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Achilles Tendon RuptureNCT06602908

Functional Status for Surgically and Non-surgically Treated Patients With Acute Achilles Tendon Rupture Following a Public Municipal Rehabilitation

An observational study of Achilles Tendon Rupture, run by Københavns Kommune at 2 sites 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

A total Achilles tendon rupture is a common injury most often occuring in people aged between 30 and 50 years. The injury is more common amongst men than women (ratio 3:1) and typically occur during sports activities involving excentric and/or plyometric muscle work in plantar flexion of the foot (e.g., jumping… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Achilles Tendon Rupture
How many people
55 participants
Where
2 sitesDenmark
Study dates
15 Sep 2024to 30 Jun 2026
How long will I take part?
9 Months
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Surgically and non-surgically treated achilles tendon rupture referred to rehabilitation in the municipality of Copenhagen.

Who may be able to join

  • Patient has an acute achilles tendon rupture (treated within 14 days after injury).
  • Adult patients aged of 18 years or older.
  • Patients has given informed consent to participate in the study.

Who cannot join

  • Patients with bilateral achilles tendon rupture
  • Patients with re-rupture of previous achilles tendon rupture

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites
  • Centre of rehabilitation Nørrebro

    Copenhagen, 2200

  • Centre of rehabilitation Vanløse

    Vanløse, 2720

Other trials in Denmark

About this study

Official title: Functional Status for Surgically and Non-surgically Treated Patients With Acute Achilles Tendon Rupture Following a Public Municipal Rehabilitation - A Prospective Cohort Study

A total Achilles tendon rupture is a common injury most often occuring in people aged between 30 and 50 years. The injury is more common amongst men than women (ratio 3:1) and typically occur during sports activities involving excentric and/or plyometric muscle work in plantar flexion of the foot (e.g., jumping, sprinting, change of directions).

Overall, there is no significant difference in treatment outcomes between surgical and non-surgical treatment besides a slightly greater risk of adverse events in surgical treatment and a small increased risk of re-rupture in non-surgical treatment. Several studies have investigated the importance of rehabilitation protocols without outcome differences between groups comparing more or less aggressive strategies.

Read more

Achilles tendon rupture often leads to significant limitations in functional level. Some of the most common used outcome measures for functional status are the heel rise tests evaluating endurance and maximum heel rise height. Studies using these tests often shows substantial deficits several years after the injury.

The purpose of this study is to investigate factors associated with functional status after rehabilitation.

Keywords
Achilles Tendon Rupture, Cohort Study, Functional Status, Heel Rise Tests, Associating Factors, Public Municipal Rehabilitation

What participants receive

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

Study groups in NCT06602908
Study groupRoleWhat they receive
Surgically and non-surgically treated patients with achilles tendon ruptureOne hundred patients with surgically and non-surgically treated achilles tendon rupture referred to rehabilitation in the municipality of Copenhagen.

What is being measured

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

  1. Functional test battery: Heel rise test for endurance and maximal height

    Heel rise test for endurance:

    One legged heel rise test performed in standing position barefooted on the floor with fingertips placed against the wall for balance.

    Number of repetitions until failure is counted on non-injured leg and afterwards on injured leg. The difference between injured leg and non-injured leg is measured by

    Limb Symmetry Index in % (LSI):

    (injured leg)/(non-injured leg) x 100

    Heel rise test for maximal height:

    One legged heel rise test performed in standing position barefooted on the floor with fingertips placed against the wall for balance.

    The patient is instructed to go as high as possible. The height from the floor until the distal end of calcaneus is measured with a tape measure to the nearest 0.1 cm.

    The difference between injured leg and healthy leg is measured by

    Limb Symmetry Index in % (LSI):

    (injured leg)/(non-injured leg) x 100

    Measured: LSI is measured at the final visit during rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

Secondary outcomes (8)
  1. Patient Specific Functional Score (PSFS)

    Patients are asked to identify 5 activities they are having difficulty with as a result of their current problem.

    Each activity is scored on a 0 (unable to perform activity) to 10 (able to perform activity at same level as before injury or problem) points numeric rating scale.

