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Randomised Total Knee Arthroplasty With Attune S+ or NexGen CR

NCT05464641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-25

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the clinical performance of the Attune S+ knee primarily based on evaluation with use of Oxford Knee Score. The NexGen TKR will be used as reference standard. The second aim is to study component migration with model-based RSA in a subgroup of patients with model-based RSA and to compare these measurements with migration measurements with use of CT-based migration measurements. The investigators hypothesis is that the results two years after insertion of these two TKR designs will be about equal.

Conditions

  • Arthroplasty, Replacement, Knee

Interventions

OTHER

Oxford knee score

The Oxford Knee Score (OKS) is a 12-item patient-reported PRO, low score worse

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Roland Zügner, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Sweden

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 NCT05464641 on ClinicalTrials.gov