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Calf Muscle Atrophy After Achilles Tendon Rupture. A Clinical-Radiological-Biomechanical Multicenter Study.

This study has been completed.
Sponsor:
Collaborators:
Hospital Fribourg, Switzerland
Hospital Liestal, Switzerland
Information provided by (Responsible Party):
Claudio Rosso, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01778816
First received: January 25, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition
Achilles Tendon Ruptures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Muscle Volume [ Time Frame: at least 3 years after injury ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Age 20-65 years
  • BMI < 40
  • no injury to leg
  • no injury on contralateral leg
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Claudio Rosso, Claudio Rosso MD MSc, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01778816     History of Changes
Other Study ID Numbers: RossoAchilles
Study First Received: January 25, 2013
Last Updated: January 25, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Achilles tendon, muscle volume, Achilles tendon length, force, ATRS, Hannover, AOFAS

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013