Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings

Study Overview
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Brief Summary
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Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the distance between the ends of the tendon the investigators will decide if the patient is going to be treated with or without surgery.

Official Title
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Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture

Conditions
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Achilles Tendon Rupture, Athletic Injuries, Ultrasonography, Rupture, Acute Disease

Intervention / Treatment
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* Procedure: Surgical treatment
* Other: Non-surgical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute achilles tendon rupture diagnosed less than 48 hours from injury mid-substance rupture Exclusion Criteria: previous achilles tendon rupture lower leg disability diabetes mellitus neurovascular disease immunosuppression non-Swedish speaker

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical treatment<br>Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy | Procedure: Surgical treatment<br>* Se above<br>|
| Other: Non-surgical treatment<br>Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy | Other: Non-surgical treatment<br>* See above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in functional outcome between patients treated surgically and non-surgically | The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated test which combines both the height of each heel-rise and the number of repetitions. | 3 months | 
| Difference in functional outcome between patients treated surgically and non-surgically | The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance | 6 months | 
| Difference in functional outcome between patients treated surgically and non-surgically | The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance | 12 months | 
| Difference in functional outcome between patients treated surgically and non-surgically | The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonography (US) | Achilles tendon length - measured using US extended field of view | 6 months | 
| Ultrasonography (US) | Achilles tendon length - measured using US extended field of view | 12 months | 
| Ultrasonography (US) | Achilles tendon length - measured using US extended field of view | 24 months | 
| Achilles Tendon Rupture Score (ATRS) | Patient reported outcome measure (PROM) specific for achilles tendon rupture | 3 months | 
| Achilles Tendon Rupture Score (ATRS) | Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome. | 6 months | 
| Achilles Tendon Rupture Score (ATRS) | Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome. | 12 months | 
| Achilles Tendon Rupture Score (ATRS) | Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome. | 24 months | 
| Physical Activity Scale (PAS) | PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome. | 3 months | 
| Physical Activity Scale (PAS) | PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome. | 6 months | 
| Physical Activity Scale (PAS) | PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome. | 12 months | 
| Physical Activity Scale (PAS) | PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome. | 24 months |