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New knee implant helps patients forget they have a fake joint

NCT ID NCT02501733

Disease control Sponsor: Medacta USA Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a specific knee replacement, the Medacta GMK Sphere, works over time. Researchers measured how often patients forgot about their artificial knee in daily life, two and five years after surgery. The study involved 260 adults with osteoarthritis who needed a total knee replacement. The goal was to see if this implant helps people move and feel better long-term.

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

260 people

The number who actually took part.

Started

Jun 2015

Finished

Dec 2024

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

21 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patients willing to sign the informed consent * Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self evaluations. * Male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery. * Patients requiring a primary total knee replacement. * Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). * Patients with intact collateral ligaments. Exclusion Criteria: * Patients with inflammatory arthritis. * Patients that are morbidly obese, body mass index (BMI) \> 40. * Patients with a history of total or unicompartmental reconstruction of the affected joint. * Patients that have had a high tibial osteotomy or femoral osteotomy. * Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * Patients with a systemic or metabolic disorder leading to progressive bone deterioration. * Patients that are immunologically compromised, or receiving chronic steroids (\> 30 days). * Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis. * Patients with knee fusion to the affected joint. * Patients with an active or suspected latent infection in or about the knee joint. * Patients that are prisoners.

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Conditions

The condition(s) this trial relates to.

avascular necrosis osteoarthritis

As listed by the trial registrant

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

Osteoarthritis

Contacts and locations

Locations

  • McBride Orthopedic Hospital

    Oklahoma City, Oklahoma, 73103, United States

  • Norhtwestern University

    Chicago, Illinois, 60611, United States

  • Spokane Joint Replacement Center

    Spokane, Washington, 99218, United States

  • Texas Orthopedics

    Austin, Texas, 78759, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

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