Precisión de la osteotomía Tibial Proximal Con Instrumental Paciente-específico vs técnica Convencional
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Angular precision in AP and lateral planes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Conventional surgery
Osteotomy using conventional technique
干预措施: Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques (Procedure)
Patient-specific instrumentation
Osteotomy using 3D-printed patient-specific instrumentation
干预措施: Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation (Procedure)
结局指标
主要结局
Angular precision in AP and lateral planes
时间窗: Immediate postoperative period
Difference between planned and executed angles in AP and lateral planes
Distance to joint line
时间窗: Immediate postoperative period
Difference between planned and executed distance between osteotomy cut and and joint line
次要结局
- Posterior tibial slope (PTS)(Immediate postoperative period)
- Surgical time(Day of surgery)
- Number of fluoroscopic images(Day of surgery)
- Radiation dose(Day of surgery)
- Intraoperative complications(Day of surgery)
- Postoperative complications(From surgery to end of 12 month follow-up)
- Reoperation(From surgery to end of 12 month follow-up)
- Functional recovery(From surgery to end of 12 month follow-up)
- Radiographic consolidation(From surgery until the end of the 12 month follow-up)
- Visual Analog Scale (VAS for pain)(From surgery until the end of the 12 month follow-up)
- Percentage of patients with a +-2º correction within the planned osteotomy(Immediate postoperative period)
- Timed-Up-and-Go(From surgery until the end of the 12 month follow-up)
- Balance Test (from the Short Physical Performance Battery, SPPB)(From surgery to end of 12 month follow-up)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(From surgery to end of 12 month follow-up)
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form(From surgery to end of 12 month follow-up)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(From surgery to end of 12 month follow-up)
- EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)(From surgery to end of 12 month follow-up)
- Lower Limb Functional Index (LLFI)(From surgery to end of 12 month follow-up)
- Foot Health Status Questionnaire (FHSQ)(From surgery to end of 12 month follow-up)
- Foot Function Index (FFI)(From surgery to end of 12 month follow-up)
- 5 Sit to Stand Test(From surgery until the end of the 12 month follow-up)
- Postoperative alignment (HKA angle)(Immediate postoperative period)
- Posterior tibial slope (PTS)(Immediate postoperative period)
- Surgical time(Day of surgery)
- Number of fluoroscopic images(Day of surgery)
- Radiation dose(Day of surgery)
- Intraoperative complications(Day of surgery)
- Postoperative complications(From surgery to end of 12 month follow-up)
- Reoperation(From surgery to end of 12 month follow-up)
- Functional recovery(From surgery to end of 12 month follow-up)
- Radiographic consolidation(From surgery until the end of the 12 month follow-up)
- Visual Analog Scale (VAS for pain)(From surgery until the end of the 12 month follow-up)
- Percentage of patients with a +-2º correction within the planned osteotomy(Immediate postoperative period)
- Timed-Up-and-Go(From surgery until the end of the 12 month follow-up)
- Balance Test (from the Short Physical Performance Battery, SPPB)(From surgery to end of 12 month follow-up)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(From surgery to end of 12 month follow-up)
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form(From surgery to end of 12 month follow-up)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(From surgery to end of 12 month follow-up)
- EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)(From surgery to end of 12 month follow-up)
- Lower Limb Functional Index (LLFI)(From surgery to end of 12 month follow-up)
- Foot Health Status Questionnaire (FHSQ)(From surgery to end of 12 month follow-up)
- Foot Function Index (FFI)(From surgery to end of 12 month follow-up)
研究者
Dr. Antonio I Cuesta-Vargas
Full Professor
University of Malaga