- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04623073
The External Obturator Footprint as a Landmark for Stem Depth in Direct Anterior Total Hip Arthroplasty - Clinical Validation
March 1, 2021 updated by: Universitaire Ziekenhuizen KU Leuven
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leuven, Belgium, 3000
- University Hospitals Leuven - Gasthuisberg
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Distance not noted
- No radiographs available
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Total Hip arthroplasty via a Direct Anterior Approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between the distance measured intra-operatively and presumed distance on the pelvic radiographs
Time Frame: 2 days
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visibility of the EO tendon intra-operatively
Time Frame: 2 days
|
2 days
|
Inter and intra-rater reliability
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Vles 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.
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 (Actual)
January 1, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
November 3, 2020
First Submitted That Met QC Criteria
November 3, 2020
First Posted (Actual)
November 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- s63944
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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