Meniscus related unicompartimental knee pain. Meniscus related knee pain
Conditions
Interventions
Artimis® Meniscus Prosthesis System (Artimis® System)
Sponsors
ATRO Medical B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Is aged 18 to 70 years (inclusive) at the time of screeningHas a KOOS Pain of = 75 at the time of screeningHas a joint condition defined by Modified Outerbridge and Kellgren & Lawrence up to grade 3 (inclusive) in the index compartment> Failed meniscus surgery, e.g. (partial) meniscectomy, OR > Has an irreparable meniscus root lesionHas neutral alignment of the mechanical axis. For medial meniscus prosthesis varus less than 5°, for lateral meniscus prosthesis valgus less than 5° Failed conservative treatment options (non-operative treatments of the knee, i.e., self-management exercise programs, physical therapy, braces, pain medication, or intra-articular corticosteroids)Is willing to be implanted with the Artimis® System and to comply with instruction for useIs able and willing to do the study required follow-up visits, questionnaires, X-rays, and MRIIs able and willing to understand and sign the study Informed Consent FormIs able to read and understand the national language of the country in which the clinical site is located
Exclusion criteria
Exclusion criteria: Has evidence of a modified Outerbridge Grade IV cartilage loss on the tibial plateau or femoral condyle that potentially could contact the meniscus prosthesis > 2cm2Has unicompartment pain and Grade IV modified Outerbridge cartilage score in the contralateral compartment > 2cm2Has severe knee osteoarthritis, Kellgren & Lawrence grade 4 in the index compartmentHas a varus > 5°in case of medial meniscus prosthesis or valgus > 5° with a lateral meniscus prosthesisHas a valgus alignment that is not passively correctableHas 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 patellar instability or symptomatic patellar misalignmentHas patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartmentHad an ACL reconstruction performed < 9 months prior to surgeryHas a BMI > 35 at the time of screeningReceived any type of prosthetic knee implant in the target joint made of artificial non-resorbable plastic, metal or ceramic, not including PCU meniscus prosthesisHas a knee flexion contracture > 10°Has flexion < 90°Had a knee alignment correction osteotomy < 9 months agoHas insufficiency fractures or avascular necrosis of the lateral compartmentHas an active infection or tumor (local or systemic)Has any medical condition that does not allow arthroscopy of the knee and/or placement of the implant.Has neurological deficit (sensory, motor, or reflex)Anticipates having another lower extremity surgery during the study periodHas received any corticosteroid knee injections = 3 months prior to surgeryHas proven osteoporosisIs on immunostimulating or immunosuppressing agentsHas 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessed by device related (S)AEs within 6 months of surgery.Artimis® implant integrity assessed by knee MRI (non-weight-bearing extrusion measurement) at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Follow-up (post-operative) compared to baseline (pre-operative):At 3-, 6-, 12-, 24-month follow-up:KOOS (overall including all subscales)WOMAC (KOOS derived)Pain VASLysholm scaleOKSAt 6-, 12-, 24-month follow-up:EQ-5D-5LWORQAt 3-, 6-, 24-month follow-up:Physical examination by IKDC Knee Examination Form.At = 1-week, 6-, 24-month follow-up: Knee MRI (non-weight-bearing) for implant and joint integrity (cartilage status) assessment (including focal defects, bone marrow lesions, and bone tunnel(s)/fixation site(s)).At 24-month follow-up:Knee X-ray (weight-bearing) to evaluate the height of the joint space.Knee X-ray (weight-bearing, long-leg) to evaluate the mechanical axis.Knee X-ray (non-weight-bearing, supine) to evaluate the mechanical axis.At surgery and resurgery:Sampling of synovial fluid from the index joint to evaluate foreign body reaction.Sampling of synovial fluid and synovial tissue from the index joint to evaluate foreign body reaction in case of unanticipated arthroscopic evaluation of device performance or device explantation (if applicable) compared to implantation surgery. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactT. Struik
ATRO Medical B.V.
Outcome results
None listed