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

Women's College Hospital

Status: Not yet enrolling

Conditions: Achilles Insertional Tendinopathy; Achilles Tendinopathy

Treatments: Procedure: Double-row repair of the Achilles tendon at its calcaneal insertion; Procedure: Single-row repair of the Achilles tendon at its calcaneal insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT07323875

CTO Study Number:5686

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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166 participants in 2 patient groups

Single-row repair Arm

Active Comparator group

Description:

Single-row repair will involve 2 suture anchors (2 anchors total)

Treatment:

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

Double-row repair Arm

Active Comparator group

Description:

Double-row repair will involve 2 suture anchors for the proximal row and 2 suture anchors for the distal row (4 anchors total)

Treatment:

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