The Impact of Obesity on Short Stem Total Hip Arthroplasty

June 10, 2024 updated by: Krankenhaus Barmherzige Schwestern Linz

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

200

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

  • Austria
      • Linz, Austria, 4010
        • Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The purpose of this study was to assess the subsidence rates in patients who underwent short stem hip arthroplasty and its association with obesity. To investigate this, an analysis of patient data was conducted together with a follow-up examination, focusing on clinical outcome and radiographic analysis of the subsidence of the stem in obese patients. Hence, two groups based on body mass index were retrospectively evaluated: obese (BMI ≥ 30 kg/m^2) and non-obese (BMI < 30 kg/m^2), with an age of minimum 18 years, but no maximum age.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-obese
Body mass index < 30 kg/m2
Procedure: Total hip arthroplasty
Total hip arthroplasty using short stem via an minimally invasive anterolateral approach
Obese
Body mass index >= 30 kg/m2
Procedure: Total hip arthroplasty
Total hip arthroplasty using short stem via an minimally invasive anterolateral approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subsidence
Time Frame: 2 years
subsidence of the short stem measured via EBRA (Einzelbild Röntgenanalyse), [mm]
2 years
Harris Hip Score
Time Frame: 2 years
Clinical outcome, [0-100points]
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgery time
Time Frame: 2 years
Surgery time from cut to skin closure, [minutes]
2 years
Length of stay
Time Frame: 2 years
Length of postoperative stay in hospital [days]
2 years
Blood loss
Time Frame: 2 years
Blood loss calculated according to laboratory test results of hematocrit [ml]
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Barmherzige Schwestern Linz

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, 2018

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 1258/2023

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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