Status:
ACTIVE_NOT_RECRUITING
Personalised Against Standard High Tibial Osteotomy
Lead Sponsor:
University of Bath
Collaborating Sponsors:
University of Oxford
3D Metal Printing Ltd
Conditions:
Medial Knee Osteoarthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A study to compare the accuracy of achieving the planned correction between personalised (TOKA) high tibial osteotomy (HTO) procedure and standard generic HTO procedure.
Detailed Description
The trial design is a multi-centre, blinded, superiority two arm, parallel group design randomised controlled trial (RCT) of personalised (TOKA) versus standard high tibial osteotomy (HTO). The aim o...
Eligibility Criteria
Inclusion
- Patients undergoing High Tibial Osteotomy
- Male or Female, aged 18 to 65 years
- Primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
- Predominately diagnosed with unicompartmental medial osteoarthritis of the knee with the normal clinically acceptable level of other compartmental involvement
- Varus deformity \<20 °
- BMI ≤ 35. An exemption to this may be made if the participant (in the investigators opinion) is suitable for surgery.
- Participant is willing and able to give informed consent for participation in the study.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Prisoners
- Participants with a known deep tissue sensitivity to device materials
- Participants with an active or suspected latent infection in or about the affected knee joint
- Participants who have received any orthopaedic surgical intervention to the lower extremities (excluding investigative surgery) within the past 12 months, or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the HTO to be enrolled in this study, within the next 12 months (including intra-articular procedures).
- Participants who require bilateral HTO with surgery planned on their second knee within 6 months of their first operation (bilateral HTO patients are otherwise included).
- Participants who require bilateral HTO who have had a previous unsuccessful contralateral partial replacement or HTO
- Chronic heart failure (NYHA Stage ≥ 2)
- Neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device
- Systemic disease diagnosis (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
- Participant is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
- Participant is a smoker.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04666571
Start Date
July 1 2021
End Date
June 29 2025
Last Update
December 16 2024
Active Locations (7)
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1
Royal United Hospitals NHS Trust
Bath, Avon, United Kingdom, BA1 3NG
2
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 7HE
3
Cardiff and Vale University Health Board
Cardiff, Wales, United Kingdom, CF14 4XW
4
Royal Orthopaedic Hospital
Birmingham, West Midlands, United Kingdom, B31 2AP