Hip ArthrosisNCT05406271
Hip Prosthesis Components Position
A study testing Intraoperative fluoroscopy in people with Hip Arthrosis, run by Mateusz Szymczak at 1 site in Poland.
Trial summary
The purpose of the study is Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthrosis
- What is being tested?
- Intraoperative fluoroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for hip replacement surgery
Who cannot join
- pregnancy
- abnormal anatomy (hip dysplasia, fracture)
- previous srgery
Trial locations and contacts
1 site in 1 country.
Poland1 site
District Hospital
Rypin, Kuyavian-Pomeranian Voivodeship, 87-500
Karol Elster, MD, Phd, +48662128773, karol.elster@gmail.com
Karol Elster, MD, Phd
About this study
Official title: Influence of Use of Intraoperative Fluoroscopy on the Hip Prosthesis Components Position
The purpose of the study is
- Conditions
- Hip Arthrosis
- Being tested
- Intraoperative fluoroscopy
- Keywords
- hip prosthesis, center of rotation, offset
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative fluoroscopyDiagnostic test
Impantation of hip prosthesis with intraoperative fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Hip Prosthesis with intraoperative fluoroscopy | Experimental | Not described Receives: Diagnostic Test: Intraoperative fluoroscopy |
| Hip Prosthesis without intraoperative fluoroscopy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis cup position
inclination, anteversion, centre of rotation of the prosthesis cup. Measurement will be made on post x-rays
Measured: Day 1 after surgery
Secondary outcomes (1)
Prosthesis steam position
Leg length, total offset of the hip prosthesis. Measurement will be made on post x-rays
Measured: Day 1 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mateusz Szymczak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mateusz Szymczak, Independent Public Healthcare Center in Rypin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406271
- Sponsor's protocol ID
- 123
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Use of Intraoperative Fluoroscopy on the Hip Prosthesis Components Position
- ClinicalTrials.gov ID
- NCT05406271
- Acronym / sponsor ID
- 123
- Conditions
- Hip Arthrosis
- Keywords
- hip prosthesis, center of rotation, offset
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mateusz SzymczakUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Prosthesis with intraoperative fluoroscopy | Experimental | Diagnostic Test: Intraoperative fluoroscopy |
| Hip Prosthesis without intraoperative fluoroscopy | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for hip replacement surgery
Key exclusion criteria (3 listed)
- pregnancy
- abnormal anatomy (hip dysplasia, fracture)
- previous srgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative fluoroscopyImpantation of hip prosthesis with intraoperative fluoroscopy | Diagnostic test | Hip Prosthesis with intraoperative fluoroscopy |
Primary outcome
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
1 secondary outcome
Prosthesis steam position
Time frame: Day 1 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative fluoroscopy in people with Hip Arthrosis, run by Mateusz Szymczak at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karol Elster, MD, Phd (+48662128773, karol.elster@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthesis cup position (time frame: Day 1 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.