Individualized Treatment of Acute Achilles Tendon Rupture

Central Jutland Regional Hospital

Status: Completed

Conditions: Achilles Tendon Rupture

Treatments: Procedure: Operative treatment; Procedure: Individualized treatment of Acute Achilles tendon rupture.; Procedure: Non-operative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03525964

Viborg NVK 1-10-72-428-17

Details and patient eligibility

About

To asses the functional outcome after individualized treatment of acute achilles tendon rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon overlap and Barfod's Ultrasonographic length measure. Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.

The study includes two control groups of non-operative and operative treatment.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Appointment in the Outpatients Department within 4 days of injury.
• Total Achilles tendon rupture.
• Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
• The patient must be expected to be able to attend rehabilitation and post-examinations.
• The patient must be able to speak and understand Danish.
• The patient must be able to give informed consent.

Exclusion criteria

• Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
• Previous rupture of the Achilles tendon in any of the two legs.
• Treated with Fluoroquinolones or corticosteroids within the last 6 months.
• In medical treatment of diabetes.
• Suffers from rheumatic disease.
• Other conditions prior to the injury resulting in reduced function of any of the two legs.
• Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
• Inability to lie in prone position on the operating table.
• Terminal illness or severe medical illness: ASA (American Society of Anesthesiologists) score higher than or equal to 3.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Individualized treatment

Experimental group

Description:

The ruptured achilles tendon is examined by ultrasonography. If the overlap of the tendon ends is less than 25 % or the tendon is elongated 7 % or more the patient receives conventional open operative treatment. The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anaesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below-the-knee cast after surgery. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.

Treatment:

Procedure: Individualized treatment of Acute Achilles tendon rupture.

Control group 1

Active Comparator group

Description:

For the patients allocated to non-operative treatment the injured leg is placed in a circulated below-the-knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.

Treatment:

Procedure: Non-operative treatment

Control group 2

Active Comparator group

Description:

The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anaesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below-the-knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.

Treatment:

Procedure: Operative treatment