Back to resultsHip Prosthesis Components Position
Primary Purpose
Hip Arthrosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intraoperative fluoroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthrosis focused on measuring hip prosthesis, center of rotation, offset
Eligibility Criteria
Inclusion Criteria:
- indication for hip replacement surgery
Exclusion Criteria:
- pregnancy
- abnormal anatomy (hip dysplasia, fracture)
- previous srgery
Sites / Locations
- District Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hip Prosthesis with intraoperative fluoroscopy
Hip Prosthesis without intraoperative fluoroscopy
Arm Description
Outcomes
Primary Outcome Measures
Prosthesis cup position
inclination, anteversion, centre of rotation of the prosthesis cup. Measurement will be made on post x-rays
Secondary Outcome Measures
Prosthesis steam position
Leg length, total offset of the hip prosthesis. Measurement will be made on post x-rays
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05406271
Brief Title
Hip Prosthesis Components Position
Official Title
Influence of Use of Intraoperative Fluoroscopy on the Hip Prosthesis Components Position
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mateusz Szymczak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthrosis
Keywords
hip prosthesis, center of rotation, offset
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hip Prosthesis with intraoperative fluoroscopy
Arm Type
Experimental
Arm Title
Hip Prosthesis without intraoperative fluoroscopy
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Intraoperative fluoroscopy
Intervention Description
Impantation of hip prosthesis with intraoperative fluoroscopy
Primary Outcome Measure Information:
Title
Prosthesis cup position
Description
inclination, anteversion, centre of rotation of the prosthesis cup. Measurement will be made on post x-rays
Time Frame
Day 1 after surgery
Secondary Outcome Measure Information:
Title
Prosthesis steam position
Description
Leg length, total offset of the hip prosthesis. Measurement will be made on post x-rays
Time Frame
Day 1 after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
indication for hip replacement surgery
Exclusion Criteria:
pregnancy
abnormal anatomy (hip dysplasia, fracture)
previous srgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karol Elster, MD, Phd
Phone
+48662128773
Email
karol.elster@gmail.com
Facility Information:
Facility Name
District Hospital
City
Rypin
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-500
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Elster, MD, Phd
Phone
+48662128773
Email
karol.elster@gmail.com
First Name & Middle Initial & Last Name & Degree
Karol Elster, MD, Phd
First Name & Middle Initial & Last Name & Degree
Mateusz Błaszczyk, MD
12. IPD Sharing Statement
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Hip Prosthesis Components Position
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