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Which knee implant stays put longer? a Head-to-Head test

NCT ID NCT05651009

Disease control Sponsor: Helse Møre og Romsdal HF 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial aims to see if there is a difference in how well two cementless total knee replacement implants hold up over time. About 50 people with knee osteoarthritis will be randomly assigned to receive either the Triathlon Tritanium or the GMK Sphere implant. Using CT scans, researchers will measure tiny movements of the implant, which may indicate how long it will last. The goal is to find out which design offers better long-term stability.

What this could mean

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

Active substance
Total knee arthroplasty (TKA) with two different cementless implant designs: Triathlon Tritanium (Stryker) and GMK Sphere (Medacta)
What this could lead to
If one implant proves more stable, it could point toward a longer-lasting knee replacement option, potentially reducing the need for revision surgery.
What could go wrong
This is a small, early-stage trial, so results may not apply to all patients. Implant stability does not guarantee long-term success, and surgery carries standard risks like infection or implant loosening.

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

50 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

50 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: • Patients referred to Kristiansund Hospital for primary total knee replacement surgery for osteoarthritis with Kellgren \& Lawrence grade 3 or 4 Exclusion Criteria: * Preoperative severe deformity (Hip-Knee-Ankle angle of \>5 (valgus) or \<-15 degrees (varus) on a full-length leg image at weight bearing * Preoperative flexion contracture more than 15° * Less than 50 and more than 75 years of age at the time of surgery * Use of walking aids because of other musculoskeletal and neuromuscular problems * Preoperative diagnosis other than osteoarthritis or avascular necrosis (e.g. rheumatoid arthritis, tumours) * Revision arthroplasty * Obesity with BMI\>35 g/m2 * Lateral collateral ligament deficient knee * Previous knee joint infection * Cognitive dysfunction or severe psychiatric disorders.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

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

Knee osteoarthritis

Contacts and locations

Locations

  • Kristiansund Hospital, Møre and Romsdal Hospital Trust

    Kristiansund, Møre and Romsdal, 6508, Norway

More trials for these conditions

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