Verifying the Effectiveness of the NUsurface® System (VENUS)

July 27, 2026 updated by: Active Implants

The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-centered, Prospective, Randomized, Interventional, Superiority Clinical Study

The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The NUsurface® Meniscus Implant is intended for use in patients with medial compartment pain that have had a previous partial medial meniscectomy.

Patients who meet the inclusion/exclusion criteria will be assigned by balanced randomization into one of two groups: the Meniscus Implants versus non-surgical standard of care. The KOOS (Knee injury and Osteoarthritis Outcome Score) and IKDC (International Knee Documentation Committee) forms will be used to provide a comprehensive evaluation of the patients' pre-intervention and post-intervention condition including activity levels, pain, swelling, locking, stability, support, sports activity, and quality of life assessment.

Study Type

Interventional

Enrollment (Actual)

337

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46143
        • OrthoIndy
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Woman's Hospital
      • Roxbury Crossing, Massachusetts, United States, 02120
        • New England Baptist Hospital
    • New York
      • Albany, New York, United States, 12206
        • Capital Region Orthopaedics
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • OrthoSouth
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Advanced Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
  • Is between age 30 and 75 years (inclusive) at the time of study treatment
  • Has neutral alignment ±5º of the mechanical axis, as measured from 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 and the center of the ankle joint
  • 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.
  • Is willing to be entered into either arm of the study: implanted with the NUsurface device OR treated with the recommended control arm therapies.
  • Is willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule
  • Is able and willing to understand and sign the Informed Consent Form
  • Is able to read and understand the English language
  • Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)

Exclusion Criteria:

  • Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy leaving > 4 mm of medial meniscus rim
  • 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 cm2 correlating to a circular defect of > 8 mm in diameter)
  • Has complete disruption of the posterior root attachment of the meniscus
  • Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in the lateral compartment
  • Has a varus or valgus knee deformity > 5º requiring a tibial or femoral osteotomy
  • 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 Outerbridge cartilage score in the patellar compartment.
  • 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
  • Had an ACL reconstruction performed < 9 months prior to study treatment
  • Has a BMI > 32.5 at the time of study treatment
  • Decides to receive (if eligible and an option) allograft medial meniscus transplantation
  • Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the NUsurface® Meniscus Implant
  • Has a knee flexion contracture > 10º
  • Has flexion < 90º
  • Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
  • 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 study period
  • Is contraindicated for hyaluronic acid injections (i.e., patients with known hypersensitivity [allergy] to hyaluronan [sodium hyaluronate] preparations); patients having knee joint infections or skin diseases or infections in the site of possible injections
  • 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 study treatment
  • Has chondrocalcinosis
  • Is on immunostimulating or immunosuppressing agents
  • 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)
  • Is a female who is lactating, expecting, or is intending to become pregnant during the study period
  • Is an active smoker
  • Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
  • Is a prisoner
  • Is a patient who has economic incentive not to improve

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational
The patients randomized to the Investigational Group will receive the NUsurface® Meniscus Implant.
Device: NUsurface® Meniscus Implant
The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
Active Comparator: Control
The patients randomized to the Control Group of the study will receive Non-Surgical Care (the current standard of care for this patient population).
Drug: NSAID's and Non-surgical Treatment Options
Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
Drug: Intra-Articular Injections with Corticosteroids
Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Drug: Intra-Articular Injections with Hyaluronic Acid (HA)
Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Success Composite Endpoint
Time Frame: 2 years
Overall Success is a composite endpoint computed at 24-Months whereby a subject must satisfy the pre-defined KOOS goals (KOOS Success), must have completed 24 Months with no disqualifying surgical intervention, and must have completed 24 Months with no device fracture and no subluxation on MRI confirmation.
2 years
Automatic Study Failure
Time Frame: 2 Years
The automatic treatment failure of the Control Group during the first 24-month period is any surgical intervention of the index knee. The automatic treatment failure of the Investigational Group during the first 24-month period is device removal or MRI detection of a dislocation or device fracture.
2 Years
KOOS Success
Time Frame: 2 years
KOOS Success is an element that contributes to Overall Success by computing KOOS Pain Subscale at 24 months compared to baseline, and KOOS Overall score at 24 months compared to baseline. Scores for each of the five subscales are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. For a subject to have KOOS Success their KOOS measures must be: KOOSpain ≥ 86.1 at 24 Months AND KOOSoverall ≥ 86.2 at 24 Months. Alternatively, a subject can have KOOS Success if KOOSpain ∆ (improvement from Baseline) ≥ 20 points at 24 Months AND KOOSoverall ∆ ≥ 20 points at 24 Months AND KOOSpain ≥ 40 points at 24 Months.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS Subscale - Pain
Time Frame: 2 Years
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
2 Years
KOOS Subscale - Symptoms
Time Frame: 2 Years
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
2 Years
KOOS Subscale - ADL
Time Frame: 2 Years
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
2 Years
KOOS Subscale - Sports and Recreation
Time Frame: 2 Years
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
2 Years
KOOS Subscale - Quality of Life
Time Frame: 2 Years
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
2 Years
KOOS Overall Score
Time Frame: 2 Years
Average of all 5 KOOS Subscales
2 Years
VAS Pain Score
Time Frame: 2 Years
Visual Analog Scale (VAS) Pain Score is scored from the best lowest score of 0 to the worse pain score of 100.
2 Years
WOMET Normalized Score
Time Frame: 2 Years

Western Ontario Meniscal Evaluation Tool is a disease specific quality of life measurement tool for patients with meniscal lesions. Each question is scored from 0 (most favorable condition) to 100 (least favorable condition).

When combining all scores from the 16 possible questions, the best and least symptomatic score is 0, and the highest and most symptomatic score possible is 1600. The score may be reported as a total overall score, as a total score for each domain, or as a percentage of normal by subtracting the total score from 1600, dividing by 1600, and multiplying by 100. If the normalized score is used, then the least favorable condition is 0 and the most favorable condition is 100.
2 Years
IKDC Subjective Knee Score
Time Frame: 2 Years
The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form is a patient-reported measure of knee symptoms, function, and sports activity. The total score ranges from 0 to 100, where 0 represents the worst symptoms/function and 100 represents the best; higher scores indicate a better outcome. The score is calculated by summing responses to the 18 items, then transforming to a 0-100 scale using: [(raw score - lowest possible raw score) / range of raw score] × 100. No subscale scores are reported.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Active Implants

Investigators

  • Principal Investigator: Elliott B Hershman, MD, Lenox Hill Hospital NYC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

May 3, 2022

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimated)

April 9, 2014

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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