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

16 years to 61 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.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Hospital Fribourg, Switzerland
Hospital Liestal, Switzerland

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

Keywords

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.

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