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

November 7, 2022 updated by: Katarina Nilsson Helander, Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västra Götalandsregionen
      • Göteborg, Västra Götalandsregionen, Sweden
        • Department of orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Katarina Nilsson Helander, MD PhD, Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

May 17, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATR ultrasound study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rupture

Clinical Trials on Surgical treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe