Comparative Analysis of Open Versus Arthroscopic Approaches for Subtalar Arthrodesis in Patients With Subtalar Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fusion Rate at 6 months
研究概览
简要总结
The goal of this clinical trial is to compare two surgical approaches for treating symptomatic subtalar arthritis in patients who have failed conservative treatment. The main questions it aims to answer are:
What is the fusion rate for each surgical technique? Which technique achieves bony union faster with fewer complications?
Researchers will compare arthroscopic subtalar arthrodesis (ASTA) using a combined three-to-four portal approach to open in situ subtalar arthrodesis (ISTA) to see if one technique results in superior fusion rates, faster healing, and better functional outcomes.
Participants will:
Undergo one of two surgical procedures (either ASTA or ISTA) Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery Have X-rays taken to assess fusion and bone healing Complete pain and function questionnaires at each visit
详细描述
Background and Rationale:
Subtalar arthritis is a debilitating condition frequently resulting from intra-articular calcaneal fractures, leading to progressive cartilage degeneration, hindfoot pain, and functional impairment. When conservative management fails, subtalar arthrodesis (fusion) is the established gold standard surgical treatment. Open in situ subtalar arthrodesis (ISTA) via the sinus tarsi approach has a long history of success with reported fusion rates of 85-95%. However, arthroscopic subtalar arthrodesis (ASTA) has gained popularity due to proposed advantages including preservation of blood supply, reduced soft tissue trauma, and lower wound complication rates. High-quality prospective comparative data between these two techniques remain limited.
Study Design:
Single-center, prospective, randomized controlled trial at Kasr Al-Ainy Hospitals, Cairo University. Forty patients with symptomatic subtalar arthritis are randomized 1:1 to ASTA (n=20) or ISTA (n=20) using computer-generated sequences with allocation concealment via sequentially numbered sealed opaque envelopes. Due to the nature of surgical interventions, blinding of patients and surgeons is not feasible; however, outcome assessment is performed by a blinded independent assessor.
Surgical Interventions:
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
- Single (Outcomes Assessor)
盲法说明
Due to the inherent nature of the surgical interventions, blinding of the patients and the primary surgeon was not feasible. However, the assessor responsible for collecting postoperative outcome scores was kept blinded to group assignment to minimize detection bias.
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
- •Clinically and radiographically confirmed symptomatic subtalar arthritis (post-traumatic, primary osteoarthritis, inflammatory or cured post-infective arthritis, symptomatic talocalcaneal coalition, or isolated subtalar arthrosis secondary to pes planovalgus deformity)
- •Failure of an adequate trial of non-operative treatment for a minimum of six months
- •Skeletal maturity: patients aged 18 years or older
- •Ability and willingness to provide written informed consent and to comply fully with the scheduled postoperative follow-up protocol
排除标准
- •Primary subtalar arthrodesis performed for an acute, displaced intra-articular calcaneal fracture
- •Arthrodesis planned in conjunction with other simultaneous ipsilateral hindfoot procedures
- •Patients with open physes (skeletal immaturity)
- •Indication for a distraction-type arthrodesis requiring structural bone graft
- •History of previous or current active infection at the planned operative site
- •Previous failed attempt at subtalar arthrodesis
- •Presence of significant peripheral vascular disease or other major medical comorbidities precluding safe surgical intervention
研究组 & 干预措施
Arthroscopic Subtalar Arthrodesis (ASTA)
Arthroscopic technique using a 4 mm 30° arthroscope in the prone position with a combined three-to-four portal approach (anterolateral sinus tarsi portal, posterolateral portal, posteromedial portal). Includes complete synovectomy, motorized debridement of posterior facet cartilage, subchondral microfracture drilling, and percutaneous screw fixation (two 6.5-7.3 mm cannulated screws) under fluoroscopic guidance.
干预措施: Arthroscopic Subtalar Arthrodesis (Procedure)
Open In Situ Subtalar Arthrodesis (ISTA)
Open in situ subtalar arthrodesis via the lateral sinus tarsi approach performed in the supine position. All residual articular cartilage is removed to bleeding cancellous bone. The subchondral plate is perforated to enhance fusion. Fixation is achieved with two percutaneously inserted cannulated screws under fluoroscopic guidance.
干预措施: Open In Situ Subtalar Arthrodesis (Procedure)
结局指标
主要结局
Fusion Rate at 6 months
时间窗: 6 months postoperatively
Fusion rate is defined as the proportion of patients achieving successful solid bony union of the subtalar joint. Union is determined using combined clinical and radiographic criteria, including absence of pain on palpation and passive stress, absence of detectable subtalar motion, and presence of continuous trabecular bridging across the posterior facet on plain radiographs or computed tomography when radiographs are inconclusive.
Time to Radiographic Union
时间窗: Up to 12 months postoperatively
Time to radiographic union is defined as the time elapsed from the date of surgery to the first radiographic evidence of continuous trabecular bridging across the subtalar joint fusion interface. Assessment is performed using serial plain radiographs, with computed tomography utilized when findings are equivocal.
次要结局
- Complication Rate(Intraoperative through 12 months postoperatively)
- Change in American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score(Preoperative baseline, 6 months postoperatively, and 12 months postoperatively)
- Change in Pain Intensity Measured by Visual Analog Scale (VAS)(Preoperative baseline, 6 weeks, 3 months, 6 months, 12 months postoperatively)
- Change in Short Form-12 (SF-12) Health Survey Scores(Preoperative baseline, 6 months postoperatively, 12 months postoperatively)
研究者
Helal Hosny
Orthopaedic Surgery Specialist (Doctoral Candidate)
Cairo University