NCT06912061 A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility
| NCT ID | NCT06912061 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vestre Viken Hospital Trust |
| Condition | Equinus Contracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-01-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06912061 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 16 Years, studying Equinus Contracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06912061 currently recruiting?
Yes, NCT06912061 is actively recruiting participants. Visit ClinicalTrials.gov or contact Vestre Viken Hospital Trust to inquire about joining.
Where is the NCT06912061 trial being conducted?
This trial is being conducted at Drammen, Norway.
Who is sponsoring the NCT06912061 clinical trial?
NCT06912061 is sponsored by Vestre Viken Hospital Trust. The trial plans to enroll 50 participants.