Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWomen's College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Non-insertional Achilles tendinopathy;
Achilles tendon rupture;
Previous Achilles tendon surgery;
Oral steroid use or steroid injection within 3 months of surgery;
Trial design
Design model
Parallel
Treatments tested in this trial
Single-row repair of the Achilles tendon at its calcaneal insertion
Procedure/Surgerysingle-row (2 anchors)
Double-row repair of the Achilles tendon at its calcaneal insertion
Procedure/Surgerydouble-row (4 anchors)
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Single-row repair ArmActive comparator 1 intervention
Group B: Double-row repair ArmActive comparator 1 intervention
Trial outcomes
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.
Time frame
24 months after surgerySecondary outcomes
1
Surgical Cost
Assess the cost difference between single-row repair versus double-row repair
Time frame
Within 2 hours of surgery2
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.
Time frame
24 months after surgery3
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.
Time frame
24 months after surgery4
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.
Time frame
24 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Women's College Hospital
Lead sponsor
The Physicians' Services Incorporated Foundation
Collaborator
University Health Network, Toronto
Collaborator
Unity Health Toronto
Collaborator
University of Toronto
Collaborator
Source ClinicalTrials.gov