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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-16
SponsorVestre Viken Hospital Trust

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age: 5-16 years

Consent from parents/guardians

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Needle tendon lengthening technique

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Tendon Achilles Lengthening using needle techniqueActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Passive ankle dorsiflexion (PDF)

Passive ankle dorsiflexion (PDF) (degrees) lying down with an extended knee using a goniometer. The examination is performed by experienced physiotherapists that are not involved in the project.

Time frame
Baseline, as measured preoperatively, then after 4 weeks, 6 months, and one year after the surgery.

Secondary outcomes

1

Passive ankle dorsiflexion (PDF)

Passive ankle dorsiflexion (PDF) (degrees) with a bent knee using a goniometer. The examination is performed by experienced physiotherapists that are not involved in the project.

Time frame
Baseline, as measured preoperatively, then after 4 weeks, 6 months, and one year after surgery.
2

Active ankle dorsiflexion (ADF)

Active ankle dorsiflexion (ADF) (degrees) with a bent knee (goniometer). The examination is performed by experienced physiotherapists that are not involved in the project.

Time frame
Baseline, as measured preoperatively, then after 4 weeks, 6 months, and one year after the surgery.
3

Plantar flexion strength

Plantar flexion strength (Kg) as measured clinically and with a handheld dynamometer, performed by experienced physiotherapists that are not involved in the science project.

Time frame
Baseline, as measured preoperatively, then after 6 months, and one year after the surgery.
4

Complications and adverse events

All complications and adverse events, such as re-ruptures, wound infections, bleeding, and necrosis within the first postoperative year are noted.

Time frame
At follow-up check-ups after 4 weeks, 6 months, and one year after the surgery.

Other outcomes

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