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NCT Number: NCT04420832

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Achilles Tendon Rupture Acute Disease Athletic Injuries Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Rupture Ultrasonography Wounds and Injuries

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedics

Gothenburg, Västra Götalandsregionen, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical treatment

Procedure

Se above

Non-Surgical Treatment

Other

See above

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Ultrasonography (US)

    Time frame: 6 months

    Achilles tendon length - measured using US extended field of view

  2. Ultrasonography (US)

    Time frame: 12 months

    Achilles tendon length - measured using US extended field of view

  3. Ultrasonography (US)

    Time frame: 24 months

    Achilles tendon length - measured using US extended field of view

  4. Achilles Tendon Rupture Score (ATRS)

    Time frame: 3 months

    Patient reported outcome measure (PROM) specific for achilles tendon rupture

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Acronym: DUSTAR

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2020
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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