CoxarthrosisNCT04623073
EO Footprint as a Landmark During DAA THA
An observational study of Coxarthrosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
One of the goals of Total Hip Arthroplasty (THA) is to reconstruct leg length as adequately as possible. In order to achieve this one needs landmarks that are visible both on the templating X ray as well as during surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- Total Hip arthroplasty via a Direct Anterior Approach
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 29 Apr 2021
- 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: All patient who underwent THA via DAA by a single surgeon who routinely documents the distance from the shoulder of the stem to the upper border of the EO tendon
Who may be able to join
- All patient who underwent THA via DAA by a single surgeon who routinely documents the distance from the shoulder of the stem to the upper border of the EO tendon
Who cannot join
- Distance not noted
- No radiographs available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The External Obturator Footprint as a Landmark for Stem Dept - Clinical Validation
One of the goals of Total Hip Arthroplasty (THA) is to reconstruct leg length as adequately as possible. In order to achieve this one needs landmarks that are visible both on the templating X ray as well as during surgery. The classical posterior and lateral approaches often rely on the distance from the greater trochanter (GT) to the shoulder of the femoral stem or the distance from the lesser trochanter (LT) to the side of the neck osteotomy. If the surgeon finds out on the digital template that the distance from the GT to the shoulder of the implant should be X mm to achieve equal leg length, than the surgeon can try to reconstruct this during surgery. During the Direct Anterior Approach (DAA) these landmarks usually are not visible or require additional dissection injuring important soft tissue structures along the way. One anatomical structure that appears to be always visible during the DAA is the External Obturator tendon (EO). It was recently confirmed that the level of insertion of the EO onto the proximal femur can also always be determined on pre-operative X rays. It therefore represents one of the few landmarks that is visible both on the templating X ray as well as during DAA THA. Indeed, many hip surgeons, including ourselves, believe that if the shoulder of the femoral stem is near the insertion of the EO leg length cannot be far off. However, there is no clinical data to support this. The investigators would therefore like to the correlate the distance observed intra-operatively to the actual established distance on the post-operative X ray.
- Conditions
- Coxarthrosis
- Being tested
- Total Hip arthroplasty via a Direct Anterior Approach
- Keywords
- Total hip Arthroplasty, leg length, templating, direct anterior approach, external obturator footprint
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip arthroplasty via a Direct Anterior ApproachProcedure or surgery
Total Hip arthroplasty via a Direct Anterior Approach
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent DAA THA | Patients who underwent DAA THA by a single surgeon who routinely documents the distance from the should of the stem to the upper end of the EO footprint Receives: Procedure: Total Hip arthroplasty via a Direct Anterior Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the distance measured intra-operatively and presumed distance on the pelvic radiographs
Measured: 2 days
Secondary outcomes (2)
Visibility of the EO tendon intra-operatively
Measured: 2 days
Inter and intra-rater reliability
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jan 2021
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CoxarthrosisStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623073
- Sponsor's protocol ID
- S63944
- Status last verified
- Dec 2023
- First submitted
- 3 Nov 2020
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rudiger HA, Fritz B, Impellizzeri FM, Leunig M, Pfirrmann CW, Sutter R. The external obturator footprint as a landmark in total hip arthroplasty through a direct anterior approach: a CT-based analysis. Hip Int. 2019 Jan;29(1):96-101. doi: 10.1177/1120700018761320. Epub 2018 May 21.
PubMed 29783889Vles G, Meynen A, De Mulder J, Ghijselings S. The External Obturator Footprint Is a Usable, Accurate, and Reliable Landmark for Stem Depth in Direct Anterior THA. Clin Orthop Relat Res. 2021 Aug 1;479(8):1842-1848. doi: 10.1097/CORR.0000000000001799.
PubMed 33944807
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The External Obturator Footprint as a Landmark for Stem Dept - Clinical Validation
- ClinicalTrials.gov ID
- NCT04623073
- Acronym / sponsor ID
- S63944
- Conditions
- Coxarthrosis
- Keywords
- Total hip Arthroplasty, leg length, templating, direct anterior approach, external obturator footprint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 10 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.
One of the goals of Total Hip Arthroplasty (THA) is to reconstruct leg length as adequately as possible. In order to achieve this one needs landmarks that are visible both on the templating X ray as well as during surgery. The classical posterior and lateral approaches often rely on the distance from the greater trochanter (GT) to the shoulder of the femoral stem or the distance from the lesser trochanter (LT) to the side of the neck osteotomy. If the surgeon finds out on the digital template that the distance from the GT to the shoulder of the implant should be X mm to achieve equal leg length, than the surgeon can try to reconstruct this during surgery. During the Direct Anterior Approach (DAA) these landmarks usually are not visible or require additional dissection injuring important soft tissue structures along the way. One anatomical structure that appears to be always visible during the DAA is the External Obturator tendon (EO). It was recently confirmed that the level of insertion of the EO onto the proximal femur can also always be determined on pre-operative X rays. It therefore represents one of the few landmarks that is visible both on the templating X ray as well as during DAA THA. Indeed, many hip surgeons, including ourselves, believe that if the shoulder of the femoral stem is near the insertion of the EO leg length cannot be far off. However, there is no clinical data to support this. The investigators would therefore like to the correlate the distance observed intra-operatively to the actual established distance on the post-operative X ray.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent DAA THA | – | Procedure: Total Hip arthroplasty via a Direct Anterior ApproachPatients who underwent DAA THA by a single surgeon who routinely documents the distance from the should of the stem to the upper end of the EO footprint |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient who underwent THA via DAA by a single surgeon who routinely documents the distance from the shoulder of the stem to the upper border of the EO tendon
Key inclusion criteria (1 listed)
- All patient who underwent THA via DAA by a single surgeon who routinely documents the distance from the shoulder of the stem to the upper border of the EO tendon
Key exclusion criteria (2 listed)
- Distance not noted
- No radiographs available
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 |
|---|---|---|
| Total Hip arthroplasty via a Direct Anterior ApproachTotal Hip arthroplasty via a Direct Anterior Approach | Procedure or surgery | Patients who underwent DAA THA |
Primary outcome
Correlation between the distance measured intra-operatively and presumed distance on the pelvic radiographs
Time frame: 2 days
2 secondary outcomes
Visibility of the EO tendon intra-operatively
Time frame: 2 days
Inter and intra-rater reliability
Time frame: 2 days
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 27 Jun 2024.
- Background: PubMed 29783889Rudiger HA, Fritz B, Impellizzeri FM, Leunig M, Pfirrmann CW, Sutter R. The external obturator footprint as a landmark in total hip arthroplasty through a direct anterior approach: a CT-based analysis. Hip Int. 2019 Jan;29(1):96-101. doi: 10.1177/1120700018761320. Epub 2018 May 21.
- Derived from this study: PubMed 33944807Vles G, Meynen A, De Mulder J, Ghijselings S. The External Obturator Footprint Is a Usable, Accurate, and Reliable Landmark for Stem Depth in Direct Anterior THA. Clin Orthop Relat Res. 2021 Aug 1;479(8):1842-1848. doi: 10.1097/CORR.0000000000001799.
- Individual participant dataSharing planned: No
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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.
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 Coxarthrosis, 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 27 Jun 2024. 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 the distance measured intra-operatively and presumed distance on the pelvic radiographs (time frame: 2 days). 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 NCT04623073, which also lists 2 linked publications.
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 27 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.