Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy (STRIDE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Achilles Tendinopathy; Achilles Insertional Tendinopathy
• Intervention / Treatment: Procedure: Single-row repair of the Achilles tendon at its calcaneal insertion; Procedure: Double-row repair of the Achilles tendon at its calcaneal insertion

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.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Didem Bozak; Phone Number: 6473814051; Email: didem.bozak@wchospital.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must be deemed to have capacity to provide informed consent;
2. Must sign and date the informed consent form;
3. Stated willingness to comply with all study procedures;
4. Adult patients between the ages of 18 and 75 years with symptomatic chronic Achilles insertional tendinopathy for a minimum of 3 months
5. 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.
6. Preoperative imaging (x-ray and Medical Resonance Imaging (MRI)) is available and completed;
7. Willingness of patients to follow the postoperative rehabilitation protocol;
8. Willingness of patients to be available for follow up appointments for up to 2 years.

Exclusion Criteria:

1. Non-insertional Achilles tendinopathy;
2. Achilles tendon rupture;
3. Previous Achilles tendon surgery;
4. Oral steroid use or steroid injection within 3 months of surgery;
5. History of connective tissue or collagen disorder (e.g. Marfan Syndrome)
6. History of chronic inflammatory disorders
7. History of neurological disease (stroke, cerebral palsy)
8. History of using more than 30mg of oxycodone or equivalent per day;
9. Current cigarette smoker (Former smokers must have quit for minimum of one year)
10. Diabetes type I or II
11. Pregnancy
12. Hypersensitivity to metal, Polylactic Acid (PLA), or Polyetheretherketone (PEEK) materials
13. Active infection
14. Worker's compensation claim (e.g. WSIB)
15. History of cognitive or mental health conditions that would make the participant unable to complete study procedures
16. Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single-row repair Arm; Single-row repair will involve 2 suture anchors (2 anchors total)	Procedure: Single-row repair of the Achilles tendon at its calcaneal insertion; single-row (2 anchors)
Active Comparator: 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)	Procedure: Double-row repair of the Achilles tendon at its calcaneal insertion; double-row (4 anchors)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific outcomes	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.	24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Cost	Assess the cost difference between single-row repair versus double-row repair	Within 2 hours of surgery
Foot and Ankle Ability Measure (FAAM)	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.	24 months after surgery
Visual Analogue Scale Foot and ankle (VAS-FA)	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.	24 months after surgery
Plantarflexion strength	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.	24 months after surgery
Biomechanical performance	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.	24 months after surgery
Functional endurance	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.	24 months after surgery
Surgical Time	Assess the operative time required for single-row repair versus double-row repair.	During surgery

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: University Health Network, Toronto; Unity Health Toronto; University of Toronto; The Physicians' Services Incorporated Foundation
• Investigators: Principal Investigator: Si-Hyeong Sam Park, MD, FRCPC, Women's College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: single row repair; double row repair; calcaneal insertion
• Other Study ID Numbers: CTO Study Number:5686

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No