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Comparison of an Old Versus a New Total Knee Replacement

NCT03548792 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2025-09-18

No results posted yet for this study

Summary

A randomized controlled clinical and RSA study, comparing 2 knee implants:

1. NexGen CR cemented total knee arthroplasty
2. Persona CR cemented total knee arthroplasty

3 hospitals will participate in the study:

* Helse Bergen HF, Kysthospitalet i Hagavik (KIH)
* Helse Førde HF, Lærdal sykehus
* Helse Bergen HF, Haukeland universitetssykehus (HUS) 1-3 surgeons in each hospital will perform the operations. There will be 80 patients in the 2 groups; a total of 160 study patients will be included. 30 in each group will be included for RSA. Radiostereometric analysis (RSA) will be used to measure migration and subsidence of components in addition to regular radiographs.

3 different knee scoring systems will be used to evaluate satisfaction and function. An activity monitor will be used to assess real-life physical behavior and walking speed to assess objectively measured mobility.

Data from the Norwegian Arthroplasty Register will be used to investigate the risk of revision.

Conditions

  • Osteoarthritis Knee

Interventions

RADIATION

RSA radiostereometric analysis

Tantalum beads will be inserted in polyethylene Component and in bone to assess micromotion of Components in radiographs

BEHAVIORAL

Clinical comparison

ActivePAL, walking speed

Sponsors & Collaborators

  • Helse-Bergen HF

    lead OTHER

Principal Investigators

  • Ove Furnes, Professor · Helse Bergen, Norwegian Arthroplasty Register

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-18
Primary Completion
2029-07-05
Completion
2029-07-05

Countries

  • Norway

Study Locations

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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 NCT03548792 on ClinicalTrials.gov