- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406271
Hip Prosthesis Components Position
June 1, 2022 updated by: Mateusz Szymczak
Influence of Use of Intraoperative Fluoroscopy on the Hip Prosthesis Components Position
The purpose of the study is
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
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 Contact
- Name: Karol Elster, MD, Phd
- Phone Number: +48662128773
- Email: karol.elster@gmail.com
Study Locations
-
-
Kujawsko-pomorskie
-
Rypin, Kujawsko-pomorskie, Poland, 87-500
- District Hospital
-
Contact:
- Karol Elster, MD, Phd
- Phone Number: +48662128773
- Email: karol.elster@gmail.com
-
Principal Investigator:
- Karol Elster, MD, Phd
-
Sub-Investigator:
- Mateusz Błaszczyk, MD
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- indication for hip replacement surgery
Exclusion Criteria:
- pregnancy
- abnormal anatomy (hip dysplasia, fracture)
- previous srgery
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hip Prosthesis with intraoperative fluoroscopy
|
Impantation of hip prosthesis with intraoperative fluoroscopy
|
No Intervention: Hip Prosthesis without intraoperative fluoroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prosthesis cup position
Time Frame: Day 1 after surgery
|
inclination, anteversion, centre of rotation of the prosthesis cup.
Measurement will be made on post x-rays
|
Day 1 after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prosthesis steam position
Time Frame: Day 1 after surgery
|
Leg length, total offset of the hip prosthesis.
Measurement will be made on post x-rays
|
Day 1 after surgery
|
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 (Anticipated)
June 1, 2022
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
June 1, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (Actual)
June 6, 2022
Study Record Updates
Last Update Posted (Actual)
June 6, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123 (Giresun University Scientific Research Project)
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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