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Achilles Tendon RuptureNCT03525314

Development of Achilles Tendon Elongation and Its Effect on Physical Function the First Year After Rupture

An observational study of Achilles Tendon Rupture, run by Hvidovre University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to examine how elongation of the Achilles tendon develops during the first year after rupture among patients with an Achilles tendon rupture, and how it affects physical function. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Achilles Tendon Rupture
How many people
67 participants
Where
1 siteDenmark
Study dates
6 Jun 2018to 10 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Adult, Older adult

Study population: All patients treated for acute Achilles tendon rupture at Amager-Hvidovre Hospital during the study period will be offered to participate in the study. The study cohort of study with uniqe clinical trials ID: Achilles HVH RCT is also included in this cohort.

Who may be able to join

  • 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 postexaminations.
  • The patient must be able to speak and understand Danish.
  • The patient must be able to give informed consent.

Who cannot join

  • 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 Fluorquinolons 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.
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Physiotherapy and Orthopedical surgery, Copenhagen University Hospital, Amager-Hvidovre

    Copenhagen, Hvidovre, DK-2650

Other trials in Denmark

About this study

Official title: Development of Achilles Tendon Elongation and Its Effect on Physical Function the First Year After Rupture: A Prospective Cohort Study

The objective of this study is to examine how elongation of the Achilles tendon develops during the first year after rupture among patients with an Achilles tendon rupture, and how it affects physical function.

The aim is to define a cutoff of acceptable elongation dividing the patients who obtain normal physical function (Limb Symmetry Index > 90%) from those who do not.

Patients treated both operatively and non-operatively will be included.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Copenhagen Achilles 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 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. The total length of the achilles tendon is the distance between the proximal border of calcaneus and the musculotendinous junction of the medial gastrocnemius muscle. Measurement is perfomed as described by Barfod et al (1).

    Measured: Evaluation method after 12 months of started treatment

Secondary outcomes (6)

  1. Copenhagen Achilles 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 free part is measured from week 9). 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. The total length of the achilles tendon is the distance between the proximal border of calcaneus and the musculotendinous junction of the medial gastrocnemius muscle. Measurement is perfomed as described by Barfod et al (1).

    Measured: Evaluation method after 0-4 days, 3 weeks, 9 weeks, 4 months, 6 months of started treatment

  2. 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.

    Measured: Evaluation method after 9 weeks, 4, 6 and 12 months of started treatment.

  3. 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.

    Measured: Evaluation method after 0-4 days, 3 weeks, 9 weeks, 4, 6 and 12 months of started treatment

  4. 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.

    Measured: Evaluation method after 4, 6 and 12 months of started treatment.

  5. Calf circumference

    The patient is sits on an examination bed with legs hanging down. The circumference of the calf is measured using a measuring tape (13 cm under apex patella).

    Measured: Evaluation method after 9 weeks, 4, 6 and 12 months of started treatment

  6. MRI

    MRI will be conducted to obtain a deeper understanding of how the different structures in the muscle-tendon complex change the first year after rupture. The MRI will be conducted at Copenhagen University Hospital Amager-Hvidovre in an Acanto 1,5 T scanner. Both lower legs will be scanned. The patient's head and upper-body are outside the scanner. Total time for the patient in the scanner is approximately 20 minutes.

    Measured: After 1 year of the started treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start6 Jun 2018
  3. Primary completion10 Dec 2020
  4. Study completion10 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525314
Sponsor's protocol ID
Achilles HVH Cohort
Status last verified
Mar 2022
First submitted
3 May 2018
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan of sharing data with researchers not already included in this study.

Publications

  • 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.

    PubMed 25038882

Questions about this trial

What is this clinical trial studying?

An observational study of Achilles Tendon Rupture, run by Hvidovre University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Copenhagen Achilles Length Measure (time frame: Evaluation method after 12 months of started treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03525314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

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