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

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ClinicalTrials.gov Identifier: NCT04420832
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Katarina Nilsson Helander, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Athletic Injuries Ultrasonography Rupture Acute Disease Procedure: Surgical treatment Other: Non-surgical treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420832


Contacts
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Contact: Katarina Nilsson Helander, MD PhD 0046703218420 katarina.nilsson.helander@vgregion.se

Locations
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Sweden
Department of Orthopedics Recruiting
Göteborg, Västra Götalandsregionen, Sweden
Contact: Katarina NIlsson Helander, MD PhD    000703218420    katarina.nilsson.helander@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Katarina Nilsson Helander, MD PhD Sahlgrenska University Hospital, Sweden
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Responsible Party: Katarina Nilsson Helander, Principal investigator, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04420832    
Other Study ID Numbers: ATR ultrasound study
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Disease
Rupture
Athletic Injuries
Wounds and Injuries
Disease Attributes
Pathologic Processes