NCT04623073

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
Last Updated

June 27, 2024

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

November 3, 2020

Last Update Submit

June 26, 2024

Conditions

Keywords

Total hip Arthroplastyleg lengthtemplatingdirect anterior approachexternal obturator footprint

Outcome Measures

Primary Outcomes (1)

  • Correlation between the distance measured intra-operatively and presumed distance on the pelvic radiographs

    2 days

Secondary Outcomes (2)

  • Visibility of the EO tendon intra-operatively

    2 days

  • Inter and intra-rater reliability

    2 days

Study Arms (1)

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

Procedure: Total Hip arthroplasty via a Direct Anterior Approach

Interventions

Total Hip arthroplasty via a Direct Anterior Approach

Patients who underwent DAA THA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Distance not noted
  • No radiographs available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven - Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 29783889BACKGROUND
  • 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.

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 10, 2020

Study Start

January 1, 2021

Primary Completion

April 29, 2021

Study Completion

April 29, 2021

Last Updated

June 27, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations