Clinical trial NCT06602908: Functional Status for Surgically and Non-surgically Treated Patients With Acute Achilles Tendon Rupture Following a Public Municipal Rehabilitation
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achilles Tendon Rupture
Keywords: Achilles Tendon Rupture
Cohort Study
Functional Status
Heel Rise Tests
Associating Factors
Public Municipal Rehabilitation
Lead sponsor: Københavns Kommune
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgically and non-surgically treated achilles tendon rupture referred to rehabilitation in the municipality of Copenhagen.

Brief 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, 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Functional test battery: Heel rise test for endurance and maximal height
timeFrame: 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:
measure: Patient Specific Functional Score (PSFS)
timeFrame: 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.
measure: Pain Numeric Rating Scale (NRS)
timeFrame: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation).
measure: Achilles tendon Total Rupture Score (ATRS)
timeFrame: 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.
measure: Thompsons test
timeFrame: Assessment at baseline and the final visit of rehabilitation (Often 6 months from injury or operation).
measure: Achilles Tendon Resting Angle test (ATRA)
timeFrame: 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.
measure: Circumference of lower leg
timeFrame: Change from baseline to the final visit of rehabilitation (Often 6 months from injury or operation).
measure: The Danish 13-item Tampa Score for Kinesiophobia (TSK-13)
timeFrame: Assessment at baseline and the final visit of rehabilitation (Often 6 months from injury or operation).
measure: Tegner score
timeFrame: 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.
Other outcomes:
measure: Variables that may influence on outcome: Gender
timeFrame: Assessment at baseline
measure: Variables that may influence on outcome: Age
timeFrame: Assessment at baseline
measure: Variables that may influence on outcome: Smoking status
timeFrame: Assessed at baseline
measure: Variables that may influence on outcome: Body Mass Index (BMI)
timeFrame: Assessment at baseline
measure: Variables that may influence on outcome: Treatment status
timeFrame: Assessment after the final visit of rehabilitation (Often 6 months from injury or operation).
measure: Variables that may influenc on outcome: Length of rehabilitation period.
timeFrame: Assessment after the final visit of rehabilitation (Often 6 months from injury or operation).
measure: Variables that may influence on outcome: Number of supervised treatments in rehabilitation
timeFrame: Assessment after the final visit of rehabilitation (Often 6 months from injury or operation).
Locations:
city: Copenhagen N.
country: Denmark
facility: Centre of rehabilitation Nørrebro
city: Vanløse
country: Denmark
facility: Centre of rehabilitation Vanløse
Study officials:
References: