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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420832
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears 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

  6. Achilles Tendon Rupture Score (ATRS) [ Time Frame: 12 months ]
    Patient reported outcome measure (PROM) specific for achilles tendon rupture

  7. Achilles Tendon Rupture Score (ATRS) [ Time Frame: 24 months ]
    Patient reported outcome measure (PROM) specific for achilles tendon rupture

  8. Physical Activity Scale (PAS) [ Time Frame: 3 months ]
    PROM to measure overall physical activity

  9. Physical Activity Scale (PAS) [ Time Frame: 6 months ]
    PROM to measure overall physical activity

  10. Physical Activity Scale (PAS) [ Time Frame: 12 months ]
    PROM to measure overall physical activity

  11. Physical Activity Scale (PAS) [ Time Frame: 24 months ]
    PROM to measure overall physical activity



Information from the National Library of Medicine

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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
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Responsible Party: Katarina Nilsson Helander, MD PhD, 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: June 9, 2020
Last Verified: June 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