Single-Row Versus Double-Row Repair in the Surgical Management of Achilles Insertional Tendinopathy: A Randomized Controlled Trial (STRIDE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Disease-specific outcomes
研究概览
简要总结
Achilles insertional tendinopathy may require surgical debridement and tendon reattachment when non-operative treatment fails. Single-row and double-row repairs are used, with biomechanical studies favoring double-row, but clinical evidence of improved outcomes is lacking and costs are higher. This multi-center randomized trial will use the VISA-A score to compare outcomes and inform cost-effective, evidence-based surgical care.
详细描述
Double-row repairs for Achilles insertional tendinopathy have been shown biomechanically to be stronger than single-row repairs, but clinical studies have not demonstrated clear advantages. Existing comparative studies are limited by retrospective designs and use of non-validated outcome measures such as AOFAS, VAS, and SF-36 Physical Function. No prospective randomized trials have evaluated clinical outcomes of single-row versus double-row repairs.
This multi-center randomized controlled trial will use the disease-specific Victorian Institute of Sports Assessment-Achilles (VISA-A) score to compare clinical outcomes between single-row and double-row repairs, providing high-quality evidence to guide optimal surgical management.
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
As noted above, only the surgeon will be aware of allocation assignment. The participant and outcomes assessors will be blinded to minimize bias.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be deemed to have capacity to provide informed consent;
- •Must sign and date the informed consent form;
- •Stated willingness to comply with all study procedures;
- •Adult patients between the ages of 18 and 75 years with symptomatic chronic Achilles insertional tendinopathy for a minimum of 3 months
- •Failure of non-operative management (which includes physiotherapy, stretching exercises, heel lifts, nonsteroidal anti-inflammatory drugs (NSAIDs), activity modification, etc.) for at least 3 months.
- •Preoperative imaging (x-ray and Medical Resonance Imaging (MRI)) is available and completed;
- •Willingness of patients to follow the postoperative rehabilitation protocol;
- •Willingness of patients to be available for follow up appointments for up to 2 years.
排除标准
- •Non-insertional Achilles tendinopathy;
- •Achilles tendon rupture;
- •Previous Achilles tendon surgery;
- •Oral steroid use or steroid injection within 3 months of surgery;
- •History of connective tissue or collagen disorder (e.g. Marfan Syndrome)
- •History of chronic inflammatory disorders
- •History of neurological disease (stroke, cerebral palsy)
- •History of using more than 30mg of oxycodone or equivalent per day;
- •Current cigarette smoker (Former smokers must have quit for minimum of one year)
- •Diabetes type I or II
- •Hypersensitivity to metal, Polylactic Acid (PLA), or Polyetheretherketone (PEEK) materials
- •Active infection
- •Worker's compensation claim (e.g. WSIB)
- •History of cognitive or mental health conditions that would make the participant unable to complete study procedures
- •Non-English speaking
研究组 & 干预措施
Double-row repair Arm
Double-row repair will involve 2 suture anchors for the proximal row and 2 suture anchors for the distal row (4 anchors total)
干预措施: Double-row repair of the Achilles tendon at its calcaneal insertion (Procedure)
Single-row repair Arm
Single-row repair will involve 2 suture anchors (2 anchors total)
干预措施: Single-row repair of the Achilles tendon at its calcaneal insertion (Procedure)
结局指标
主要结局
Disease-specific outcomes
时间窗: 24 months after surgery
The Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire is a validated, self-reported outcome measure designed to assess the severity of Achilles tendinopathy. It evaluates three key domains: pain, function, and activity level and produces a score from 0 to 100, with higher scores indicating better function and fewer symptoms.
次要结局
- TENDINopathy Severity Assessment - Achilles (TENDINS-A)(24 months after surgery)
- Surgical Cost(Within 2 hours of surgery)
- Foot and Ankle Ability Measure (FAAM)(24 months after surgery)
- Visual Analogue Scale Foot and ankle (VAS-FA)(24 months after surgery)
- Plantarflexion strength(24 months after surgery)
- Biomechanical performance(24 months after surgery)
- Functional endurance(24 months after surgery)
- Surgical Time(During surgery)