Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque

Официальное название

Precisión de la osteotomía Tibial Proximal Con Instrumental Paciente-específico vs técnica Convencional

Обзор

This study is a randomized clinical trial that will compare two surgical techniques for patients with knee osteoarthritis and varus deformity who are candidates for medial opening wedge high tibial osteotomy. The goal is to evaluate whether using patient-specific 3D-printed surgical guides improves the accuracy of the bone cut compared with the conventional technique performed with anatomical landmarks and fluoroscopy. A total of 50 adult patients will be randomly assigned to one of two groups: conventional osteotomy or osteotomy assisted by patient-specific instrumentation (PSI). The main outcome is the accuracy of the osteotomy cut, measured by comparing preoperative planning with the postoperative CT scan. Secondary outcomes include leg alignment, surgical time, radiation exposure, complications, and functional recovery assessed with validated questionnaires (KOOS, WOMAC, IKDC, EQ-5D) and gait analysis using depth cameras. Patients will be followed for up to 12 months after surgery to evaluate clinical and radiological outcomes.

Подробное описание

Medial opening wedge high tibial osteotomy is a well-established surgical procedure to correct knee alignment in patients with medial knee osteoarthritis and varus deformity. The accuracy of the bone cut is critical for surgical success. However, conventional techniques performed with anatomical landmarks and fluoroscopy may result in variability and suboptimal correction.

Recent advances in 3D imaging and printing allow the creation of patient-specific surgical guides designed from preoperative CT scans. These guides may improve the accuracy and reproducibility of the osteotomy.

This single-center randomized clinical trial will include 50 adult patients, randomly assigned to undergo conventional osteotomy or osteotomy assisted by patient-specific instrumentation. The main outcome is the accuracy of the osteotomy cut compared with preoperative planning. Secondary outcomes include leg alignment, surgical efficiency, radiation exposure, complications, and functional recovery. Patients will be followed for 12 months.

Вмешательства

• Процедура Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation
  Medial Open Wedge Hight Tibial Osteotomy using 3D printed patient-specific instrumentation as a guide for the osteotomy
• Процедура Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques
  Conventional Medial Open Wedge Hight Tibial Osteotomy

Первичные конечные точки

• Angular precision in AP and lateral planes [Срок оценки: Immediate postoperative period]
• Distance to joint line [Срок оценки: Immediate postoperative period]

Вторичные конечные точки (12)

• Postoperative alignment (HKA angle) [Срок оценки: Immediate postoperative period]
• Posterior tibial slope (PTS) [Срок оценки: Immediate postoperative period]
• Surgical time [Срок оценки: Day of surgery]
• Number of fluoroscopic images [Срок оценки: Day of surgery]
• Radiation dose [Срок оценки: Day of surgery]
• Intraoperative complications [Срок оценки: Day of surgery]
• Postoperative complications [Срок оценки: From surgery to end of 12 month follow-up]
• Reoperation [Срок оценки: From surgery to end of 12 month follow-up]
• Functional recovery [Срок оценки: From surgery to end of 12 month follow-up]
• Radiographic consolidation [Срок оценки: From surgery until the end of the 12 month follow-up]
• 5 Sit to Stand Test [Срок оценки: From surgery until the end of the 12 month follow-up]
• Visual Analog Scale (VAS for pain) [Срок оценки: From surgery until the end of the 12 month follow-up]

Критерии участия

Критерии включения

• Informed consent: able to sign informed consent
• Clinical: predominantly medial pain/limitation refractory ≥3-6 months
• Mobility: flexion ≥90º and flexion contracture ≤10º Stability: varus/valgus and pivot-shift ≤ grade 1.
• Radiology:

• Medial gonarthrosis Ahlbäck I-III with preserved lateral compartment.
• Patellofemoral Iwano 0-2 without disabling patellofemoral pain.
• Varus alignment: HKA 4-10°.
• Predominantly tibial deformity (decreased MPTA; LDFA close to normal) according to planning.
• Anatomy/technical feasibility: proximal tibial morphology suitable for medial opening osteotomy and PSI guide placement.

