Achilles Insertional TendinopathySTRIDENCT07323875
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
A study testing Single-row repair of the Achilles tendon at its calcaneal insertion and Double-row repair of the Achilles tendon at its calcaneal insertion in people with Achilles Insertional Tendinopathy and Achilles Tendinopathy, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Insertional Tendinopathy, Achilles Tendinopathy
- What is being tested?
- Single-row repair of the Achilles tendon at its calcaneal insertion and Double-row repair of the Achilles tendon at its calcaneal insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteCanada
- Study dates
- 12 Aug 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Didem Bozak, 4163236008, didem.bozak@wchospital.ca
About this study
Official title: Single-Row Versus Double-Row Repair in the Surgical Management of Achilles Insertional Tendinopathy: A Randomized Controlled Trial (STRIDE 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.
Read the detailed description
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.
- Being tested
- Single-row repair of the Achilles tendon at its calcaneal insertion, Double-row repair of the Achilles tendon at its calcaneal insertion
- Keywords
- single row repair, double row repair, calcaneal insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-row repair of the Achilles tendon at its calcaneal insertionProcedure or surgery
single-row (2 anchors)
Double-row repair of the Achilles tendon at its calcaneal insertionProcedure or surgery
double-row (4 anchors)
| Study group | Role | What they receive |
|---|---|---|
| Single-row repair Arm | Active comparator | Single-row repair will involve 2 suture anchors (2 anchors total) Receives: 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) Receives: Procedure: Double-row repair of the Achilles tendon at its calcaneal insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after surgery
Secondary outcomes (8)
Surgical Cost
Assess the cost difference between single-row repair versus double-row repair
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months after surgery
Surgical Time
Assess the operative time required for single-row repair versus double-row repair.
Measured: 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.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start12 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Insertional TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective randomized controlled clinical trial of patients undergoing surgical management for chronic Achilles insertional tendinopathy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, University Health Network, Toronto, Unity Health Toronto, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Si-Hyeong Sam Park, MD, FRCPC, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323875
- Sponsor's protocol ID
- CTO-5686
- Acronym
- STRIDE
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Row Versus Double-Row Repair in the Surgical Management of Achilles Insertional Tendinopathy: A Randomized Controlled Trial (STRIDE Trial)
- ClinicalTrials.gov ID
- NCT07323875
- Acronym / sponsor ID
- STRIDE / CTO-5686
- Keywords
- single row repair, double row repair, calcaneal insertion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, University Health Network, Toronto, Unity Health Toronto, University of Toronto
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective randomized controlled clinical trial of patients undergoing surgical management for chronic Achilles insertional tendinopathy.
| Arm | Type | Receives |
|---|---|---|
| Single-row repair Arm | Active comparator | Procedure: Single-row repair of the Achilles tendon at its calcaneal insertionSingle-row repair will involve 2 suture anchors (2 anchors total) |
| Double-row repair Arm | Active comparator | Procedure: Double-row repair of the Achilles tendon at its calcaneal insertionDouble-row repair will involve 2 suture anchors for the proximal row and 2 suture anchors for the distal row (4 anchors total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-row repair of the Achilles tendon at its calcaneal insertionsingle-row (2 anchors) | Procedure or surgery | Single-row repair Arm |
| Double-row repair of the Achilles tendon at its calcaneal insertiondouble-row (4 anchors) | Procedure or surgery | Double-row repair Arm |
Primary outcome
Disease-specific outcomes
Time frame: 24 months after surgery
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.
8 secondary outcomes
Surgical Cost
Time frame: Within 2 hours of surgery
Foot and Ankle Ability Measure (FAAM)
Time frame: 24 months after surgery
Visual Analogue Scale Foot and ankle (VAS-FA)
Time frame: 24 months after surgery
Plantarflexion strength
Time frame: 24 months after surgery
Biomechanical performance
Time frame: 24 months after surgery
Functional endurance
Time frame: 24 months after surgery
Surgical Time
Time frame: During surgery
TENDINopathy Severity Assessment - Achilles (TENDINS-A)
Time frame: 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Achilles Insertional Tendinopathy
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Tendinopathy, Insertional Achilles Tendinopathy
Active, not recruiting
Augmenting Standard Rehabilitation With Blood Flow Restriction for Chronic Achilles Tendinopathy
Achilles Tendinopathy (AT)
Not yet recruiting
Achilles Tendinopathy; the Effect of Shockwave Treatment
Achilles Tendinopathy (AT), Achilles Tendon
Enrolling by invitation
Dry Needling and Exercise for Mid-portion Achilles Tendinopathy
Non-Insertional Achilles Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Si-Hyeong Sam Park, MD, FRCPC principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-row repair of the Achilles tendon at its calcaneal insertion and Double-row repair of the Achilles tendon at its calcaneal insertion in people with Achilles Insertional Tendinopathy and Achilles Tendinopathy, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Didem Bozak (6473814051, didem.bozak@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-specific outcomes (time frame: 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.