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NCT Number: NCT06705985

Early Artificial Lateral Prosthesis

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, Netherlands

Location contact

Katja Saris, PhD

CONTACT

[email protected]

003124361492

S van de Groes, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Has an active infection or tumor (local or systemic)
  • Has any type of knee joint inflammatory disease including Sjogren's syndrome
  • Has neuropathic knee osteoarthropathy, also known as Charcot joint
  • Has any medical condition that does not allow possible arthroscopy of the knee
  • Has neurological deficit (sensory, motor, or reflex)
  • Anticipates having another lower extremity surgery during the study period
  • Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
  • Has received any corticosteroid knee injections ≤ 3 months prior to surgery
  • Has proven osteoporosis
  • Is on immunostimulating or immunosuppressing agents
  • 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)
  • Is a female who is lactating, expecting, or is intending to become pregnant during the study period
  • Is an active smoker at the time of surgery
  • Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
  • 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

Treatment and study plan

Implantation of lateral meniscus prosthesis

Device

Implantation of a lateral meniscus prosthesis after meniscectomy.

Primary outcomes

  1. Adverse events

    Time frame: 12 months after implantation.

    Adverse events within 12 months after implantation.

  2. Implant integrity

    Time frame: 12 months after implantation.

    Assessed by MRI.

Secondary outcomes

  1. KOOS

    Time frame: 24 months.

    KOOS (overall including all subscales) at 6 weeks, 3, 6, 12, 24 months.

  2. Lysholm

    Time frame: 24 months.

    Lysholm scale at 6 weeks, 3, 6, 12, 24 months.

  3. OKS

    Time frame: 24 months.

    OKS at 6, 12, 24 months.

  4. EQ-5D-5L

    Time frame: 24 months.

    EQ-5D-5L at 6, 12, 24 months.

  5. WORQ

    Time frame: 24 months.

    WORQ at 6 weeks, 3, 6, 12, 24 months.

  6. SF-36

    Time frame: 24 months.

    SF-36 at 6, 12, 24 months.

  7. Likert - Patient satisfaction

    Time frame: 24 months.

    Patient satisfaction on a 5-point Likert scale at 6, 12, 24 months.

  8. Tegner Activity Scale

    Time frame: 24 months.

    Tegner Activity Scale at 6 weeks, 3, 6, 12, 24 months.

  9. IKDC Knee Examination Form

    Time frame: 24 months.

    IKDC Knee Examination Form at screening, surgery, 6 weeks, 3, 6, 12, 24 months.

  10. Knee X-ray (weight-bearing)

    Time frame: 24 months.

    Knee X-ray (weight-bearing) at 6, 12, and 24 months to evaluate the height of the joint space.

  11. Knee X-ray (weight-bearing, long-leg)

    Time frame: 24 months.

    • Knee X-ray (weight-bearing, long-leg) at 6, 12, and 24 months to evaluate the mechanical axis.
  12. Knee X-ray (non-weight-bearing, supine)

    Time frame: 24 months.

    Knee X-ray (non-weight-bearing, supine) at 12, and 24 months to evaluate the mechanical axis.

  13. Knee MRI (non-weight-bearing)

    Time frame: 24 months.

    Knee MRI (non-weight-bearing) at implantation surgery (+(within

    1 week, preferably peroperative), 6, 12, and 24 months for implant and joint integrity (cartilage status) assessment (including focal defects, bone marrow lesions, and bone tunnels/fixation sites).

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

ATRO Medical B.V.

Industry

Registry information

Official study title

Treatment of Lateral Knee Joint Pain with Artificial Lateral Meniscus Prosthesis After Meniscectomy

Acronym: EARTH

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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