    An average Patient-Specific Functional Scale (PSFS) score is calculated and can vary from 0 to 10, with higher scores representing higher levels of lower extremity functional status.

    Measured: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

  2. Pain Numeric Rating Scale (NRS)

    The NRS is a modified version of the Visuel Analog Scale that consists of a segmented numerical scale with 11 points ranging from 0 to 10. The 11-point numeric scale ranges from 0 representing "no pain" to 10 representing the other pain extreme: "pain as bad as you can imagine" or "worst pain imaginable".

    This scale can be administered verbally or graphically.

    Measured: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation).

  3. Achilles tendon Total Rupture Score (ATRS)

    The Achilles tendon Total Rupture Score (ATRS) is a commonly used patient-reported outcome measure for patients with an acute Achilles tendon rupture.

    It consists of 10 questions concerning symptoms and physical activity, for which patients are asked to respond using an 11-point Likert scale (0-10). A patient scoring 0 implies major limitations/symptoms and 10 no limitations or symptoms. Answers from all 10 questions are added to a total score, with 100 being the maximum score

    Measured: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

  4. Thompsons test

    Thompsons test (also called Simmonds squeeze test or Simmonds-Thompson test) is used in lower limb examination to test for the rupture of the Achilles tendon. The patient lies face down with feet hanging off the edge of the bed. If the test is positive, there is no movement of the foot (normally plantarflexion) on squeezing the corresponding calf, signifying likely rupture of the Achilles tendon.

    Measured: Assessment at baseline and the final visit of rehabilitation (Often 6 months from injury or operation).

  5. Achilles Tendon Resting Angle test (ATRA)

    Achilles tendon resting angle (ATRA) has been suggested and used as a surrogate measure of tendon length.

    In this test, patients are positioned in prone with the knee flexed to 90 degrees, and the passive angle that the foot falls is measured using a goniometer.

    The ATRA is the angle between the long axis of the fibula and the line from the tip of the fibula to the head of the fifth metatarsal.

    Amount of tendon elongation is defined as the difference between injured and non-injured sides (positive values indicating greater tendon length on the injured side).

    Measured: Assessment of relative ATRA (difference between non-injured and injured leg) at baseline and the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

  6. Circumference of lower leg

    Calf muscle atrophy is assessed by measuring the circumference 13 cm. below the distal apex of the patellae with a tape measure. The circumference will be recorded to the nearest 0.1 cm. and measured on both injured and the non-injured leg.

    Measured: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation).

  7. The Danish 13-item Tampa Score for Kinesiophobia (TSK-13)

    The TSK is originally a 17-item self-report scale with a 4-point response scale ranging from "strongly disagree" to "strongly agree".

    Items 4, 8, 12, and 16 are reversed for scoring. A 13-item version of the scale (TSK-13) without the four reversed items has also been widely used.

    The original 17-item scale results in a total score ranging from 17 to 68 points with increasing values indicating a stronger degree of Kinesiophobia. Therefore the 13-item version results in a total score ranging from 13 to 52 points with increasing values indicating a stronger degree of Kinesiophobia.

    Measured: Assessment at baseline and the final visit of rehabilitation (Often 6 months from injury or operation).

  8. Tegner score

    The Tegner activity score is developed as a measure of activity level. The rating system scores a person\'s activity level between 0 and 10, where 0 is "sick leave or disability pension because of the specific problem" and 10 is "participation in competitive sports such as soccer at a national or international elite level."

    Measured: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.

Timeline

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

  1. First posted19 Sep 2024
  2. Study start15 Sep 2024
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

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
55 participants (actual)
Target duration
9 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06602908
Sponsor's protocol ID
F-24036357
Status last verified
Aug 2026
First submitted
7 Sep 2024
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Achilles Tendon Rupture, run by Københavns Kommune at 2 sites 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 3 inclusion and 2 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Functional test battery: Heel rise test for endurance and maximal height (time frame: LSI is measured at the final visit during rehabilitation (Often 6 months from injury or operation). Further assessment 12 months follow up from injury or operation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Aug 2026.

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