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Individualized Treatment of Acute Achilles Tendon Rupture

Primary Purpose

Achilles Tendon Rupture

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Individualized treatment of Acute Achilles tendon rupture.

Non-operative treatment

Operative treatment

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Individualized treatment, Functional outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Copenhagen University Hospital, HvidovreRecruiting
Hospital Lillte Belt, KoldingRecruiting
Zealand University Hospital, Køge
Jutland Central Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Individualized treatment

Control group 1

Control group 2

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Barfod's ultrasonographic length measure

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.

Indirectly, clinical Achilles tendon length estimate

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

Complications

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)

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

Full Information

NCT ID

NCT03525964

First Posted

March 20, 2018

Last Updated

September 3, 2021

Sponsor

Central Jutland Regional Hospital

Collaborators

The Danish Rheumatism Association

1. Study Identification

Unique Protocol Identification Number

NCT03525964

Brief Title

Individualized Treatment of Acute Achilles Tendon Rupture

Official Title

Individualized Treatment for Acute Achilles Tendon Rupture Based on Barfod's Ultrasonographic Length Measure - a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 2, 2018 (Actual)

Primary Completion Date

May 14, 2024 (Anticipated)

Study Completion Date

November 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Jutland Regional Hospital

Collaborators

The Danish Rheumatism Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achilles Tendon Rupture

Keywords

Individualized treatment, Functional outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective

Masking

Outcomes Assessor

Masking Description

The posterior site of the achilles tendon region is covered by dark tape during the functional assesments.

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Individualized treatment

Arm Type

Experimental

Arm Description

Arm Title

Control group 1

Arm Type

Active Comparator

Arm Description

Arm Title

Control group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Individualized treatment of Acute Achilles tendon rupture.

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Non-operative treatment

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Operative treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Heel-rise work test

Description

Time Frame

Evaluation method after 12 months of started treatment

Secondary Outcome Measure Information:

Title

Barfod's ultrasonographic length measure

Description

Time Frame

Evaluation method after 6 and 12 months of started treatment

Title

Indirectly, clinical Achilles tendon length estimate

Description

Time Frame

Evaluation method after 6 and 12 months of started treatment

Title

Complications

Description

Time Frame

Evaluation method after 12 months of started treatment

Title

Achilles tendon Total Rupture Score (ATRS)

Description

Time Frame

Evaluation method after 6 and 12 months of started treatment

Title

Heel-rise Work test

Description

Time Frame

Evaluation method after 6 months of started treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marianne T Vestermark, MD PhD

Phone

+4578446692

marianne.vesterarmk@viborg.rm.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Edvard P Hvidt, MD

Phone

+4578446563

peter.hvidt@viborg.rm.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianne T Vestermark, MD PhD

Organizational Affiliation

Central Jutland Regional Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Copenhagen University Hospital, Hvidovre

City

Hvidovre

ZIP/Postal Code

DK-2650

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristoffer W Barfod, MD PhD

Phone

+4540134773

kbarfod@dadlnet.dk

First Name & Middle Initial & Last Name & Degree

Maria S Hansen, MSc

maria.swennergren.hansen@regionh.dk

Facility Name

Hospital Lillte Belt, Kolding

City

Kolding

ZIP/Postal Code

DK-6000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claus W Henriksen, MD

Phone

+4576 36 22 74

claus.w.henriksen@rsyd.dk

First Name & Middle Initial & Last Name & Degree

Stefan Møller, PT

Phone

+4576 36 22 74

stefan.moller@rsyd.dk

Facility Name

Zealand University Hospital, Køge

City

Køge

ZIP/Postal Code

DK-4600

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna K Pramming, MD

Phone

+4528117292

ankpr@regionsjaelland.dk

First Name & Middle Initial & Last Name & Degree

Louise L Simonsen, MD

Phone

+4560630666

llsm@regionsjaelland.dk

Facility Name

Jutland Central Regional Hospital

City

Viborg

ZIP/Postal Code

DK-8800

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marianne T Vestermark, MD PhD

Phone

+4578446692

marianne.vestermark@viborg.rm.dk

First Name & Middle Initial & Last Name & Degree

Edvard P Hvidt, MD

Phone

+4578446563

peter.hvidt@viborg.rm.dk

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan of sharing data with researchers not already included in this study.

Citations:

PubMed Identifier

25038882

Citation

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.

Results Reference

background

PubMed Identifier

32398120

Citation

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.

Results Reference

derived

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Individualized Treatment of Acute Achilles Tendon Rupture

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