Last updated: March 16, 2022
Sponsor: ATRO Medical B.V.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Knee Injuries
Treatment
N/AClinical Study ID
NCT05297175
AM-002
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Has medial compartment knee pain and had a medial partial or total meniscectomy > 6months ago. The lack of meniscus tissue is confirmed by patient history and MRI
- Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
- Is between age 18 and 70 years (inclusive) at the time of screening
- Has neutral alignment ± 5° of the mechanical axis, i.e., the angle formed by a linedrawn from the center of the femoral head to the medial tibial spine and a line drawnfrom the medial tibial spine to the center of the ankle joint, as confirmed by X-ray
- Is willing to be implanted with the Trammpolin® medial meniscus prosthesis
- Is willing and able to comply to the clinical investigation required follow up visits,questionnaires, X-rays and MRI's
- Is able and willing to understand and sign the clinical investigation Informed ConsentForm
- Is able to read and understand the national language of the country in which therelevant clinical site is located
Exclusion
Exclusion Criteria:
- Has a symptomatic knee because of a tear that could potentially be addressed by arepeat partial meniscectomy
- Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial tibialplateau or femoral condyle that potentially could contact a Trammpolin® medialmeniscus prosthesis
- Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilagescore in the lateral compartment
- Has a varus or valgus knee deformity of > 5° requiring a tibial or femoral osteotomy
- Has a varus alignment that is not passively correctable
- Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury ofthe anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/orlateral collateral ligament (LCL) and/or medial collateral ligament (MCL)
- Has significant trochlear dysplasia, patellar instability or symptomatic patellarmisalignment
- Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilagescore in the patellar compartment.
- Compared to a normal knee, has obvious radiological evidence of medial femoralsquaring, anatomical variance in the medial tibial plateau, or irregularly shapedcartilage surface
- Had an ACL reconstruction performed < 9 months prior to surgery
- Has a BMI > 30 at the time of screening
- Has a knee flexion contracture > 10°
- Has a knee flexion < 90°
- Had a previous High Tibial Osteotomy (HTO) < 1 year ago
- Has insufficiency fractures or avascular necrosis of the medial 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)
- Is currently involved in another investigation of the lower extremity
- Anticipates having another lower extremity surgery during the clinical investigationperiod
- 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 affectambulation or KOOS (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing anoticeable limp)
- Is a female who is lactating, expecting, or is intending to become pregnant during theclinical investigation period
- Is mentally incapacitated (incapable of appraising or controlling conduct) or havemental disability (e.g., dementia or Alzheimer's)
- Has a condition or be in a situation that, in the Investigator's opinion, may confoundthe clinical investigation results, may risk the safety of the patient, or mayinterfere significantly with the subject's participation in the clinical investigation
Study Design
Total Participants: 10
Study Start date:
October 19, 2021
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Haaglanden Medisch Centrum
Den Haag, 2597 AX
NetherlandsActive - Recruiting
MUMC+
Maastricht, 6229 HX
NetherlandsActive - Recruiting
Sint Maartenskliniek
Nijmegen, 6574 NA
NetherlandsActive - Recruiting
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