Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties

NCT06483178 | Not Yet Recruiting

• 1 other identifier: 21057RN-SW
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Total Knee Arthroplasty; Knee Osteoarthritis

Outcome Measures

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.

  9-12 months

Secondary Outcomes (20)

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

  9-12 months

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

  9-12 months

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

  9-12 months

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

  9-12 months

• Gait symmetry at mid-stance of the stance phase

  9-12 months

Study Arms (2)

Attune

EXPERIMENTAL

Device: Attune knee implant

Triathlon

ACTIVE COMPARATOR

Device: Triathlon knee implant

Interventions

Attune knee implant DEVICE

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

Attune

Triathlon knee implant DEVICE

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

Triathlon

Eligibility Criteria

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

You may qualify if:

• 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.
• Must be able to complete pre- and post-operative gait analysis.
• Participants must have a functional level of spoken and written English and must have a smartphone or have access to a smartphone to complete the online questionnaires on REDCap and to take photographs for virtual assessment of ROM.

You may not qualify if:

• 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.
• Patients who are unable to adhere to the trial protocol (due to cognitive impairment, cannot speak English or for any other reason).

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Imperial College London: collaborator
• Trauma and Orthopaedics Research Charity: collaborator

Study Sites (1)

Musgrave Park Hospital

Belfast, United Kingdom

Location

Related Publications (34)

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Related Links

• National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 17th Annual Report. (2020). Table 3.25 (a).
• Australian Orthopaedic Association National Joint Replacement Registry Annual Report. (2020). Tables KT7.
• Funk DA, Bridgens J. Confidence in the ATTUNE Knee is Driven by Real World Scientific Evidence: Response to Bonutti, et al. Article. (2017).
• Stryker. Triathlon Total Knee System.
• Clary, C. Attune Knee System: Stability in Total Knee Replacement. DePuy Synthes Joint Reconstruction.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Richard Napier

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Gallagher

CONTACT

02895043746; nicola.gallagher@belfasttrust.hscni.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single centred, parallel group, randomised controlled trial

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: July 3, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)