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Plantaris Sx

Targeting Plantaris Muscle-tendon Unit in Ankle Equinus Surgical Correction for Children

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Study AimThis study examines the impact of targeting the Plantaris muscle-tendon unit in surgical correction of ankle equinus in children, measuring ankle dorsiflexion during surgery.
What is being tested

Tendoachilles (TA) lengthening or gastrocnemius (GN) recession, then Plantaris tenotomy

+ Plantaris tenotomy, then Tendoachilles (TA) lengthening or gastrocnemius (GN) recession
Procedure
Who is being recruted

Idiopathic Toe Walking
+5

+ Cerebral Palsy
+ Hereditary Spastic Paraparesis
From 4 to 17 Years
+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: March 2023

See protocol details

Summary

Principal SponsorUniversity of Alberta
Study ContactAilar Ramadi, PhD
Last updated: July 29, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: March 13, 2023Actual date on which the first participant was enrolled.

This study focuses on children who have a walking condition known as equinus gait, where the ability to flex the ankle upwards is reduced, often leading to walking on the toes. This condition can be linked to various causes such as cerebral palsy or idiopathic toe-walking. The study aims to explore how the plantaris muscle might be contributing to this issue. By understanding this, the study hopes to improve surgical methods used to correct ankle equinus, potentially allowing for less invasive surgeries and faster recovery times for children affected by this condition. In the study, children undergoing surgery for equinus contracture at the Stollery Children's Hospital will be randomly assigned to one of two groups. One group will have the plantaris tendon addressed before other muscle lengthening procedures, while the second group will have it addressed after. Surgeons will measure the range of motion in the ankle at different stages during the surgery to evaluate the impact of the plantaris tendon on ankle movement. This careful measurement aims to determine if addressing the plantaris muscle first can improve surgical outcomes and reduce the need for more extensive procedures, making recovery easier for young patients.

Official TitleThe Effect of Targeting the Plantaris Muscle-tendon Unit in Surgical Correction of Ankle Equinus in Children 
Principal SponsorUniversity of Alberta
Study ContactAilar Ramadi, PhD
Last updated: July 29, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
42 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 4 to 17 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Idiopathic Toe Walking
Cerebral Palsy
Hereditary Spastic Paraparesis
Traumatic Brain Injury
Spinal Cord Injury
Spinal Cord Tethering
Stroke
Hereditary Sensory-motor Neuropathy
Criteria
5 inclusion criteria required to participate
Ability to provided informed consent/assent in English.
Pediatric patients (4-17 years) who have consented for surgery for the management of equinus contracture \* (either TA lengthening or GN recession) at the Stollery Children's Hospital
Known underlying diagnosis of any of the following: idiopathic toe walking, cerebral palsy, hereditary spastic paraparesis, traumatic brain injury, spinal cord injury/tethering, hereditary sensory-motor neuropathy, stroke
Ability to maintain hindfoot and midfoot neutral during assessment

Show More Criteria

7 exclusion criteria prevent from participating
Surgical intervention of the lower extremities below the affected knee in the last twelve months
Known or suspected arthrofibrosis.
BoNTA injections below the affected knee within the last six months
Unable to provide informed consent/assent in English.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants undergo Tendoachilles (TA) lengthening or gastrocnemius (GN) recession surgery before Plantaris tenotomy.
Group II
Experimental
Participants undergo Plantaris tenotomy surgery before Tendoachilles (TA) lengthening or gastrocnemius (GN) recession.
Study Objectives
Primary Objectives

Ankle dorsiflexion (unit: degree) will be measured by the surgeon with a sterile goniometer during the surgery.

Ankle dorsiflexion (unit: degree) will be measured by the surgeon with a sterile goniometer during the surgery.

Ankle dorsiflexion (unit: degree) will be measured by the surgeon with a sterile goniometer during the surgery.

Ankle dorsiflexion (unit: degree) will be measured by the surgeon with a sterile goniometer during the surgery.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Stollery Children's HospitalEdmonton, CanadaSee the location
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One Study Center