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Plastic meniscus implant put to the test against standard care for knee pain

NCT ID NCT02108496

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether a plastic meniscus implant can outperform non-surgical treatments for people with persistent knee pain after a partial meniscus removal. Participants who had the surgery more than six months ago and are between 30 and 75 years old are randomly assigned to receive either the implant or standard care. Success is measured at two years by pain scores, the need for further surgery, and implant integrity on MRI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a polycarbonate-urethane meniscus implant reinforced with polyethylene fibers
What this could lead to
If it works, this could offer a new treatment option for people with persistent knee pain after meniscus removal, potentially delaying or avoiding knee replacement.
What could go wrong
This is an early-stage device trial, so the implant may not provide better pain relief than standard care and carries risks like device fracture, dislocation, or the need for removal surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

337 people

The number who actually took part.

Started

Jul 2014

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Advanced Orthopaedics

    Richmond, Virginia, 23294, United States

  • Brigham and Woman's Hospital

    Boston, Massachusetts, 02115, United States

  • Capital Region Orthopaedics

    Albany, New York, 12206, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • New England Baptist Hospital

    Roxbury Crossing, Massachusetts, 02120, United States

  • Ohio State University Medical Center

    Columbus, Ohio, 43221, United States

  • OrthoIndy

    Indianapolis, Indiana, 46143, United States

  • OrthoSouth

    Memphis, Tennessee, 38120, United States

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Other studies related to the condition(s) this trial covers.