Individualized Treatment of Acute Achilles Tendon Rupture

Not Applicable

Completed

• Conditions: Achilles Tendon Rupture

• Registration Number: NCT03525964
• Lead Sponsor: Central Jutland Regional Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-16
• Study Start: 2018-10-02
• Primary Completion: 2024-09-24
• Study Completion: 2024-09-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heel-rise work test	Evaluation method after 12 months of started treatment	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.

Secondary Outcome Measures

Name	Time	Method
Barfod's ultrasonographic length measure	Evaluation method after 6 and 12 months of started treatment	The examination of both the total and the free part of the achilles tendon of both the injured and un-injured leg is performed. The total length of the tendon is defined under the description of the intervention. The free part of the achilles tendon is defined as the distance between the proximal border of calcaneus and the musculotendinous junction of the soleus muscle and the achilles tendon. The method will be used both diagnostically for the individualized treatment and as a secondary endpoint.
Complications	Evaluation method after 12 months of started treatment	Incidence rate of the commonly known complications and adverse events such as infection, re-rupture, permanent sural nerve dysfunction, adhesions and pain at the scar is noted. Attention is also paid to so far unknown complications in relation to the treatments.
Achilles tendon Total Rupture Score (ATRS)	Evaluation method after 6 and 12 months of started treatment	Patients will fill out the ATRS questionnaire in connection to the follow-up visits in the Outpatients Department. ATRS is a patient-reported outcome measure.; This questionnaire is a part of the usual examination of the patients' function, and is used during all follow-ups in the usual care.
Heel-rise Work test	Evaluation method after 6 months of started treatment	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.
Indirectly, clinical Achilles tendon length estimate	Evaluation method after 6 and 12 months of started treatment	Achilles tendon length is indirectly estimated clinically by use of the Achilles Tendon Resting Angle (ATRA) or the Achilles Tendon Length Measure (ATLM). The patient lies flat in prone position on the examination bed. The knee is flexed at 90 degrees and the ankle sits in relaxed position. The ATRA is determined as the angle between the corpus of the fibula and the corpus of the 5th metatarsus. The ATLM is determined as the distance from the caput of the 5th metatarsus to the surface of the examination bed. Both the ATRA and the ATLM are determined for both the injured and the uninjured leg. The difference between the healthy and the injured leg is evaluated

Trial Locations

Locations (4)

Copenhagen University Hospital, Hvidovre; 🇩🇰 Hvidovre, Denmark

Hospital Lillte Belt, Kolding; 🇩🇰 Kolding, Denmark

Zealand University Hospital, Køge; 🇩🇰 Køge, Denmark

Jutland Central Regional Hospital; 🇩🇰 Viborg, Denmark