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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01778816
Other study ID # RossoAchilles
Secondary ID
Status Completed
Phase N/A
First received January 25, 2013
Last updated January 25, 2013
Start date January 2009
Est. completion date December 2011

Study information

Verified date January 2013
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 2011
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Hospital Fribourg, Switzerland, Hospital Liestal, Switzerland

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Volume at least 3 years after injury No