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

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04420832
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Rupture; Athletic Injuries; Ultrasonography; Rupture; Acute Disease	Procedure: Surgical treatment; Other: Non-surgical treatment	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Difference in functional outcome between patients treated surgically and non-surgically [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 [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 [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 [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) [6 months]

   Achilles tendon length - measured using US extended field of view

2. Ultrasonography (US) [12 months]

   Achilles tendon length - measured using US extended field of view

3. Ultrasonography (US) [24 months]

   Achilles tendon length - measured using US extended field of view

4. Achilles Tendon Rupture Score (ATRS) [3 months]

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

5. Achilles Tendon Rupture Score (ATRS) [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) [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) [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) [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) [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) [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) [24 months]

    PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthopedics	Göteborg	Västra Götalandsregionen	Sweden

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katarina Nilsson Helander, Principal investigator, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT04420832
• Other Study ID Numbers: ATR ultrasound study
• First Posted: Jun 9, 2020
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Disease; Rupture; Athletic Injuries

Study Results

No Results Posted as of Oct 22, 2020