Knee implant movement measured to boost future joint replacements
NCT ID NCT02861794
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how much a new knee implant (GMK Sphere) moves inside the body over five years in 44 people with knee osteoarthritis. Researchers used a special X-ray technique to measure implant stability. The goal was to gather data to help design better knee replacements that feel more natural and last longer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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44 people
The number who actually took part.
- Started
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May 2016
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with knee osteoarthritis Exclusion Criteria: * Preoperative severe deformity (Femoro-tibial angle \< 175°or \> 190°measured on a full-length leg image at weight bearing) * Preoperative flexion contracture more than 15° * Preoperative limited range of motion under anesthetics (less than 110°) * Less than 50 or 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 and avascular necrosis (e.g. rheumatoid arthritis, tumors) * Revision arthroplasty * Obesity with BMI \>35 * Impaired collateral ligaments * Malposition of femoral and tibial implants (Internally rotated or more than 10° externally rotated implants will be excluded. The rotation of femoral implant is measured on postoperative CT images in reference to surgical epicondylar line. The rotation of tibial implant is determined according to Berger's measurement) * Postoperative revision surgery due to deep wound infection
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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
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Oslo University Hospital
Oslo, Oslo, 0470, Norway
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Other studies related to the condition(s) this trial covers.
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