Status:
NOT_YET_RECRUITING
Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties
Lead Sponsor:
Belfast Health and Social Care Trust
Collaborating Sponsors:
Imperial College London
Trauma and Orthopaedics Research Charity
Conditions:
Total Knee Arthroplasty
Knee Osteoarthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Detailed Description
The number of patients requiring Total Knee Arthroplasty (TKA) is increasing every year due to the combination of an aging population, increased patient expectancy, and rising levels of obesity which ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06483178
Start Date
May 1 2025
End Date
December 1 2027
Last Update
May 13 2025
Active Locations (1)
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1
Musgrave Park Hospital
Belfast, United Kingdom