Removal of metalwork following high tibial osteotomy: A randomised controlled trial comparing removal of metalwork rates for the ActivMotion (Newclip) and Tomofix (Synthes) high tibial osteotomy plates

orth Bristol NHS Trust0 个研究点目标入组 40 人开始时间: 2020年3月18日最近更新: 2023年11月28日

适应症

试验速览

暂无简介。

•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

•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

发起方

orth Bristol NHS Trust