Cerebral PalsyNCT06875011
Percutaneous Needle Technique is Comparable to Open Z-plasty Surgery for Unilateral Tendon Achilles Lengthening in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Equinus Foot Deformity in Children With Cerebral Palsy, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Equinus Foot Deformity in Children With Cerebral Palsy, Gait Analysis in Neurological Disorders
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Palsy, Equinus Foot Deformity in Children With Cerebral Palsy, Gait Analysis in Neurological Disorders
- Keywords
- cerebral palsy, tendon Achilles, open surgery, z-plasty lengthening, needle lengthening technique
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Passive Ankle Dorsiflexion (Degrees)
Passive Ankle Dorsiflexion (Degrees) measured with the knee flexed.
Measured: Measured with the knee extended at one year postoperatively.
Secondary outcomes (4)
Active Ankle Dorsiflexion (Degrees)
Active Ankle Dorsiflexion (Degrees): Measured with the knee extended and flexed.
Measured: Measured with the knee extended at one year postoperatively.
Maximum Ankle Dorsiflexion in Stance Phase
Maximum Ankle Dorsiflexion in Stance Phase: Kinematic analysis during 3D gait analysis.
Measured: Measured with the knee extended at one year postoperatively.
Propulsive Power in Terminal Stance
Propulsive Power in Terminal Stance: Measured in watts per kilogram using kinetic analysis.
Measured: Measured with the knee extended at one year postoperatively.
Postoperative Complications
Postoperative Complications: Incidence of infections, hematoma, and re-ruptures within the first postoperative year.
Measured: Measured with the knee extended at one year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Jan 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875011
- Sponsor's protocol ID
- 1000168
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Needle Technique is Comparable to Open Z-plasty Surgery for Unilateral Tendon Achilles Lengthening in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06875011
- Acronym / sponsor ID
- 1000168
- Conditions
- Cerebral Palsy, Equinus Foot Deformity in Children With Cerebral Palsy, Gait Analysis in Neurological Disorders
- Keywords
- cerebral palsy, tendon Achilles, open surgery, z-plasty lengthening, needle lengthening technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Passive Ankle Dorsiflexion (Degrees)
Time frame: Measured with the knee extended at one year postoperatively.
Passive Ankle Dorsiflexion (Degrees) measured with the knee flexed.
4 secondary outcomes
Active Ankle Dorsiflexion (Degrees)
Time frame: 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.
Propulsive Power in Terminal Stance
Time frame: Measured with the knee extended at one year postoperatively.
Postoperative Complications
Time frame: Measured with the knee extended at one year postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Equinus Foot Deformity in Children With Cerebral Palsy, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive Ankle Dorsiflexion (Degrees) (time frame: Measured with the knee extended at one year postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.