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Tendon InjuriesNCT02805751

Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures

A study testing Early loading on a training pedal, Tendon strain exercises and Early weight bearing in people with Tendon Injuries and Soft Tissue Injuries, run by Linkoeping University at 1 site in Sweden.

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 purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA). Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Early loading on a training pedal, Tendon strain exercises and Early weight bearing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSweden
Study dates
Oct 2015to Nov 2019
Phase
Interventional
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
  • Presented within 14 days from injury
  • 18-60 years old

Who cannot join

  • Inability to understand swedish
  • previous injured tendon
  • Diabetes mellitus
  • History of Rheumatoid disease
  • Treatment with steroids

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • University Hospital Linkoeping

    Linköping, Östergötland County, 58729

Other trials in Sweden

About this study

Official title: Mechanical Properties in Conservative Treated Achilles Tendon Ruptures With or Without Early Controlled Loading

The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA).

The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.

Read the detailed description

Treatment of Achilles tendon ruptures includes surgical repair or immobilization in an orthosis, followed by prolonged rehabilitation. Improved rehabilitation regimens still display imperfect recovery, with deficits such as persistent end-range muscle weakness, tendon elongation and incomplete return to pre-injury activity level. The underlying mechanisms are unknown, but are likely to involve molecular and cellular aspects of the early healing processes. Animal experiments have shown that short episodes of vigorous loading during tendon healing create a stronger tendon, and lead to less elongation than continuous loading. Early controlled training has also been shown to improve the material properties of surgically repaired tendons. However, more and more clinics now turn away from surgery and towards conservative treatment, while studies on rehabilitation mainly concern sutured tendons. It is therefore also important to understand how to best rehabilitate conservatively treated patients. The aim is to investigate the effect of early controlled loading on conservatively treated Achilles tendon ruptures.

The patients (age 18-60 years of age) are treated conservatively by receiving a removable foam walker boot at the emergency department. The patients are thereafter called by the principal investigator and are asked if they want to participate in the study. Patients who are interested in participating in the study receive oral and in written information about the study of the principal investigator of the study (Pernilla Eliasson).

After 2 weeks, the rupture is localized by ultrasound and 4 tantalum beads are implanted percutaneously in the proximal and distal part of the tendon. These beads are used for measurements of the mechanical properties of the tendon by using RSA.

The patients are thereafter randomized to early controlled loading or control.

All patients wear the foam walker boot for 7 weeks. Full weight-bearing is allowed as tolerated from the beginning. Both groups perform motion exercises outside the boot with 20 repetitions, 3 times per day as of 14 days after rupture.

The patients in the early loading group are provided with a special training pedal where pedal resistance can be increased during the treatment period. The patients will use this pedal twice a day starting 2 weeks after rupture.

After the initial 7 weeks, the patients are referred to physical therapists uninvolved in this research, but with the instruction to follow the regional rehabilitation guidelines for Achilles tendon ruptures.

Mechanical properties of the tendon will be estimated by measuring tendon length, cross-sectional area (CSA) and stiffness at week 7, 19 and 52.

The elastic modulus of the tendon at 19 weeks it the primary variable of this study.

At week 7, both the elastic and plastic deformation will be measured. Tendon CSA will be evaluated using computer tomography (CT). Tendon elongation will be evaluated by RSA at week 2, 7, 19 and 52. Calf muscle circumference, passive and active range of motion in the ankle joint and a heel-raise test will be performed at week 19 and 52.

The overall function will be assessed by the Achilles Tendon Rupture Score at 19 and 52 weeks.

Complications and re-ruptures will be registered.

Being tested
Early loading on a training pedal, Tendon strain exercises, Early weight bearing
Keywords
Achilles, Tendon, Loading, Rehabilitation
Medical subject headings
Tendon Injuries, Soft Tissue Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early loading on a training pedalDevice

    The patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal.

  • Tendon strain exercisesOther

    The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.

  • Early weight bearingOther

    The patients are allowed to bear weight as much as tolerated in the walker from day 1.

Study groups in NCT02805751
Study groupRoleWhat they receive
ControlActive comparatorThis constitutes the currently accepted regime and is therefore consider the control group (CTRL) with early range of motion and early weight bearing. The control group was allowed to have weight-bearing as tolerated from day 0. They are also instructed to perform tendon strain exercises 3 times each day from 2 weeks after the rupture.
Receives: Other: Tendon strain exercises; Other: Early weight bearing
Early loadingExperimentalThe patients in the early loading group are also allowed to have weight-bearing as tolerated from day 0 and perform tendon strain exercises 3 times each day from 2 weeks after the rupture. The patients in this group will also remove the walker twice a day and use a special training pedal for 5 weeks (until walker removal).
Receives: Device: Early loading on a training pedal; Other: Tendon strain exercises; Other: Early weight bearing

What is being measured

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

  1. Modulus of Elasticity

    Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.

    Measured: 19 weeks

Secondary outcomes (7)
  1. Tendon elongation

    Tendon elongation will be evaluated using RSA and measurements of the distance between tantalum beads

    Measured: 2, 7, 19 and 52 weeks after rupture

  2. Modulus of Elasticity

    Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.

    Measured: 7 and 52 weeks after rupture

  3. Achilles tendon total rupture score (ATRS)

    Patient reported outcome regarding function in their Achilles tendon

    Measured: 19 and 52 weeks after rupture

  4. Maximal range of motion

    The maximun range of motion in the ankle joint will be measured in plantar and dorsiflexion.

    Measured: 19 and 52 weeks after rupture

  5. Heel-rise

    The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.

    Measured: 19 and 52 weeks after rupture

  6. Plastic deformation of the tendon

    Plastic deformation will be measured using RSA and measurements of the distance between tantalum beads while the patient continues to have a load on the tendon for 3 minutes with a weight. Tendon size will be measured using CT.

    Measured: 7 weeks after rupture

  7. Calf muscle circumference

    Measurement of the circumference at the thickest part of the calf

    Measured: 19 and 52 weeks

Timeline

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

  1. First posted20 Jun 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionNov 2018
  4. Study completionNov 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02805751
Sponsor's protocol ID
Early loading
Status last verified
Jun 2016
First submitted
10 Jun 2016
Last updated
10 Aug 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rendek Z, Bon Beckman L, Schepull T, Danmark I, Aspenberg P, Schilcher J, Eliasson P. Early Tensile Loading in Nonsurgically Treated Achilles Tendon Ruptures Leads to a Larger Tendon Callus and a Lower Elastic Modulus: A Randomized Controlled Trial. Am J Sports Med. 2022 Oct;50(12):3286-3298. doi: 10.1177/03635465221117780. Epub 2022 Aug 25.

    PubMed 36005394

Questions about this trial

What is this clinical trial studying?

A study testing Early loading on a training pedal, Tendon strain exercises and Early weight bearing in people with Tendon Injuries and Soft Tissue Injuries, run by Linkoeping University at 1 site in Sweden.

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 3 inclusion and 5 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 10 Aug 2021. 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 Sweden. 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?

Modulus of Elasticity (time frame: 19 weeks). 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 NCT02805751, 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 10 Aug 2021.

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