- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778816
Calf Muscle Atrophy After Achilles Tendon Rupture. A Clinical-Radiological-Biomechanical Multicenter Study.
January 25, 2013 updated by: Claudio Rosso, University Hospital, Basel, Switzerland
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
52
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
- Age 20-65 years
- BMI < 40
- no injury to leg
- no injury on contralateral leg
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle Volume
Time Frame: at least 3 years after injury
|
at least 3 years after injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
January 25, 2013
First Submitted That Met QC Criteria
January 25, 2013
First Posted (Estimate)
January 29, 2013
Study Record Updates
Last Update Posted (Estimate)
January 29, 2013
Last Update Submitted That Met QC Criteria
January 25, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RossoAchilles
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Achilles Tendon Ruptures
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Aristotle University Of ThessalonikiGeneral Hospital of Naoussa; Private Orthopedics Practice P. SymeonidisEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon Injury | Achilles Tendon SurgeryGreece
-
Henry Ford Health SystemRecruitingAchilles Tendon Rupture | Achilles Tendon SurgeryUnited States
-
Aarhus University HospitalEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon InjuryDenmark
-
Universidad de GranadaNot yet recruiting
-
University of DelawareActive, not recruitingAchilles Tendinopathy | Achillodynia | Achilles Tendon Pain | Achilles Tendonitis | Achilles DegenerationUnited States
-
NYU Langone HealthWithdrawnRuptured Achilles TendonUnited States
-
Marco Aurélio Vaz, PhDRecruitingMenstrual Cycle | Achilles TendonBrazil
-
SuperSonic ImaginePeking University Third Hospital; Beijing Chao Yang HospitalCompletedAchilles Tendon | Plantar FasciaChina
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University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
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University Hospital, ToursCompletedAlterations of the Achilles TendonFrance