NCT01778816

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

January 25, 2013

Last Update Submit

January 25, 2013

Conditions

Achilles Tendon Ruptures

Keywords

Achilles tendon, muscle volume, Achilles tendon length, force, ATRS, Hannover, AOFAS

Outcome Measures

Primary Outcomes (1)

  • Muscle Volume

    at least 3 years after injury

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Age 20-65 years * BMI \< 40 * no injury to leg * no injury on contralateral leg

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • body mass index (BMI) of \> 40 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Claudio Rosso MD MSc

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

December 1, 2011

Last Updated

January 29, 2013

Record last verified: 2013-01