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

Primary Purpose

Achilles Tendon Rupture, Athletic Injuries, Ultrasonography

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Surgical treatment
Non-surgical treatment
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Orthopedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Surgical treatment

Non-surgical treatment

Arm Description

Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy

Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy

Outcomes

Primary Outcome Measures

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.
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
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
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

Secondary Outcome Measures

Ultrasonography (US)
Achilles tendon length - measured using US extended field of view
Ultrasonography (US)
Achilles tendon length - measured using US extended field of view
Ultrasonography (US)
Achilles tendon length - measured using US extended field of view
Achilles Tendon Rupture Score (ATRS)
Patient reported outcome measure (PROM) specific for achilles tendon rupture
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.
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.
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.
Physical Activity Scale (PAS)
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Physical Activity Scale (PAS)
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Physical Activity Scale (PAS)
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Physical Activity Scale (PAS)
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.

Full Information

First Posted
May 17, 2020
Last Updated
November 7, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04420832
Brief Title
Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings
Acronym
DUSTAR
Official Title
Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture, Athletic Injuries, Ultrasonography, Rupture, Acute Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy
Arm Title
Non-surgical treatment
Arm Type
Other
Arm Description
Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Intervention Description
Se above
Intervention Type
Other
Intervention Name(s)
Non-surgical treatment
Intervention Description
See above
Primary Outcome Measure Information:
Title
Difference in functional outcome between patients treated surgically and non-surgically
Description
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.
Time Frame
3 months
Title
Difference in functional outcome between patients treated surgically and non-surgically
Description
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
Time Frame
6 months
Title
Difference in functional outcome between patients treated surgically and non-surgically
Description
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
Time Frame
12 months
Title
Difference in functional outcome between patients treated surgically and non-surgically
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Ultrasonography (US)
Description
Achilles tendon length - measured using US extended field of view
Time Frame
6 months
Title
Ultrasonography (US)
Description
Achilles tendon length - measured using US extended field of view
Time Frame
12 months
Title
Ultrasonography (US)
Description
Achilles tendon length - measured using US extended field of view
Time Frame
24 months
Title
Achilles Tendon Rupture Score (ATRS)
Description
Patient reported outcome measure (PROM) specific for achilles tendon rupture
Time Frame
3 months
Title
Achilles Tendon Rupture Score (ATRS)
Description
Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.
Time Frame
6 months
Title
Achilles Tendon Rupture Score (ATRS)
Description
Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.
Time Frame
12 months
Title
Achilles Tendon Rupture Score (ATRS)
Description
Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.
Time Frame
24 months
Title
Physical Activity Scale (PAS)
Description
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Time Frame
3 months
Title
Physical Activity Scale (PAS)
Description
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Time Frame
6 months
Title
Physical Activity Scale (PAS)
Description
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Time Frame
12 months
Title
Physical Activity Scale (PAS)
Description
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarina Nilsson Helander, MD PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedics
City
Göteborg
State/Province
Västra Götalandsregionen
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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