Randomised Total Knee Arthroplasty With Attune S+ or NexGen CR

NCT05464641 | Completed

• 1 other identifier: Attune S+ or NexGen CR
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Knee arthroplasty

Outcome Measures

Primary Outcomes (2)

• Oxford knee score

  Oxford knee score, a 12-item patient-reported PRO

  preoperative

• Oxford knee score

  Oxford knee score, a 12-item patient-reported PRO

  2 year postoperative

Study Arms (2)

preoperative

ACTIVE COMPARATOR

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

Other: Oxford knee score

postoperative

ACTIVE COMPARATOR

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

Other: Oxford knee score

Interventions

Oxford knee score OTHER

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

postoperative; preoperative

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medial or lateral primary OA Ahlbäck Grade 2-4
• Varus or valgus deformity ≤10 degrees, extension defect ≤10 degrees
• Age 40-75 years
• BMI \<35
• ASA 1-3.
• Coming from independent living in own home
• Written informed consent.

You may not qualify if:

• Cortisone treatment during the last 6 months before operation
• Neurological diseases with symptoms, stroke with sequel
• Endocrine diseases with symptoms
• OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities
• BMI \>=35

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Roland Zügner

Gothenburg, SE 41310, Sweden

Location

Study Officials

• Roland Zügner, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: preoperative and 2 year postoperative
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: preoperative and 2 year postoperative

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: July 19, 2022
• Study Start: January 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)