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Search / Trial NCT06483178

Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties

Launched by BELFAST HEALTH AND SOCIAL CARE TRUST · Jun 25, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two types of knee implants, the Attune and the Triathlon, to see which one leads to better walking and overall outcomes for patients undergoing knee replacement surgery. As more people need knee replacements due to conditions like arthritis and aging, it's important to find the best options available. The Attune knee is newer, while the Triathlon has been used successfully for many years. Researchers will analyze how well each implant works by looking at patients' walking patterns and their own reports about how they feel after surgery.

To participate in this study, you should be between 65 and 74 years old and need a knee replacement due to arthritis that affects the inner part of your knee. You should be able to walk at a good speed and manage daily activities without too much assistance. If you join the study, you will be randomly assigned to receive either the Attune or Triathlon knee implant. Throughout the trial, there will be regular check-ins to assess your walking ability and recovery. It's also important to note that you’ll need a smartphone to complete online questionnaires as part of the study. Overall, this trial aims to help improve knee replacement surgeries and patient experiences.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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).

About Belfast Health And Social Care Trust

Belfast Health and Social Care Trust is a leading healthcare organization in Northern Ireland, dedicated to delivering high-quality patient care and advancing medical research. As a prominent clinical trial sponsor, the Trust plays a pivotal role in facilitating innovative research studies that aim to improve treatment outcomes and enhance the understanding of various health conditions. With a commitment to ethical practices and patient safety, Belfast Health and Social Care Trust collaborates with multidisciplinary teams to ensure rigorous trial protocols and adherence to regulatory standards, ultimately contributing to the advancement of healthcare solutions and the betterment of community health.

Locations

Belfast, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Richard Napier

Principal Investigator

Belfast Health and Social Care Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported