Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-row repair of the Achilles tendon at its calcaneal insertion, Double-row repair of the Achilles tendon at its calcaneal insertion.
- Who it may be relevant to
- Registry conditions: Achilles Insertional Tendinopathy, Achilles Tendinopathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Single-Row Versus Double-Row Repair in the Surgical Management of Achilles Insertional Tendinopathy: A Randomized Controlled Trial (STRIDE Trial)
Overview
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.
Detailed description
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.
Interventions
- Procedure Single-row repair of the Achilles tendon at its calcaneal insertion
single-row (2 anchors) - Procedure Double-row repair of the Achilles tendon at its calcaneal insertion
double-row (4 anchors)
Primary outcome measures
- Disease-specific outcomes [Time frame: 24 months after surgery]
Secondary outcome measures (8)
- Surgical Cost [Time frame: Within 2 hours of surgery]
- Foot and Ankle Ability Measure (FAAM) [Time frame: 24 months after surgery]
- Visual Analogue Scale Foot and ankle (VAS-FA) [Time frame: 24 months after surgery]
- Plantarflexion strength [Time frame: 24 months after surgery]
- Biomechanical performance [Time frame: 24 months after surgery]
- Functional endurance [Time frame: 24 months after surgery]
- Surgical Time [Time frame: During surgery]
- TENDINopathy Severity Assessment - Achilles (TENDINS-A) [Time frame: 24 months after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Pregnancy
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Women's College Hospital — Toronto
Identifiers
NCT: NCT07323875 · CTO Study Number:5686