Individualized Treatment of Acute Achilles Tendon Rupture

NCT03525964 | Completed DMC

• 1 other identifier: Viborg NVK 1-10-72-428-17
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Achilles Tendon Rupture

Keywords

Individualized treatment; Functional outcome

Outcome Measures

Primary Outcomes (1)

• Heel-rise work test

  An endurance test where the patient stands on one leg and lifts the heel up and down until exhaustion. The number and the height of the heel rises are counted and measured and plotted into a diagram on an X-axis and Y-axis respectively. The results are then compared to the weight of the patient and the total work is estimated as area under the curve. The heel lift distance between the heel and the floor is measured in millimeters. The procedure is performed on the uninjured leg first and subsequently on the injured leg. The patient is barefoot for the heel-rise work test and stands on a flat surface with a 10 degree inclination. For these functional tests a measurement system MuscleLab (Ergotest Technology, Oslo, Norway) will be used at all the centers.

  Evaluation method after 12 months of started treatment

Secondary Outcomes (5)

• Barfod's ultrasonographic length measure

  Evaluation method after 6 and 12 months of started treatment

• Indirectly, clinical Achilles tendon length estimate

  Evaluation method after 6 and 12 months of started treatment

• Complications

  Evaluation method after 12 months of started treatment

• Achilles tendon Total Rupture Score (ATRS)

  Evaluation method after 6 and 12 months of started treatment

• Heel-rise Work test

  Evaluation method after 6 months of started treatment

Study Arms (3)

Individualized treatment

EXPERIMENTAL

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.

Procedure: Individualized treatment of Acute Achilles tendon rupture.

Control group 1

ACTIVE COMPARATOR

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.

Procedure: Non-operative treatment

Control group 2

ACTIVE COMPARATOR

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.

Procedure: Operative treatment

Interventions

Individualized treatment of Acute Achilles tendon rupture. PROCEDURE

The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the Achilles tendon and the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon and consist of the free tendon and the fascia \[1\]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively. The cut-off at 7% elongation is determined for 75% sensitivity and 65% specificity of elongation.

Individualized treatment

Non-operative treatment PROCEDURE

Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

Control group 1

Operative treatment PROCEDURE

Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

Control group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead
• The Danish Rheumatism Association: collaborator

Study Sites (4)

Copenhagen University Hospital, Hvidovre

Hvidovre, DK-2650, Denmark

Location

Hospital Lillte Belt, Kolding

Kolding, DK-6000, Denmark

Location

Zealand University Hospital, Køge

Køge, DK-4600, Denmark

Location

Jutland Central Regional Hospital

Viborg, DK-8800, Denmark

Location

Related Publications (2)

• Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Dossing S, Troelsen A. Validation of a novel ultrasound measurement of achilles tendon length. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3398-406. doi: 10.1007/s00167-014-3175-2. Epub 2014 Jul 20.

  PMID: 25038882 BACKGROUND

• Hansen MS, Vestermark MT, Holmich P, Kristensen MT, Barfod KW. Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial. Trials. 2020 May 12;21(1):399. doi: 10.1186/s13063-020-04332-z.

  PMID: 32398120 DERIVED

Study Officials

• Marianne T Vestermark, MD PhD

  Central Jutland Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The posterior site of the achilles tendon region is covered by dark tape during the functional assesments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Orthopaedic Resaerch, MD PhD

Model Details: Prospective

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: May 16, 2018
• Study Start: October 2, 2018
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)