Randomised Controlled Trial Comparing the Outcome of the 3D-Printed Patient-Specific-Instrument Assisted Lapidus Fusion vs Conventional Lapidus Fusion for Surgical Correction of Hallux Valgus Deformity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Foot Function
研究概览
简要总结
RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.
详细描述
Hallux valgus (HV) affects up to 30% of the population. Lapidus surgery, a combination of 1st tarsal-metatarsal joint arthrodesis is one of the most common surgical options for HV. Despite its popularity, the current method alone is not without complications. This will be the world's first Lapidus arthrodesis surgery utilising patient-specific instruments (PSI) as an assistive tool. We hypothesise that PSI will enhance surgical precision, accelerate fusion rates, decrease non-unions, and reduce the need to use bone grafts.
Methods and analysis:
This is a single-blinded, parallel-group, randomised controlled trial comparing the outcome of the 3D-Printed PSI Assisted Lapidus Fusion (n=27) vs Conventional Lapidus Fusion (n=27) for HV deformity. Both groups will receive indentical post-operative rehabilitation of protected weight bearing and splinting. Outcomes measured will include foot function scores, radiological alignment and arthrodesis site assessment with X-ray and High-Resolution Peripheral Quantitative-Computed Tomography, and foot pressure analysis.
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)
盲法说明
Outcome assessment will be performed by orthopaedic surgeons from the Foot and Ankle team; the patient and the outcome assessor will be blinded while the surgeon will not.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic Hallux Valgus
- •hallux valgus angle >20
- •1,2 Inter-metatarsal angle >9
排除标准
- •Individuals with (1) disabilities (both physical and mental) which may impair the adherence of the rehabilitation, (2) revision HV surgery, (3) concomitantly undergone additional procedures on the same foot (e.g. claw toe surgery), (4) the use of medications that may influence bone turnover (e.g. chemotherapy, osteoporotic medications) in recent 3 months, (5) medical comorbidity leading to contraindication for surgery, (6) the inability to understand written Chinese/English, (7) who are mentally/physically unable to consent will be excluded.
结局指标
主要结局
Foot Function
时间窗: 52 week
The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.
High-resolution peripheral quantitive-Computed Tomography
时间窗: 6 week
HR pQCT allows us to visualize the bony micro-architecture at the Lapidus fusion site and is a more accurate assessment of bone growth compared to X-rays. A rectangular region of interest (ROI) will be established at the fusion surface, inner callus, and external callus area. The volumetric changes in bone mineral density (BMD) in each region will be analyzed.
Time to Radiological Fusion
时间窗: 52 week
Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.
次要结局
- Non-union rate(26 week)
- Plantar pressure distribution(52 week)
- Deformity severity(52 week)
- Delayed union rate(12 week)
研究者
Samuel KK Ling
Clinical Assistant Professor
Chinese University of Hong Kong