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

NCT07323875 | Not Yet Recruiting

• 1 other identifier: CTO Study Number:5686
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendinopathy; Achilles Insertional Tendinopathy

Keywords

single row repair; double row repair; calcaneal insertion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Surgical Cost

  Within 2 hours of surgery

• Foot and Ankle Ability Measure (FAAM)

  24 months after surgery

• Visual Analogue Scale Foot and ankle (VAS-FA)

  24 months after surgery

• Plantarflexion strength

  24 months after surgery

• Biomechanical performance

  24 months after surgery

Study Arms (2)

Single-row repair Arm

ACTIVE COMPARATOR

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

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

Double-row repair Arm

ACTIVE COMPARATOR

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

Interventions

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

single-row (2 anchors)

Single-row repair Arm

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

double-row (4 anchors)

Double-row repair Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: collaborator
• Unity Health Toronto: collaborator
• University of Toronto: collaborator
• The Physicians' Services Incorporated Foundation: collaborator
• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Study Officials

• Si-Hyeong Sam Park, MD, FRCPC

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didem Bozak

CONTACT

6473814051; didem.bozak@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: As noted above, only the surgeon will be aware of allocation assignment. The participant and outcomes assessors will be blinded to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MASc FRCPC

Model Details: This study is a prospective randomized controlled clinical trial of patients undergoing surgical management for chronic Achilles insertional tendinopathy.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 7, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

CA (1)