- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04940754
Ankle Arthrodesis Nail for 2-level Pathologic Tibial Fracture
August 14, 2021 updated by: Orthopaedie Zentrum Zuerich
Ankle Arthrodesis Nail Combined With Locking Compression Plate to Stabilize Two-level Pathologic Tibial Fractures
Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The arthrodesis nail for hind foot problems is used as salvage for tibial fractures after failed plate fixation,
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zürich, Switzerland, 8027
- Orthopaedie Zentrum Zuerich
-
-
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
80 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- old age, fragility fracture, tibia
Exclusion Criteria:
- active osteomyelitis
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Stabilzation of Fracture
Arthrodesis nail used for stabilzation of a fracture, single patient
|
Closed reduction, internal fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight bearing tolerance
Time Frame: 1 year
|
Measuring walking distance
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
April 8, 2021
Primary Completion (Anticipated)
April 8, 2022
Study Completion (Anticipated)
May 8, 2022
Study Registration Dates
First Submitted
June 10, 2021
First Submitted That Met QC Criteria
June 25, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 14, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GUE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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