Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties

NCT06483178 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-13

No results posted yet for this study

Summary

The number of patients requiring knee replacements is increasing every year due to the combination of an aging population, increased patient expectancy, and rising levels of obesity. Therefore, newer implants, or design features, are introduced on a regular basis to try to improve patient outcomes. In 2013, DePuy Synthes launched the Attune Knee System to provide improved range of motion and address the unstable feeling some patients experience whilst performing everyday activities, such as going down stairs. The Attune cementless rotating platform knee was first implanted in September 2016. In 2004, the first Triathlon total knee designed by Stryker was implanted. Registry figures for both the Attune and Triathlon knees are promising with good implant longevity and outcomes.

There is only a small amount of literature available on the Attune knee as it is still a relatively new implant. Worldwide, the Triathlon is widely used and is also a well-established, successful implant used in the investigators' unit. This study will help to determine whether the Attune can improve patient outcomes in terms of gait analysis assessed by walking on a treadmill, patient reported outcome measures and X-ray outcomes when compared to the Triathlon knee. 90 patients who will undergo knee replacement and meet the inclusion criteria and agree to take part will be randomly placed in one of two groups to receive either the Attune or Triathlon knee implant.

Conditions

Interventions

DEVICE

Attune knee implant

Attune cementless cruciate retaining rotating platform implant (DePuy Synthes) with a standard gap balancing cruciate sacrificing surgical technique

DEVICE

Triathlon knee implant

Triathlon cementless condylar stabilised implant (Stryker) with a standard gap balancing cruciate sacrificing surgical technique

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER
  • Trauma and Orthopaedics Research Charity

    collaborator UNKNOWN
  • Belfast Health and Social Care Trust

    lead OTHER

Principal Investigators

  • Richard Napier · Belfast Health and Social Care Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United Kingdom

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 NCT06483178 on ClinicalTrials.gov