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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
| University Health Network, Toronto | OTHER |
| Unity Health Toronto | OTHER |
| University of Toronto |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-row repair Arm | Active Comparator | Single-row repair will involve 2 suture anchors (2 anchors total) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-row repair of the Achilles tendon at its calcaneal insertion | Procedure | single-row (2 anchors) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Cost | Assess the cost difference between single-row repair versus double-row repair | Within 2 hours of surgery |
| Foot and Ankle Ability Measure (FAAM) | The FAAM is a patient-reported outcome questionnaire designed to assess physical function in individuals with foot and ankle disorders. Scores are typically expressed as percentages, with higher scores indicating better function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Didem Bozak | Contact | 6473814051 | didem.bozak@wchospital.ca |
| Name | Affiliation | Role |
|---|---|---|
| Si-Hyeong Sam Park, MD, FRCPC | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
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| OTHER |
This study is a prospective randomized controlled clinical trial of patients undergoing surgical management for chronic Achilles insertional tendinopathy.
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As noted above, only the surgeon will be aware of allocation assignment. The participant and outcomes assessors will be blinded to minimize bias.
| Double-row repair of the Achilles tendon at its calcaneal insertion | Procedure | double-row (4 anchors) |
|
| 24 months after surgery |
| Visual Analogue Scale Foot and ankle (VAS-FA) | The VAS-FA is a patient-reported outcome measure designed to assess pain, function, and other symptoms related to foot and ankle disorders. It uses a visual analogue scale, typically a 100 mm line, where patients indicate the severity of their symptoms. Higher scores usually indicate better function or less pain. | 24 months after surgery |
| Plantarflexion strength | Measured using a HUMAC Norm Isokinetic Dynamometer Weakness: May indicate calf muscle atrophy, nerve injury, or Achilles tendon dysfunction. Deficits: Can cause altered gait, decreased push-off, and balance problems. | 24 months after surgery |
| Biomechanical performance | Including ankle kinematics and kinetics during gait and functional tasks, assessed through markerless motion tracking. Gait Analysis: Evaluating walking or running patterns in patients with musculoskeletal or neurological impairments. | 24 months after surgery |
| Functional endurance | As measured by the Heel Rise Test Normal: Able to perform ≥25-30 single-leg heel raises with minimal fatigue. Weakness: Fewer repetitions or lower heel height may suggest calf muscle weakness. | 24 months after surgery |
| Surgical Time | Assess the operative time required for single-row repair versus double-row repair. | During surgery |
| TENDINopathy Severity Assessment - Achilles (TENDINS-A) | A validated patient-reported outcome measure assessing pain, symptoms, and functional limitations associated with Achilles tendinopathy. Higher scores indicate greater disability and symptom severity. | 24 months after surgery |