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

NCT ID: NCT07323875

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2030-03-31

Brief Summary

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.

Conditions

Achilles Insertional Tendinopathy; Achilles Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single-row repair Arm

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

single-row (2 anchors)

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

double-row (4 anchors)

Interventions

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

single-row (2 anchors)

Intervention Type: PROCEDURE

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

double-row (4 anchors)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sam Park

MD MASc FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Si-Hyeong Sam Park, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Didem Bozak

Role: CONTACT

didem.bozak@wchospital.ca

6473814051

Other Identifiers

CTO Study Number:5686

Identifier Type: -

Identifier Source: org_study_id