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Evaluating a New Needle Technique for Achilles Tendon Lengthening in Children and Teens Aged 5 to 16 Years A Study on Safety, Effectiveness, and Recovery
Led by Vestre Viken Hospital Trust · Updated on 2025-04-13
50
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new needle technique for Achilles tendon lengthening in children and adolescents aged 5 to 16 years who have conditions like spastic or non-spastic contracture and toe walking leading to shortening of the Achilles tendon. This minimally invasive method uses needle pricks to weaken and gradually stretch the tendon, aiming to avoid complications seen with traditional open or scalpel surgeries. The study will assess the safety, effectiveness, and feasibility of this approach over a two-year period with up to 50 participants. The procedure involves applying multiple microtenotomies to the Achilles tendon using a 1.1-1.2 mm withdrawal needle under local anesthesia. The tendon is stretched to achieve about 10-15 degrees of dorsiflexion before finishing. After the short 3-4 minute surgery, a soft plaster boot cast is applied, allowing immediate full weight-bearing. The cast is removed after 4 weeks, followed by gentle activity for 4 weeks, then unrestricted activity. Ultrasound and clinical examinations are performed before and one year after surgery to monitor tendon anatomy and function. Participants will have clinical tests performed by pediatric physiotherapists, including measurements of ankle dorsiflexion and muscle strength, as well as assessments of spasticity and neurological function before surgery. Quality of life is measured using the PedsQL scale through self-reports and parent-proxy reports at baseline and one year post-surgery. Data will be collected at baseline, 4 weeks, 6 months, and 1 year after the procedure to evaluate outcomes and monitor for complications. The total follow-up period extends to one year after surgery.
CONDITIONS
Brief Title
A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility
Research Team
P
Per Reidar Høiness, MD Phd
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