NCT07090057

Brief Summary

Tight ankle muscles can produce ankle equinus (limited ability to pull the foot upward) and occur often in children, significantly impacting their ability to walk. If not treated, children with ankle equinus frequently experience reduced function and long-term foot problems, such as pain. Currently, treatment options include surgery or Botulinum toxin (BoNTA) injection into the large calf muscles that point the foot downwards, aiming to reduce their tightness. However, these treatments can be less effective over time, can create prolonged calf weakness, and may require long-term bracing. Another small muscle in the leg, the plantaris, is believed to have some contribution to equinus in many children. It is sometimes included in treatment plans for equinus but its contribution is poorly understood. It is unclear whether targeting the plantaris alone could lead to better treatment of ankle equinus. Understanding the effect of treatments targeting the plantaris could help clinicians improve the management of ankle equinus. In this study, the investigators will look at the impact of surgical treatment to the plantaris in ankle equinus. The investigators hypothesize that the plantaris is a significant contributor to equinus. In this study, data will be collected from children undergoing surgical correction of ankle equinus, including lengthening of the plantaris and lengthening of the larger muscles producing equinus (the gastrocsoleus mechanism). Children will be randomly assigned to have either their plantaris or the gastrocsoleus lengthening be done first during surgery. All children will have both structures lengthened during surgery, only the order will be varied and all surgical procedures for each patient will be completed in a single setting. In both groups, maximum passive ankle dorsiflexion (upwards bend of the ankle with the knee straight) will be measured before and after each structure is lengthened. The outcome is maximum passive ankle dorsiflexion (upwards bend of the ankle) with the knee straight. The investigators expect that maximum passive ankle dorsiflexion will increase after lengthening of the plantaris. Understanding the contribution of the plantaris muscle in ankle equinus could lead to significant improvements in the treatment of children with tight ankles.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Mar 2023Dec 2026

Study Start

First participant enrolled

March 13, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

July 22, 2025

Last Update Submit

March 11, 2026

Conditions

Keywords

tendoachilles lengtheninggastrocnemius recessionPlantaris lengthening

Outcome Measures

Primary Outcomes (4)

  • Maximum passive ankle dorsiflexion

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

    Prior to skin incision

  • Maximum passive ankle dorsiflexion

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

    Prior to division of first tendon/aponeurosis

  • Maximum passive ankle dorsiflexion

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

    After division of first tendon/aponeurosis

  • Maximum passive ankle dorsiflexion

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

    After division of second tendon/aponeurosis

Study Arms (2)

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

EXPERIMENTAL

Participants undergo Tendoachilles (TA) lengthening or gastrocnemius (GN) recession surgery before Plantaris tenotomy.

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

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

EXPERIMENTAL

Participants undergo Plantaris tenotomy surgery before Tendoachilles (TA) lengthening or gastrocnemius (GN) recession.

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

Interventions

Participants undergo Tendoachilles (TA) lengthening or gastrocnemius (GN) recession surgery before Plantaris tenotomy.

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

Participants undergo plantaris tenotomy surgery before Tendoachilles (TA) lengthening or gastrocnemius (GN) recession.

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

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Passive plantarflexion on affected side greater than 20° and greater than degree of equinus contracture.
  • Note: may be isolated or in conjunction with other orthopaedic procedures; in bilateral ankle equinus procedures, data will be collected bilaterally, but included as a single participant (i.e., single randomization).

You may not qualify if:

  • Unable to provide informed consent/assent in English.
  • Previous surgery for equinus
  • Limb deficiency on affected side
  • Knee flexion contracture of greater than 5°
  • Surgical intervention of the lower extremities below the affected knee in the last twelve months
  • BoNTA injections below the affected knee within the last six months
  • Known or suspected arthrofibrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G2B7, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral PalsySpastic Paraplegia, HereditaryBrain Injuries, TraumaticSpinal Cord InjuriesStrokeCharcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHereditary Sensory and Motor NeuropathyNervous System MalformationsHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSpinal Cord DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Sukhdeep Dulai, MD, MHSc, FRCSC

    University of Alberta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Collaborative Orthopaedic Research (CORe)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Data will be collected from 42 children undergoing surgical intervention for ankle equinus. Subjects will be randomly allocated into two groups of equal size: 1) plantaris lengthened before the lengthening of gastrocsoleus and 2) plantaris lengthened after gastrocsoleus lengthening. All surgical procedures for each patient will be completed in a single setting.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2025

First Posted

July 29, 2025

Study Start

March 13, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations