Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments. A Randomized Stratified Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety.
研究概览
简要总结
Primary Objective:
To clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety. The clinical AOFAS scale will be used for assessment.
Secondary Objectives:
To determine if there are differences in health outcomes and patient-perceived pain using the specific SP-36 scale and verbal numeric rating scale (VNRS). Additionally, to assess differences in postoperative complication rates and time to return to daily life activities between the two surgical techniques.
Study Design:
Prospective, randomized, controlled clinical trial with two parallel groups stratified by age and functional demand.
Condition or Disorder Being Studied:
Chronic lateral ankle instability.
Study Population and Sample Size:
The target population includes subjects diagnosed with chronic lateral ankle instability. The study population consists of patients diagnosed in the Orthopedics consultations at Hospital Infanta Elena who meet the inclusion and exclusion criteria. Based on sample size calculations, a total of 36 patients will be recruited. However, due to the prospective nature and stratification by epidemiological and functional variables, the sample size may be increased to ensure comparable groups in each stratum.
Study Timeline and Estimated Completion Date:
The study is expected to begin in the third quarter of 2025. Recruitment is estimated to last 24 months, with a follow-up period of 12 months, for a total duration of 3 years, ending in the third quarter of 2028.
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)
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
- •Mandatory criteria (all must be marked "yes" in a drop-down tab):
- •Age >18 years
- •Subjective sensation of instability
- •Pathological anterior drawer and varus tilt compared to the contralateral side
- •Magnetic resonance imaging showing lesion of the anterior talofibular ligament (ATFL)
- •Specific criteria (must meet at least one, but can meet several, multiple choice option):
- •High athletic demand (regularly participates in pivoting sports)
- •Ligamentous hyperlaxity (Beighton score >8)
- •First sprain more than 2 years ago
- •More than 5 sprains per year
- •Subfibular ossicle >1 cm
- •MRI with ATFL showing high T2 signal
- •MRI showing disruption/absence of ATFL
排除标准
- •History of previous ankle surgery
- •Tibiotalar osteoarthritis or presence of chondral lesions on magnetic resonance imaging
- •Active infections
- •Contraindications for surgery
- •Pregnancy
- •Lactation
- •Known allergy to bovine collagen
- •Autoimmune connective tissue disease
- •Active oncological process
结局指标
主要结局
Clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety.
时间窗: From surgery to the end of the follow up at 12 months after surgery
Clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety. For this purpose, the clinical AOFAS (American Orthopedics Foot and Ankle Score) score will be used. The minimum value for the AOFAS score is 0 and the maximum value is 100. Higher scores on the AOFAS scale indicate a better outcome, meaning less pain, better function, and improved alignment.
次要结局
- Determine whether there are differences in health outcomes(From surgery to the end of the follow up at 12 months after surgery)
- Determine whether there are differences in patient-perceived pain(From surgery to the end of the follow up at 12 months after surgery)
- Determine whether there are differences between both groups in the rate of postoperative complications.(From surgery to the end of the follow up at 12 months after surgery)
- Determine whether there are differences in time to return to normal life between the two surgical techniques.(From surgery to the end of the follow up at 12 months after surgery)
研究者
Juan Chans Veres
Attending Physician, Foot and Ankle Unit, Department of Orthopaedic Surgery
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz