The Impact of Obesity on Short Stem Total Hip Arthroplasty

Obesity Clinical Trial

Official title:

Obesity and it's Impact on Subsidence and Clinical Outcomes After Short Stem Total Hip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06430723
• Other study ID #: EK 1258/2023
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2024
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty.

Description:

Short stem total hip arthroplasty (THA) has gained popularity due to its bone-sparing technique, but its outcomes in obese patients remain uncertain.

While studies on the mid-term outcome in a general patient cohort provide excellent results in terms of the clinical and radiological outcome as well as the complication rate of short stem THA, data on its use in obese patients is still rare and not sufficiently conclusive. Some studies have found no evidence of increased subsidence in obese patients, while other studies have shown contrary trends.

In this context, the aim of this study was to investigate the relationship between BMI, postoperative subsidence and clinical outcomes in the setting of short stem THA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. patients who underwent primary short stem hip arthroplasty with Mathys Optimys short stem between 01.01.2018 and 31.12.2020

2. availability of preoperative and postoperative radiographs for assessment of subsidence

3. a minimum BMI of 30kg/m2 for the obese group

4. a minimum follow-up of 24 months.

Exclusion Criteria:

1. former surgeries of the hip in question

2. incomplete clinical data

3. incomplete radiological data

Related Conditions & MeSH terms

• Obesity
• THA

Intervention

Procedure:
• Total hip arthroplasty
Total hip arthroplasty using short stem via an minimally invasive anterolateral approach

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie	Linz

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subsidence	subsidence of the short stem measured via EBRA (Einzelbild Röntgenanalyse), [mm]	2 years
Primary	Harris Hip Score	Clinical outcome, [0-100points]	2 years
Secondary	surgery time	Surgery time from cut to skin closure, [minutes]	2 years
Secondary	Length of stay	Length of postoperative stay in hospital [days]	2 years
Secondary	Blood loss	Blood loss calculated according to laboratory test results of hematocrit [ml]	2 years