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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Drammen Sykehus, Vestre Viken HF
RECRUITING
Drammen
Contact Information
Primary
Per Reidar Høiness, MD Phd
prhoines@vestreviken.no
+47 975 27 911
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 50
Treatments
Active_comparator: Tendon Achilles Lengthening using needle technique
The arm in question involves the administration of a specific intervention via a precise needle technique, as outlined in the study protocol. The needle technique employed ensures optimal delivery of the intervention, ensuring safety and efficacy for the patient population under investigation. Further details regarding the needle technique are described in the full protocol.
Related Therapeutic Areas
Sponsors
Leads: Vestre Viken Hospital Trust

This content was sourced from clinicaltrials.gov