RecruitingNot ApplicableNCT06912061

A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility


Sponsor

Vestre Viken Hospital Trust

Enrollment

50 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a minimally invasive needle technique to lengthen the Achilles tendon in children who walk on their toes (toe walking) due to a tight Achilles tendon or spasticity. **You may be eligible if...** - Your child is between 5 and 16 years old - Your child walks on their toes and cannot bring the foot to a flat or neutral position (less than or equal to 0 degrees of upward foot flex) - Toe walking causes your child pain, discomfort, or increased tiredness - You (parent or guardian) provide consent **You may NOT be eligible if...** - Your child has had Achilles tendon surgery before (such as for clubfoot) - Your child received Botox injections in the calf muscles within the last 6 months - The ankle is stiff due to joint tightness, not a tight tendon - Your child needs a different type of leg surgery alongside this Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENeedle tendon lengthening technique

Percutaneous Achilles tendon lengthening with the needle technique is performed by applying a series of microtenotomies to the tendon using needle pricks while the tendon is stretched. A withdrawal needle with a diameter of 1.1-1.2 mm is used. The needle pricks gradually weaken the tendon and stretch it to the desired length without opening the skin or tendon sheath. As a rule, it is desirable to achieve approximately 10-15 degrees of dorsiflexion before concluding the lengthening. Local infiltration anesthesia is applied, followed by a simple bandage. The surgical procedure typically takes 3-4 minutes. Finally, a boot cast in soft plaster with the foot and ankle in neutral position is applied, and it can be fully weight-bearing immediately. The cast is removed at the clinic after 4 weeks. After cast removal, the child/adolescent should be allowed gentle activity - not sports - for another 4 weeks, thereafter unrestricted activity. Physical therapy may be utilized as needed, locally.


Locations(1)

Drammen Sykehus, Vestre Viken HF

Drammen, Norway

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NCT06912061