Acute Unilateral Rupture of the Achilles TendonACHILLENCT03308760
Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
An observational study of Acute Unilateral Rupture of the Achilles Tendon, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the usual treatment in young subjects, and although the optimal technique is still a matter of debate, conventional surgery with a direct approach is still the reference technique in young sportsmen and women. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acute Unilateral Rupture of the Achilles Tendon
- What is being tested?
- Questionnaire, Static stabilometry and Isokinetic test
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Dec 2014
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients followed at the Convalescence and Rehabilitation Unit of Dijon CHU
Who may be able to join
- persons informed about the research
- sportsmen and women (competition or leisure, practiced > 3h/week)
- Between 18 and 45 years old
- First episode of acute traumatic unilateral rupture of the Achilles tendon
- Open surgery in the Orthopaedic and Traumatology Department of Dijon University Hospital
- Identical post-operative immobilisation programme for 6 weeks
- Absence of major post-operative complications delaying the rehabilitation
Who cannot join
- persons without national health insurance cover
- concomitant joint disease that could be aggravated by the tests
- heart disease/contra-indication to effort required during the isokinetic test
- management other than open surgery (orthopaedic, functional, percutaneous surgery, …)
- Rupture of the contralateral tendon
- Contra-indication for the use of the Biodex S4 pro
Trial locations and contacts
1 site in 1 country.
About this study
Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the usual treatment in young subjects, and although the optimal technique is still a matter of debate, conventional surgery with a direct approach is still the reference technique in young sportsmen and women. Studies investigating the evolution of ankle muscle strength following surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to determine the possibility of returning to the sport. This project thus proposes to study, in comparison with the healthy ankle:(1) the evolution of muscle strength in the flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12 months, following surgery for acute unilateral rupture of the Achilles tendon, operated on using the conventional technique in young sportsmen and women and in comparison with the healthy side.
- Being tested
- Questionnaire, Static stabilometry, Isokinetic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Interview concerning the post-operative rehabilitation programme and a functional analysis using the American Orthopaedic Foot and Ankle Society questionnaire
Static stabilometryOther
on a force plate, in a double- then single-foot stance, with the eyes open and then closed
Isokinetic testOther
Isokinetic test of the flexors/extensors and invertors/evertors of the ankle
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
measured on the healthy and injured side using an isokinetic dynamometer
Measured: 6 months
Postural parameters measured using a stabilometry platform
measured using a stabilometry platform
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study startDec 2012
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Unilateral Rupture of the Achilles TendonStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308760
- Sponsor's protocol ID
- GREMEAUX 2013
- Acronym
- ACHILLE
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
- ClinicalTrials.gov ID
- NCT03308760
- Acronym / sponsor ID
- ACHILLE / GREMEAUX 2013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Oct 2017 (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.
Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the usual treatment in young subjects, and although the optimal technique is still a matter of debate, conventional surgery with a direct approach is still the reference technique in young sportsmen and women. Studies investigating the evolution of ankle muscle strength following surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to determine the possibility of returning to the sport. This project thus proposes to study, in comparison with the healthy ankle:(1) the evolution of muscle strength in the flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12 months, following surgery for acute unilateral rupture of the Achilles tendon, operated on using the conventional technique in young sportsmen and women and in comparison with the healthy side.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients followed at the Convalescence and Rehabilitation Unit of Dijon CHU
Key inclusion criteria (7 listed)
- persons informed about the research
- sportsmen and women (competition or leisure, practiced > 3h/week)
- Between 18 and 45 years old
- First episode of acute traumatic unilateral rupture of the Achilles tendon
- Open surgery in the Orthopaedic and Traumatology Department of Dijon University Hospital
Key exclusion criteria (6 listed)
- persons without national health insurance cover
- concomitant joint disease that could be aggravated by the tests
- heart disease/contra-indication to effort required during the isokinetic test
- management other than open surgery (orthopaedic, functional, percutaneous surgery, …)
- Rupture of the contralateral tendon
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 |
|---|---|---|
| QuestionnaireInterview concerning the post-operative rehabilitation programme and a functional analysis using the American Orthopaedic Foot and Ankle Society questionnaire | Other | – |
| Static stabilometryon a force plate, in a double- then single-foot stance, with the eyes open and then closed | Other | – |
| Isokinetic testIsokinetic test of the flexors/extensors and invertors/evertors of the ankle | Other | – |
Primary outcome
Muscle strength
Time frame: 6 months
measured on the healthy and injured side using an isokinetic dynamometer
Postural parameters measured using a stabilometry platform
Time frame: 6 months
measured using a stabilometry platform
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Unilateral Rupture of the Achilles Tendon, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 13 Oct 2017. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle strength (time frame: 6 months). The study lists 2 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 13 Oct 2017.