Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBelfast Health and Social Care Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged <65 years old who require a primary TKA for medial compartment osteoarthritis with a varus deformity.

On examination patients must have a pain free ROM of both hips, both ankles and the opposite knee. A history of mild pain in any of these lower limb joints that does not inhibit mobility is acceptable.

Must be able to walk at a pre-operative speed of at least 4 km/h (approximately 30 metres in 30 seconds).

Must be able to walk outside unaided or with no more than a walking stick.

Disqualifiers

Patients with valgus deformity of the knee.

Patients with previous lower limb arthroplasty.

Patients with previous lower limb open reduction and internal fixation (ORIF).

Patients who are American Society of Anaesthesiologists (ASA) grade 3 or higher.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: AttuneExperimental treatment 1 intervention
Group B: TriathlonActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative top downhill walking speed at 9-12 months.

Post-operative top downhill walking speed at 9-12 months will be assessed via gait analysis.

Time frame
9-12 months

Secondary outcomes

1

Ground reaction forces in the vertical plane throughout the stance phase of the gait cycle.

Time frame
9-12 months
2

Ground reaction forces in the medio lateral plane throughout the stance phase of the gait cycle.

Time frame
9-12 months
3

Ground reaction forces in the anterior posterior plane throughout the stance phase of the gait cycle.

Time frame
9-12 months
4

Gait symmetry at weight acceptance (heel strike) of the stance phase

Time frame
9-12 months

Other outcomes

Sponsors and contacts

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Belfast Health and Social Care Trust

Lead sponsor

Imperial College London

Collaborator

Trauma and Orthopaedics Research Charity

Collaborator

This trial is not recruiting at the moment. You can still explore other options: