lateral Meniscus Prosthesis

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.

Group Type: EXPERIMENTAL

Implantation of lateral meniscus prosthesis

Intervention Type: DEVICE

Implantation of a lateral meniscus prosthesis after meniscectomy.

Interventions

Implantation of lateral meniscus prosthesis

Implantation of a lateral meniscus prosthesis after meniscectomy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Is aged 18 to 70 years (inclusive) at the time of screening

2. Has a history of partial or total meniscectomy

3. 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

4. Has a KOOS Pain of ≤ 75 at the time of screening

5. 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)

6. Has neutral alignment < ± 3° of the mechanical axis

7. Is willing to be implanted with the LMP System and to comply with instruction for use

8. Is able and willing to do the study required follow-up visits, questionnaires, X-rays, and MRI

9. Is able and willing to understand and sign the study Informed Consent Form

10. Is able to read and understand the national language of the country in which the clinical site is located

Exclusion Criteria

1. Has progressed knee osteoarthritis, Kellgren & Lawrence grade 3- 4 in the lateral compartment

2. 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

3. Has medial compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the medial compartment

4. Has a varus or valgus knee deformity of > 3°

5. Has a valgus alignment that is not passively correctable

6. 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)

7. Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment

8. Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartment

9. Had an ACL reconstruction performed < 9 months prior to surgery

10. Has a BMI > 35 at the time of screening

11. Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the lateral meniscus prosthesis

12. Has a knee flexion contracture > 10°

13. Has flexion < 90°

14. Had a knee alignment correction osteotomy < 9 months ago

15. Has insufficiency fractures or avascular necrosis of the lateral compartment

16. Has an active infection or tumor (local or systemic)

17. Has any type of knee joint inflammatory disease including Sjogren's syndrome

18. Has neuropathic knee osteoarthropathy, also known as Charcot joint

19. Has any medical condition that does not allow possible arthroscopy of the knee

20. Has neurological deficit (sensory, motor, or reflex)

21. Anticipates having another lower extremity surgery during the study period

22. Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)

23. Has received any corticosteroid knee injections ≤ 3 months prior to surgery

24. Has proven osteoporosis

25. Is on immunostimulating or immunosuppressing agents

26. Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or study outcomes (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp)

27. Is a female who is lactating, expecting, or is intending to become pregnant during the study period

28. Is an active smoker at the time of surgery

29. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)

30. Has a condition or be in a situation that, in the Investigator's opinion, may confound the clinical investigation results, may risk the safety of the patient, or may interfere significantly with the subject's participation in the clinical investigation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ATRO Medical B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Central Contacts

CDD

Role: CONTACT

info@atromedical.com

0031616672227

Facility Contacts

Katja Saris, PhD

Role: primary

Katja.Saris-deLeuw@Radboudumc.nl

003124361492

S van de Groes, MD, PhD

Role: backup

Other Identifiers

AM-101

Identifier Type: -

Identifier Source: org_study_id