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NCT Number: NCT07323875

Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy

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.

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Key information

Conditions

Achilles Insertional Tendinopathy Achilles Tendinopathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-row repair of the Achilles tendon at its calcaneal insertion

Procedure

single-row (2 anchors)

Double-row repair of the Achilles tendon at its calcaneal insertion

Procedure

double-row (4 anchors)

Primary outcomes

  1. Disease-specific outcomes

    Time frame: 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.

Secondary outcomes

  1. Surgical Cost

    Time frame: Within 2 hours of surgery

    Assess the cost difference between single-row repair versus double-row repair

  2. Foot and Ankle Ability Measure (FAAM)

    Time frame: 24 months after surgery

    The FAAM is a patient-reported outcome questionnaire designed to assess physical function in individuals with foot and ankle disorders.

    Scores are typically expressed as percentages, with higher scores indicating better function.

  3. Visual Analogue Scale Foot and ankle (VAS-FA)

    Time frame: 24 months after surgery

    The VAS-FA is a patient-reported outcome measure designed to assess pain, function, and other symptoms related to foot and ankle disorders. It uses a visual analogue scale, typically a 100 mm line, where patients indicate the severity of their symptoms. Higher scores usually indicate better function or less pain.

  4. Plantarflexion strength

    Time frame: 24 months after surgery

    Measured using a HUMAC Norm Isokinetic Dynamometer Weakness: May indicate calf muscle atrophy, nerve injury, or Achilles tendon dysfunction.

    Deficits: Can cause altered gait, decreased push-off, and balance problems.

  5. Biomechanical performance

    Time frame: 24 months after surgery

    Including ankle kinematics and kinetics during gait and functional tasks, assessed through markerless motion tracking.

    Gait Analysis: Evaluating walking or running patterns in patients with musculoskeletal or neurological impairments.

  6. Functional endurance

    Time frame: 24 months after surgery

    As measured by the Heel Rise Test

    Normal: Able to perform ≥25-30 single-leg heel raises with minimal fatigue. Weakness: Fewer repetitions or lower heel height may suggest calf muscle weakness.

  7. Surgical Time

    Time frame: During surgery

    Assess the operative time required for single-row repair versus double-row repair.

  8. TENDINopathy Severity Assessment - Achilles (TENDINS-A)

    Time frame: 24 months after surgery

    A validated patient-reported outcome measure assessing pain, symptoms, and functional limitations associated with Achilles tendinopathy. Higher scores indicate greater disability and symptom severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Didem Bozak

CONTACT

[email protected]

6473814051

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • The Physicians' Services Incorporated Foundation
  • Unity Health Toronto
  • University Health Network, Toronto
  • University of Toronto

Registry information

Official study title

Single-Row Versus Double-Row Repair in the Surgical Management of Achilles Insertional Tendinopathy: A Randomized Controlled Trial (STRIDE Trial)

Acronym: STRIDE

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jan 7, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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