- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875011
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
Status
Completed
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Brain Diseases
- Central Nervous System Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Brain Damage, Chronic
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Cerebral Palsy
- Nervous System Diseases
- Paralysis
- Foot Deformities
- Foot Deformities, Congenital
Other Study ID Numbers
- 1000168
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.
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