Femoral Head SizejantjeNCT04637958
Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty
An observational study of Femoral Head Size and Cup Size THP, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
We want to investigate the correlation between the native femoral head and the implanted cup in Total hip arthroplasty. As second parameter to investigate we believe an oversized cup will cause groin pain. We want to find a cutoff value to predict groin pain after cup implementation in THA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Head Size, Cup Size THP, Postoperatie Groin Pain
- What is being tested?
- THA
- Type of treatment
- Medical device
- How many people
- 463 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2014to Jul 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: retrospective database THA
Who may be able to join
- all primary THA
Who cannot join
- DDH-LCP
- Acetabulum/femoral neck fracture
Trial locations and contacts
1 site in 1 country.
About this study
We want to investigate the correlation between the native femoral head and the implanted cup in Total hip arthroplasty. As second parameter to investigate we believe an oversized cup will cause groin pain. We want to find a cutoff value to predict groin pain after cup implementation in THA.
- Conditions
- Femoral Head Size, Cup Size THP, Postoperatie Groin Pain
- Being tested
- THA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THADevice
Total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| pain | THA Receives: Device: THA | |
| no pain | THA Receives: Device: THA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between femoral head and cup size and postoperative pain in Total Hip arthroplasty
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoral Head SizeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Research Orthopedie, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637958
- Sponsor's protocol ID
- JBFemHeadTHP
- Other IDs
- UZ Leuven
- Acronym
- jantje
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Odri GA, Padiolleau GB, Gouin FT. Oversized cups as a major risk factor of postoperative pain after total hip arthroplasty. J Arthroplasty. 2014 Apr;29(4):753-6. doi: 10.1016/j.arth.2013.07.001. Epub 2013 Aug 6.
PubMed 23927907
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04637958
- Acronym / sponsor ID
- jantje / JBFemHeadTHP
- Conditions
- Femoral Head Size, Cup Size THP, Postoperatie Groin Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Nov 2020 (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.
We want to investigate the correlation between the native femoral head and the implanted cup in Total hip arthroplasty. As second parameter to investigate we believe an oversized cup will cause groin pain. We want to find a cutoff value to predict groin pain after cup implementation in THA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pain | – | Device: THATHA |
| no pain | – | Device: THATHA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- retrospective database THA
Key inclusion criteria (1 listed)
- all primary THA
Key exclusion criteria (2 listed)
- DDH-LCP
- Acetabulum/femoral neck fracture
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 |
|---|---|---|
| THATotal hip arthroplasty | Device | no pain, pain |
Primary outcome
Correlation between femoral head and cup size and postoperative pain in Total Hip arthroplasty
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Background: PubMed 23927907Odri GA, Padiolleau GB, Gouin FT. Oversized cups as a major risk factor of postoperative pain after total hip arthroplasty. J Arthroplasty. 2014 Apr;29(4):753-6. doi: 10.1016/j.arth.2013.07.001. Epub 2013 Aug 6.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Head Size and Cup Size THP, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 20 Nov 2020. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between femoral head and cup size and postoperative pain in Total Hip arthroplasty (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637958, which also lists 1 linked publication.
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 20 Nov 2020.