The External Obturator Footprint as a Landmark for Stem Depth in Direct Anterior Total Hip Arthroplasty - Clinical Validation

Coxarthrosis Clinical Trial

Official title:

The External Obturator Footprint as a Landmark for Stem Depth in Direct Anterior Total Hip Arthroplasty - Clinical Validation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04623073
• Other study ID #: s63944
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Intervention

Procedure:
• Total Hip arthroplasty via a Direct Anterior Approach
Total Hip arthroplasty via a Direct Anterior Approach

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven - Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Rüdiger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the distance measured intra-operatively and presumed distance on the pelvic radiographs		2 days
Secondary	Visibility of the EO tendon intra-operatively		2 days
Secondary	Inter and intra-rater reliability		2 days