CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Medacta International, GMK Sphere medially stabilized kneeprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02861794
NCT02861794N/ACompleted

Evaluation of Early Migration of Medially Stabilized Arthroplasty as a Predictor of Long Time Survivorship (Implant Design Study)

Oslo University Hospital·interventional·Posted Aug 10, 2016·Updated Nov 25, 2025

In Brief

A clinical study evaluating Medacta International, GMK Sphere medially stabilized knee for Knee Osteoarthritis. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patient satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have been developed to solve the problem. However, most of their designs are based on experimental data and little has been studied about their actual performance in vivo. In this study, the investigators will analyze the in vivo stability of the Global Medacta Knee Sphere (GMK Sphere) implant. Migration of the implants will be monitored with a high precision measuring method called Radiostereometric Analysis (RSA). The investigators assume the investigators study will contribute the development of more satisfying knee implants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNorway

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 10, 2016
Enrollment StartMay 1, 2016
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 9.9 years ago

Interventions

Medacta International, GMK Sphere medially stabilized kneeprocedure

Total Knee Replacement