Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties

Sponsor
Belfast Health and Social Care Trust
Study ID
NCT06483178
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Attune knee implant — DEVICE
    Attune cementless cruciate retaining rotating platform implant (DePuy Synthes) with a standard gap balancing cruciate sacrificing surgical technique
  • Triathlon knee implant — DEVICE
    Triathlon cementless condylar stabilised implant (Stryker) with a standard gap balancing cruciate sacrificing surgical technique

Study Details

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.

Key Dates

First listed
Jul 3, 2024
Start date
May 31, 2025
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Attune
  • Active Comparator: Triathlon

Primary Outcome Measure

Post-operative top downhill walking speed at 9-12 months. [ Time Frame: 9-12 months ]

Central Contacts

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