Stability of Contemporary Knee Arthroplasty

NCT02861794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Medacta International, GMK Sphere medially stabilized knee

Total Knee Replacement

Sponsors & Collaborators

  • Helse More and Romsdal Trust

    collaborator UNKNOWN
  • Medacta International SA

    collaborator INDUSTRY
  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Stephan Maximillian Røhrl, MD, PhD · Center for Implant and Radiostereometric Research Oslo (CIRRO)

  • Frank-David Oehrn, MD · Kristiansund Hospital, Helse More and Romsdal Trust

  • Lars Harald William Engseth, MD, PhD · Center for Implant and Radiostereometric Research Oslo (CIRRO)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Norway

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02861794 on ClinicalTrials.gov