Achilles Tendon RuptureDUSTARNCT04420832
Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings
A study testing Surgical treatment and Non-surgical treatment in people with Achilles Tendon Rupture and Athletic Injuries, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Achilles Tendon Rupture, Athletic Injuries, Ultrasonography
- What is being tested?
- Surgical treatment and Non-surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2020to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- acute achilles tendon rupture diagnosed less than 48 hours from injury
- mid-substance rupture
Who cannot join
- previous achilles tendon rupture
- lower leg disability
- diabetes mellitus
- neurovascular disease
- immunosuppression
- non-Swedish speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture
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.
- Being tested
- Surgical treatment, Non-surgical treatment
- Medical subject headings
- Athletic Injuries, Rupture, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatmentProcedure or surgery
Se above
Non-surgical treatmentOther
See above
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Active comparator | Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy Receives: Procedure: Surgical treatment |
| Non-surgical treatment | Other | Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy Receives: Other: Non-surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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
Measured: 6 months
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
Measured: 12 months
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
Measured: 24 months
Secondary outcomes (11)
Ultrasonography (US)
Achilles tendon length - measured using US extended field of view
Measured: 6 months
Ultrasonography (US)
Achilles tendon length - measured using US extended field of view
Measured: 12 months
Ultrasonography (US)
Achilles tendon length - measured using US extended field of view
Measured: 24 months
Achilles Tendon Rupture Score (ATRS)
Patient reported outcome measure (PROM) specific for achilles tendon rupture
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 24 months
Physical Activity Scale (PAS)
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Measured: 3 months
Physical Activity Scale (PAS)
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Measured: 6 months
Physical Activity Scale (PAS)
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Measured: 12 months
Physical Activity Scale (PAS)
PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Aug 2020
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Nilsson Helander, Sahlgrenska University Hospital
- Investigators
- Katarina Nilsson Helander, MD Ass Prof., Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420832
- Sponsor's protocol ID
- ATR ultrasound study
- Acronym
- DUSTAR
- Status last verified
- May 2024
- First submitted
- 17 May 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture
- ClinicalTrials.gov ID
- NCT04420832
- Acronym / sponsor ID
- DUSTAR / ATR ultrasound study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Active comparator | Procedure: Surgical treatmentPatients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy |
| Non-surgical treatment | Other | Other: Non-surgical treatmentPatients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- acute achilles tendon rupture diagnosed less than 48 hours from injury
- mid-substance rupture
Key exclusion criteria (6 listed)
- previous achilles tendon rupture
- lower leg disability
- diabetes mellitus
- neurovascular disease
- immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatmentSe above | Procedure or surgery | Surgical treatment |
| Non-surgical treatmentSee above | Other | Non-surgical treatment |
Primary outcome
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.
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
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
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
11 secondary outcomes
Ultrasonography (US)
Time frame: 6 months
Ultrasonography (US)
Time frame: 12 months
Ultrasonography (US)
Time frame: 24 months
Achilles Tendon Rupture Score (ATRS)
Time frame: 3 months
Achilles Tendon Rupture Score (ATRS)
Time frame: 6 months
Achilles Tendon Rupture Score (ATRS)
Time frame: 12 months
Achilles Tendon Rupture Score (ATRS)
Time frame: 24 months
Physical Activity Scale (PAS)
Time frame: 3 months
Physical Activity Scale (PAS)
Time frame: 6 months
Physical Activity Scale (PAS)
Time frame: 12 months
Physical Activity Scale (PAS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarina Nilsson Helander, MD Ass Prof. principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment and Non-surgical treatment in people with Achilles Tendon Rupture and Athletic Injuries, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in functional outcome between patients treated surgically and non-surgically (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.