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

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.

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

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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