Needle technique for lengthening Achilles tendon in children
A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility
This study is testing a new needle technique to help children with tight Achilles tendons walk better without needing major surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 5 Years to 16 Years |
| Sex | All |
| Sponsor | Vestre Viken Hospital Trust Academic / other |
| Locations | 1 site (Drammen) |
| Trial ID | NCT06912061 on ClinicalTrials.gov |
What this trial studies
This study evaluates a minimally invasive needle technique for lengthening the Achilles tendon in pediatric patients with equinus contracture, including those with idiopathic toe walking. The approach involves creating microtenotomies in the tendon using a needle, allowing for gradual stretching without traditional surgical incisions. Up to 50 children aged 5-16 will be included, and their progress will be monitored for one year post-procedure through clinical examinations and ultrasound assessments. The study aims to assess the safety, efficacy, and feasibility of this novel technique compared to conventional methods.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-16 with indications for Achilles tendon lengthening due to toe walking or spasticity.
Not a fit: Patients who have previously undergone Achilles tendon lengthening surgery or have other ankle joint contractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could provide a safer and less invasive option for children with Achilles tendon shortening, improving their mobility and quality of life.
How similar studies have performed: While similar needle techniques have shown promise in other conditions, this specific approach for Achilles tendon lengthening is relatively novel and has limited prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Drammen
- Drammen Sykehus, Vestre Viken HF — Drammen, Norway (Recruiting)
Study contacts
- Study coordinator: Per Reidar Høiness, MD Phd
- Email: prhoines@vestreviken.no
- Phone: +47 975 27 911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.