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

March 28, 2025 updated by: Vestre Viken Hospital Trust
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.

Study Overview

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Buskerud
      • Drammen, Buskerud, Norway, 3004
        • Vestreviken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective, matched-pair cohort study investigates the outcomes of percutaneous needle technique versus open Z-lengthening for Achilles tendon lengthening in children with spastic cerebral palsy. The study will assess changes in ankle dorsiflexion, gait function, and the incidence of postoperative complications. Data will be gathered from 3D gait analysis reports, clinical records, and structured telephone interviews. The primary outcome is the degree of passive ankle dorsiflexion one year postoperatively. Secondary outcomes include active ankle dorsiflexion, adverse events and re-rupture rates. The results aim to inform clinical decision-making and optimize surgical management for children with CP-related gait impairments.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Open z-TAL
Patients with CP who has undergone unilateral Tendon Achilles Lengthening by open z-plasty (open z-TAL)
Needle PTAL
Patients with CP who has undergone unilateral Tendon Achilles Lengthening by percutaneous needle technique (needle PTAL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Passive Ankle Dorsiflexion (Degrees)
Time Frame: Measured with the knee extended at one year postoperatively.
Passive Ankle Dorsiflexion (Degrees) measured with the knee flexed.
Measured with the knee extended at one year postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured with the knee extended at one year postoperatively.
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.
Measured with the knee extended at one year postoperatively.
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.
Measured with the knee extended at one year postoperatively.
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.
Measured with the knee extended at one year postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Subscribe