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NCT04420832 Clinical Trial

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

Ultrasonography Clinical Trial

— DUSTAR  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04420832
Other study ID # ATR ultrasound study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date August 2025

Study information
Verified date November 2022
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 128
Est. completion date August 2025
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical treatment
Se above
Other:
• Non-surgical treatment
See above

Locations
Country Name City State
Sweden Department of Orthopedics Göteborg Västra Götalandsregionen

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

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