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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014