Achilles Tendon RupturesNCT01778816
Calf Muscle Atrophy After Achilles Tendon Rupture. A Clinical-Radiological-Biomechanical Multicenter Study.
An observational study of Achilles Tendon Ruptures, run by University Hospital, Basel, Switzerland.
Trial summary
Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types: open, percutaneous and conservative (non-operative) treatments. Comparing force torque measurements, muscle volume and clinical scores. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Achilles Tendon Ruptures
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2011
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Age 20-65 years * BMI < 40 * no injury to leg * no injury on contralateral leg
Who may be able to join
- 20-65 years of age,
- a healthy, contralateral leg
- physiological, clinically determined alignment of the knee, foot and ankle
- no trauma to the healthy leg
- no neuromuscular impairments including muscle dystrophies
- no other posttraumatic injuries or osteoarthritis of the knee, foot or ankle of the affected leg.
Who cannot join
- re-rupture or reoperation of the Achilles tendon
- surgical site infection
- neuromuscular diseases including muscle dystrophies
- ankle valgus of more than 15° or ankle varus of more than 5°
- other known pathologies of the non-affected leg
- general MRI exclusion criteria (e.g. pacemaker, other metal not qualifying for an MRI, tattoos and claustrophobia)
- body mass index (BMI) of > 40 kg/m2
About this study
Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types: open, percutaneous and conservative (non-operative) treatments.
Comparing force torque measurements, muscle volume and clinical scores.
- Conditions
- Achilles Tendon Ruptures
- Keywords
- Achilles tendon, muscle volume, Achilles tendon length, force, ATRS, Hannover, AOFAS
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Volume
Measured: at least 3 years after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RupturesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Fribourg, Switzerland, Hospital Liestal, Switzerland
- Responsible party
- Principal investigator, Claudio Rosso, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778816
- Sponsor's protocol ID
- RossoAchilles
- Status last verified
- Jan 2013
- First submitted
- 25 Jan 2013
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calf Muscle Atrophy After Achilles Tendon Rupture. A Clinical-Radiological-Biomechanical Multicenter Study.
- ClinicalTrials.gov ID
- NCT01778816
- Acronym / sponsor ID
- RossoAchilles
- Conditions
- Achilles Tendon Ruptures
- Keywords
- Achilles tendon, muscle volume, Achilles tendon length, force, ATRS, Hannover, AOFAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Hospital Fribourg, Switzerland, Hospital Liestal, Switzerland
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Jan 2013 (estimated)
- 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.
Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types: open, percutaneous and conservative (non-operative) treatments.
Comparing force torque measurements, muscle volume and clinical scores.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Age 20-65 years * BMI < 40 * no injury to leg * no injury on contralateral leg
Key inclusion criteria (6 listed)
- 20-65 years of age,
- a healthy, contralateral leg
- physiological, clinically determined alignment of the knee, foot and ankle
- no trauma to the healthy leg
- no neuromuscular impairments including muscle dystrophies
Key exclusion criteria (7 listed)
- re-rupture or reoperation of the Achilles tendon
- surgical site infection
- neuromuscular diseases including muscle dystrophies
- ankle valgus of more than 15° or ankle varus of more than 5°
- other known pathologies of the non-affected leg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle Volume
Time frame: at least 3 years after injury
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 29 Jan 2013.
Related trials for Achilles Tendon Ruptures
Not yet recruiting
Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
RecruitingObservational study
Achilles Tendon Rupture Patient Outcomes at 12 Months
Achilles Tendon Rupture
Recruiting
Effect of BFR Rehab After Achilles Tendon Rupture
Achilles Tendon Rupture
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon Ruptures, run by University Hospital, Basel, Switzerland.
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 6 inclusion and 7 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 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 Volume (time frame: at least 3 years after injury). 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 Jan 2013.