Back to resultsAnkle Arthrodesis Nail for 2-level Pathologic Tibial Fracture
Primary Purpose
Bone Metastases, Fracture Nonunion, Bone Lesion
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
osteosynthesis
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastases focused on measuring fragility fracture, old age
Eligibility Criteria
Inclusion Criteria:
- old age, fragility fracture, tibia
Exclusion Criteria:
- active osteomyelitis
Sites / Locations
- Orthopaedie Zentrum Zuerich
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stabilzation of Fracture
Arm Description
Arthrodesis nail used for stabilzation of a fracture, single patient
Outcomes
Primary Outcome Measures
Weight bearing tolerance
Measuring walking distance
Secondary Outcome Measures
Full Information
NCT ID
NCT04940754
First Posted
June 10, 2021
Last Updated
August 14, 2021
Sponsor
Orthopaedie Zentrum Zuerich
1. Study Identification
Unique Protocol Identification Number
NCT04940754
Brief Title
Ankle Arthrodesis Nail for 2-level Pathologic Tibial Fracture
Official Title
Ankle Arthrodesis Nail Combined With Locking Compression Plate to Stabilize Two-level Pathologic Tibial Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
April 8, 2022 (Anticipated)
Study Completion Date
May 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopaedie Zentrum Zuerich
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures
Detailed Description
The arthrodesis nail for hind foot problems is used as salvage for tibial fractures after failed plate fixation,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases, Fracture Nonunion, Bone Lesion
Keywords
fragility fracture, old age
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Use of an approved implant for expanded application
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stabilzation of Fracture
Arm Type
Other
Arm Description
Arthrodesis nail used for stabilzation of a fracture, single patient
Intervention Type
Procedure
Intervention Name(s)
osteosynthesis
Intervention Description
Closed reduction, internal fixation
Primary Outcome Measure Information:
Title
Weight bearing tolerance
Description
Measuring walking distance
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
80 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- old age, fragility fracture, tibia
Exclusion Criteria:
active osteomyelitis
Facility Information:
Facility Name
Orthopaedie Zentrum Zuerich
City
Zürich
ZIP/Postal Code
8027
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Ankle Arthrodesis Nail for 2-level Pathologic Tibial Fracture
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