A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on … (NCT06912061) | Clinical Trial Compass
RecruitingNot Applicable
A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility
Norway50 participantsStarted 2025-01-01
Plain-language summary
For years, we have used a minimally invasive and biological variant of Achilles tendon lengthening using a needle inserted into the Achilles tendon so that it is weakened and can be gradually stretched to the desired length. So far, no negative effects, complications or tendon problems have been observed. A prospective study of a cohort of children and adolescents is planned where there is an indication for Achilles lengthening, such as spastic or non-spastic contracture and toe walking that results in an unwanted shortening of the Achilles tendon that makes walking difficult. We plan to include up to 50 children and adolescents over a two-year period and follow them closely for the first year after surgery. Pediatric physiotherapists will perform all clinical examinations to limit observer bias, and a radiologist will examine the tendon tissue with ultrasound before and one year after surgery to check anatomical conditions. The study will examine safety, effectiveness and feasibility of using the method, and anatomy, patient satisfaction and quality of life.
Who can participate
Age range
5 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 5-16 years
* Consent from parents/guardians
* Indication for Achilles tendon lengthening (toe walking, spasticity), both unilateral and bilateral:
* Equinus foot with dorsiflexion ≤ 0 degrees with the knee extended and the heel in neutral position.
* Symptomatic equinus foot, meaning a foot position causing pain, discomfort, increased fatigue, etc.
Exclusion Criteria:
* Unwillingness to participate, lack of consent
* Previous surgical Achilles tendon lengthening, e.g., for clubfoot
* Received BoNT-a injection in the triceps surae within the last 6 months
* Contracture in the ankle joint, i.e., equinus position not due to a tight Achilles tendon
* Positive Silfverskiöld test and dorsiflexion \> 5 degrees with the knee extended (indicating the need for gastrocnemius recession)
* Concurrent other surgery/other procedures on the same lower extremity, including BoNT-a injection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Passive ankle dorsiflexion (PDF)
Timeframe: Baseline, as measured preoperatively, then after 4 weeks, 6 months, and one year after the surgery.