Achilles Tendon RuptureNoArcNCT03704532
Nonoperative Treatment of Acute Achilles Tendor Rupture
An observational study of Achilles Tendon Rupture, run by Central Finland Hospital District at 1 site in Finland.
Trial summary
A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Operative treatment and Nonoperative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 1 Apr 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients having sustained an acute achilles tendon rupture and referred for either operative or nonoperative treatment with functional rehabilitation at our institution.
Who may be able to join
- acute achilles tendon rupture with clear onset of symptoms
- closed rupture
- resides in the catchment area of our hospital district
Who cannot join
- avulsion fractures in the calcaneus
- unwillingness to participate
- inability to communicate using Finnish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nonoperative Treatment of Acute Achilles Tendor Rupture in Central Finland: Prospective Cohort Study
A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Operative treatment, Nonoperative treatment
- Keywords
- achilles tendon rupture, nonoperative treatment, functional rehabilitation, operative treatment, biomechanical measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative treatmentProcedure or surgery
Open surgical repair of tendon rupture
Nonoperative treatmentProcedure or surgery
Nonoperative treatment with lower leg orthosis and functional rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Operative treatment | Patients having undergone an operative treatment of achilles tendon rupture Receives: Procedure: Operative treatment | |
| Nonoperative treatment | Patients having undergone a nonoperative treatment with functional rehabilitation of achilles tendon rupture Receives: Procedure: Nonoperative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rerupture rate
Rate rerupture of a healed tendon after the end of the intervention
Measured: 1 year
Secondary outcomes (7)
Physical Activity Level
Patient activity 1 year after the rupture using the Tegner activity level scale which varies from 0 to 10. This scale that aims to provide a standardized method of grading work and sporting activities.
Measured: 1 year
University of California, Los Angeles (UCLA) score
Patient activity 1 year after the rupture
Measured: 1 year
Achilles tendon rupture score (ATRS)
Achilles tendon rupture score 1 year after the rupture
Measured: 1 year
Functional Score
Leppilahti score measuring subjective and objective functional outcome 1 year after the rupture on a scale 0-100.
Measured: 1 year
Foot inversion
Foot inversion angle in rest
Measured: 1 year
Foot flexion-extension
Foot flexion-extension angle in rest
Measured: 1 year
Heel-raise test
One leg heel-raise test while standing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Apr 2017
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jyvaskyla
- Responsible party
- Sponsor
- Investigators
- Juha Paloneva, MD, PhD, Study chair, Central Finland Health Care District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704532
- Sponsor's protocol ID
- 2U/2018
- Acronym
- NoArc
- Status last verified
- Feb 2024
- First submitted
- 10 Oct 2018
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sukanen M, Khair RM, Laatikainen-Raussi I, Reito A, Ponkilainen V, Cronin NJ, Hautala AJ, Finni T. Achilles Tendon Shear Wave Velocity Within a 1-Year Follow-Up After Non-Operatively Treated Rupture. J Orthop Res. 2026 Apr;44(4):e70201. doi: 10.1002/jor.70201.
PubMed 41918467Sukanen M, Khair RM, Reito A, Ponkilainen V, Paloneva J, Cronin N, Hautala AJ, Finni T. Early Predictors of Recovery From Nonoperatively Treated Achilles Tendon Rupture: 1 Year Follow-Up Study. Scand J Med Sci Sports. 2024 Jul;34(7):e14700. doi: 10.1111/sms.14700.
PubMed 39010659
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonoperative Treatment of Acute Achilles Tendor Rupture in Central Finland: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03704532
- Acronym / sponsor ID
- NoArc / 2U/2018
- Conditions
- Achilles Tendon Rupture
- Keywords
- achilles tendon rupture, nonoperative treatment, functional rehabilitation, operative treatment, biomechanical measurements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Collaborators
- University of Jyvaskyla
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Oct 2018 (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.
A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative treatment | – | Procedure: Operative treatmentPatients having undergone an operative treatment of achilles tendon rupture |
| Nonoperative treatment | – | Procedure: Nonoperative treatmentPatients having undergone a nonoperative treatment with functional rehabilitation of achilles tendon rupture |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients having sustained an acute achilles tendon rupture and referred for either operative or nonoperative treatment with functional rehabilitation at our institution.
Key inclusion criteria (3 listed)
- acute achilles tendon rupture with clear onset of symptoms
- closed rupture
- resides in the catchment area of our hospital district
Key exclusion criteria (3 listed)
- avulsion fractures in the calcaneus
- unwillingness to participate
- inability to communicate using Finnish language
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 |
|---|---|---|
| Operative treatmentOpen surgical repair of tendon rupture | Procedure or surgery | Operative treatment |
| Nonoperative treatmentNonoperative treatment with lower leg orthosis and functional rehabilitation | Procedure or surgery | Nonoperative treatment |
Primary outcome
Rerupture rate
Time frame: 1 year
Rate rerupture of a healed tendon after the end of the intervention
7 secondary outcomes
Physical Activity Level
Time frame: 1 year
University of California, Los Angeles (UCLA) score
Time frame: 1 year
Achilles tendon rupture score (ATRS)
Time frame: 1 year
Functional Score
Time frame: 1 year
Foot inversion
Time frame: 1 year
Foot flexion-extension
Time frame: 1 year
Heel-raise test
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 41918467Sukanen M, Khair RM, Laatikainen-Raussi I, Reito A, Ponkilainen V, Cronin NJ, Hautala AJ, Finni T. Achilles Tendon Shear Wave Velocity Within a 1-Year Follow-Up After Non-Operatively Treated Rupture. J Orthop Res. 2026 Apr;44(4):e70201. doi: 10.1002/jor.70201.
- Derived from this study: PubMed 39010659Sukanen M, Khair RM, Reito A, Ponkilainen V, Paloneva J, Cronin N, Hautala AJ, Finni T. Early Predictors of Recovery From Nonoperatively Treated Achilles Tendon Rupture: 1 Year Follow-Up Study. Scand J Med Sci Sports. 2024 Jul;34(7):e14700. doi: 10.1111/sms.14700.
- 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.
Juha Paloneva, MD, PhD study chair
Central Finland Health Care District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon Rupture, run by Central Finland Hospital District at 1 site in Finland.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 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 Finland. 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?
Results are not available in the source record.
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?
Rerupture rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704532, which also lists 2 linked publications.
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 13 Feb 2024.