Recruiting

Surgical Repair

Sponsor:

Women's College Hospital

Code:

NCT07323875

Conditions

Achilles Insertional Tendinopathy

Achilles Tendinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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 Insertional Tendinopathy

Achilles Tendinopathy

Study ID

NCT07323875

Start date

Aug 12, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

166 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Single-row repair Arm

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

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)

Interventions

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

single-row (2 anchors)

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

double-row (4 anchors)

Primary outcome measure

  • Disease-specific outcomes [ Time Frame: 24 months after surgery ]

Central Contacts and Locations

Central contacts

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

More Information

Sponsor

Women's College Hospital

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • single row repair
  • double row repair
  • calcaneal insertion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.