The VENUS (Verifying the Effectiveness of the NUsurface® System) Clinical Study

Completed

• Conditions: medial meniscus deficiency; medial meniscus torn; 10023213

• Registration Number: NL-OMON46974
• Lead Sponsor: Active Implants LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-11-01
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

Inclusion Criteria: In the opinion of the investigator, if ALL of the following 8 conditions are applicable for the index knee, then the patient is included if he/she: ;1. Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
2. Has a KOOS Pain of * 75 (100 being the highest attainable and no pain)
3. Is between age 30 and 75 years (inclusive) at the time of study treatment
4. Has neutral alignment ± 5º of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine
to the center of the ankle joint
5. Has * 2 mm intact medial meniscal rim capable of being fitted with a NUsurface® device AND is also recommended for the baseline non-surgical (and, if likely to receive benefit, any injection)
therapies to be administered in the study.
6. Is willing to be entered into either arm of the study: implanted with the NUsurface device OR
treated with the recommended control arm therapies.
7. Is able to do the study required follow up visits, questionnaires, X-rays, and MRI*s
8. Is able and willing to understand and sign the study Informed Consent Form
9. Is able to read and understand the national language of the country in which the relevant clinical site is located

Exclusion Criteria

Exclusion Criteria: If ANY of the following 35 conditions are applicable, then the patient is excluded if he/she:;1) Has a symptomatic knee because of a tear that could be addressed by a repeat partial
meniscectomy leaving > 4 mm of medial meniscus rim
2) Has evidence of a Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral
condyle that potentially could contact a NUsurface implant (e.g., a focal lesion > 0.5 cm correlating to a circular defect of > 8 mm in diameter)
3) Has complete disruption of the posterior root attachment of the meniscus
4) Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in the lateral
compartment
5) Has a varus or valgus knee deformity > 5º requiring a tibial or femoral osteotomy
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 Outerbridge cartilage score in the
patellar compartment.
9) Compared to a normal knee, has obvious radiological evidence of medial femoral squaring,
anatomical variance in the medial tibial plateau, or irregularly shaped cartilage surface
10) Had an ACL reconstruction performed < 9 months prior to study treatment
11) Has a BMI > 32.5 at the time of study treatment
12) Decides to receive (if eligible and an option) allograft medial meniscus transplantation
13) Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or
ceramic, not including the NUsurface® Meniscus Implant
14) Has a knee flexion contracture > 10º
15) Has flexion < 90º
16) Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial
Osteotomy (HTO)
17) Has insufficiency fractures or avascular necrosis of the medial compartment
18) Has an active infection or tumor (local or systemic)
19) Has any type of knee joint inflammatory disease including Sjogren*s syndrome
20) Has neuropathic knee osteoarthropathy, also known as Charcot joint
21) Has any medical condition that does not allow possible arthroscopy of the knee
22) Has neurological deficit (sensory, motor, or reflex)
23) Is currently involved in another investigation of the lower extremity
24) Anticipates having another lower extremity surgery during the study period
25) Is contraindicated for hyaluronic acid injections (i.e., patients with known hypersensitivity [allergy] to hyaluronan [sodium hyaluoronate] preparations); patients having knee joint infections or skin diseases or infections in the site of possible injections
26) Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
27) Has received any corticosteroid knee injections * 3 months prior to study treatment
28) Has chondrocalcinosis
29) Is on immunostimulating or immunosuppressing agents
30) Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS
(e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp)
31) Is a female who is

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint components of the study are as follows:<br /><br><br /><br>Effectiveness:<br /><br><br /><br>The KOOS Pain Subscale and KOOS Overall Scale (Average of the 5 KOOS Subscales)<br /><br>relative to baseline * at 24 months<br /><br><br /><br>Investigational Group Device-Related Secondary Surgical Interventions: The<br /><br>device related secondary surgical interventions of the NUsurface®<br /><br>Meniscus Implant during the 24 month post-operative period.<br /><br><br /><br>Control Group Post-InterventionTreatment Surgical Procedures: The treatment<br /><br>failures of the control group are defined as any surgery on<br /><br>the index knee medial compartment up to and including 24 months.<br /><br><br /><br>Each of these components of Overall Success will be analysed separately, but<br /><br>their analyses will not affect the 0.05 type I error rate (threshold p-value of<br /><br>0.05 for significance) for the test of the primary superiority hypothesis. </p><br>