Single-row versus double-row repair for Achilles insertional tendinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares single-row and double-row surgical repairs of the Achilles tendon at its calcaneal insertion in adults with chronic insertional tendinopathy who have failed non-operative care. Outcomes will be measured using the VISA-A score to determine which technique provides better functional results. The study addresses a gap in prospective, randomized evidence and will inform cost-effective surgical decisions based on patient-centered outcomes. Biomechanical advantages of double-row repairs seen in lab studies have not yet translated into clear clinical benefits in prior research. The trial includes follow-up for up to two years to capture longer-term outcomes and rehabilitation effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Women's College Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Si-Hyeong Sam Park, MD, FRCPC — Women's College Hospital
• Study coordinator: Didem Bozak
• Email: didem.bozak@wchospital.ca
• Phone: 6473814051

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.