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

NCT ID: NCT06875011

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy Equinus Foot Deformity in Children With Cerebral Palsy Gait Analysis in Neurological Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open z-TAL

Patients with CP who has undergone unilateral Tendon Achilles Lengthening by open z-plasty (open z-TAL)

No interventions assigned to this group

Needle PTAL

Patients with CP who has undergone unilateral Tendon Achilles Lengthening by percutaneous needle technique (needle PTAL)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vestreviken

Drammen, Buskerud, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1000168

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.