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OpenTrials
Completed

NCT Number: NCT06875011

Percutaneous Needle Technique is Comparable to Open Z-plasty Surgery for Unilateral Tendon Achilles Lengthening in Children With Cerebral Palsy

This study aims to compare the outcomes of two surgical techniques for Achilles tendon lengthening in ambulatory children with cerebral palsy (CP): the percutaneous needle technique and the traditional open Z-lengthening technique. The primary objective is to evaluate the effectiveness of these techniques in improving ankle dorsiflexion and gait function one year postoperatively. Secondary objectives include assessing postoperative complications, re-rupture rates, and patient satisfaction. The study is designed as a retrospective, matched-pair cohort study, utilizing data from clinical records, 3D gait analysis (3DGA), and structured telephone interviews.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestreviken

Drammen, Buskerud, 3004, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ambulatory children with spastic cerebral palsy (unilateral or bilateral).
  • Indication for Achilles tendon lengthening confirmed by 3D gait analysis.
  • Underwent unilateral either percutaneous needle technique or open Z-lengthening between 2015 and 2022.
  • Availability of preoperative and one-year postoperative 3D gait analysis data.
  • Informed consent obtained.

Exclusion criteria

  • Multilevel surgical interventions.
  • Previous foot surgeries that alter foot anatomy.
  • Non-compliance with rehabilitation protocols or orthotic use.
  • Botulinum toxin-A injections in the triceps surae within six months pre- or post-surgery.
  • Incomplete or inadequate 3D gait analysis data.
  • Lack of informed consent.

Treatment and study plan

Primary outcomes

  1. Passive Ankle Dorsiflexion (Degrees)

    Time frame: Measured with the knee extended at one year postoperatively.

    Passive Ankle Dorsiflexion (Degrees) measured with the knee flexed.

Secondary outcomes

  1. Active Ankle Dorsiflexion (Degrees)

    Time frame: Measured with the knee extended at one year postoperatively.

    Active Ankle Dorsiflexion (Degrees): Measured with the knee extended and flexed.

  2. Maximum Ankle Dorsiflexion in Stance Phase

    Time frame: Measured with the knee extended at one year postoperatively.

    Maximum Ankle Dorsiflexion in Stance Phase: Kinematic analysis during 3D gait analysis.

  3. Propulsive Power in Terminal Stance

    Time frame: Measured with the knee extended at one year postoperatively.

    Propulsive Power in Terminal Stance: Measured in watts per kilogram using kinetic analysis.

  4. Postoperative Complications

    Time frame: Measured with the knee extended at one year postoperatively.

    Postoperative Complications: Incidence of infections, hematoma, and re-ruptures within the first postoperative year.

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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