High tibial osteotomy (HTO) for knee realignment Surgery
Conditions
Interventions
This is a randomised controlled trial comparing two high tibial osteotomy plates - both currently used in standard practice and both CE marked. The research nurses working on the study will follow a
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Standing varus malalignment benefitting from high tibial osteotomy correction 2. Diagnosed with current osteoarthritis of the knee 3. Aged over 18 and under 65 years 4. Candidate to be implanted with a Tomofix or ActivMotion plate 5. Understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements 6. Has signed informed consent for the use of their personal private data
Exclusion criteria
Exclusion criteria: 1. Has declined to sign informed consent for the use of their person /private data 2. Correction greater than 14 mm opening wedge 3. Flexion contracture greater than 15° 4. Knee flexion under 90° 5. Medial/lateral tibial subluxation over 1 cm 6. Medial bone loss of over 3 mm 7. Inflammatory arthritis 8. Arthritis in the lateral compartment 9. Patella baja 10. Weight over 110 kg 11. Severe patellofemoral symptoms 12. Unaddressed ligamentous instability 13. Fixed flexion contracture 14. Known or suspected osteoporosis or osteopenia based on medical history and radiographic images 15. Current use of nicotine products. 16. Requires other surgical procedures at the time of the HTO surgery excluding arthroscopic exploration, chondroplasty, meniscectomy and cartilage preservation procedures 17. Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants requiring removal of plate or listed for plate removal within 2 years of surgery assessed using a questionnaire posted to participants | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain assessed using a visual analogue score (VAS) at 1-5 days, 2 weeks, 6 weeks and 1 year post-operatively 2. Pain associated with knee osteoarthritis assessed using the Knee Osteoarthritis Outcome Score (KOOS) score at baseline and 1 year 3. Knee function assessed using the KOOS score at baseline and 1 year 4. Quality of life related to knee problems assessed using the KOOS score at baseline and 1 year 5. Wound size assessed using the measurements of the circumference of the limb and the wound incisions taken at the time of surgery. | — |
Countries
England, United Kingdom
Contacts
Public ContactCorina Negrut
Outcome results
None listed