Comparing two high tibial osteotomy plates in terms of pain and plate removal

Not Applicable

• Conditions: High tibial osteotomy (HTO) for knee realignment; Surgery

• Registration Number: ISRCTN34155545
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-18
• Last Update Posted: 28 November 2023
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Pain assessed using a visual analogue score (VAS) at 1-5 days, 2 weeks, 6 weeks and 1 year post-operatively<br>2. Pain associated with knee osteoarthritis assessed using the Knee Osteoarthritis Outcome Score (KOOS) score at baseline and 1 year<br>3. Knee function assessed using the KOOS score at baseline and 1 year<br>4. Quality of life related to knee problems assessed using the KOOS score at baseline and 1 year<br>5. Wound size assessed using the measurements of the circumference of the limb and the wound<br>incisions taken at the time of surgery.