Personalised Against Standard High Tibial Osteotomy, a Prospective Multi-centre Randomised Controlled Trial

Status: Active_not_recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Royal United Hospitals NHS Trust
Bath
Royal Orthopaedic Hospital
Birmingham
Cardiff and Vale University Health Board
Cardiff
Royal Devon and Exeter NHS Foundation Trust
Exeter
Oxford University Hospitals NHS Trust
Oxford
Great Western Hospital
Swindon
Walsall Manor Hospital
Walsall
Time Frame
Start Date: 2021-07-01
Completion Date: 2025-06-29
Participants
Target number of participants: 56
Treatments
Experimental: Personalised (TOKA)
During HTO surgery, the personalised plate will be inserted below the knee.~The investigational device and comparator are two types of metal plate used to fix the bone in place during a high tibial osteotomy (HTO).
Active_comparator: Standard (Tomofix or ActivMotion)
During HTO surgery, the standard plate will be inserted below the knee.
Related Therapeutic Areas
Sponsors
Collaborators: 3D Metal Printing Ltd, Versus Arthritis, University of Oxford
Leads: University of Bath

This content was sourced from clinicaltrials.gov