Критерии исключения

• Comorbidity/clinical situations:

• Inflammatory arthritis (e.g., RA, spondyloarthropathies), unresolved previous joint infection or osteomyelitis.
• Severe peripheral vasculopathy (ABI <0.7), advanced peripheral neuropathy or Charcot foot.
• Poorly controlled diabetes (HbA1c >8.5%), advanced renal/hepatic failure (eGFR <30 ml/min/1.73 m²; Child-Pugh B/C).
• Smoking >20 cigarettes/day without commitment to cessation; active IV drug use or uncontrolled alcoholism.
• BMI >35 kg/m².
• Disorder affecting gait (e.g., neurological disease).
• Inability to walk at a speed of at least 0.8m/s
• Anatomy/radiology

• Multiplanar deformities not correctable with isolated medial opening tibial valgus osteotomy (e.g., dominant femoral deformity).
• Severe medial subchondral bone defect or extensive necrosis.
• Sequelae of proximal tibia fracture or previous ipsilateral HTO that prevent correction or guide use.
• Treatments/medication and logistics

• Anticoagulation/antiplatelet therapy that cannot be suspended or bridged.
• Systemic corticosteroids >10 mg/day or high-risk immunosuppressants without possibility of adjustment.
• Intra-articular infiltration (HA/CS/PRP) within the previous 60 days (respect defined wash-out).
• Pregnancy.
• Participation in another interfering trial.
• Inability to undergo CT (e.g., uncontrollable claustrophobia).
• Inability to complete ≥12 months of follow-up.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario Virgen de la Victoria de Málaga — Málaga

Публикации

• Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923. PMID 21205966
• Jacquet C, Sharma A, Fabre M, Ehlinger M, Argenson JN, Parratte S, Ollivier M. Patient-specific high-tibial osteotomy's 'cutting-guides' decrease operating time and the number of fluoroscopic images taken after a Brief Learning Curve. Knee Surg Sports Traumatol Arthrosc. 2020 Sep;28(9):2854-2862. doi: 10.1007/s00167-019-05637-6. Epub 2019 Jul 27. PMID 31352498
• Pang R, Jiang Z, Xu C, Shi W, Zhang X, Wan X, Bahat D, Li H, Senatov F, Bulygina I, Wang H, Zhang H, Li Z. Is Patient-Specific Instrumentation Accurate and Necessary for Open-Wedge High Tibial Osteotomy? A Meta-Analysis. Orthop Surg. 2023 Feb;15(2):413-422. doi: 10.1111/os.13483. Epub 2022 Dec 30. PMID 36585795
• Zhu X, Qian Y, Liu A, Xu P, Guo JJ. Comparative outcomes of patient-specific instrumentation, the conventional method and navigation assistance in open-wedge high tibial osteotomy: A prospective comparative study with a two-year follow up. Knee. 2022 Dec;39:18-28. doi: 10.1016/j.knee.2022.08.013. Epub 2022 Sep 14. PMID 36115179
• Cerciello S, Ollivier M, Corona K, Kaocoglu B, Seil R. CAS and PSI increase coronal alignment accuracy and reduce outliers when compared to traditional technique of medial open wedge high tibial osteotomy: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):555-566. doi: 10.1007/s00167-020-06253-5. Epub 2020 Sep 10. PMID 32910222
• Carey EG, Kamath AF, Vidal AF, Frush T, Alaia M, Baldwin RB, Ranawat A. Assessing the Impact of Patient-Specific Instrumentation and Fixation on Accuracy and Radiation Exposure in a Cadaveric Model of Medial Opening-Wedge High Tibial Osteotomy. Orthop J Sports Med. 2025 Jan 28;13(1):23259671241285430. doi: 10.1177/23259671241285430. eCollection 2025 Jan. PMID 39881858
• Miao Z, Li S, Luo D, Lu Q, Liu P. The validity and accuracy of 3D-printed patient-specific instruments for high tibial osteotomy: a cadaveric study. J Orthop Surg Res. 2022 Jan 29;17(1):62. doi: 10.1186/s13018-022-02956-2. PMID 35093132
• Chaouche S, Jacquet C, Fabre-Aubrespy M, Sharma A, Argenson JN, Parratte S, Ollivier M. Patient-specific cutting guides for open-wedge high tibial osteotomy: safety and accuracy analysis of a hundred patients continuous cohort. Int Orthop. 2019 Dec;43(12):2757-2765. doi: 10.1007/s00264-019-04372-4. Epub 2019 Jul 5. PMID 31273430

Идентификаторы

NCT: NCT07212777 · 2025999010604889

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