NCT06430723

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 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

Study Start

First participant enrolled

January 1, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

6 years

First QC Date

May 21, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

subsidenceobesityshort stem total hip arthroplastytha

Outcome Measures

Primary Outcomes (2)

  • Subsidence

    subsidence of the short stem measured via EBRA (Einzelbild Röntgenanalyse), \[mm\]

    2 years

  • Harris Hip Score

    Clinical outcome, \[0-100points\]

    2 years

Secondary Outcomes (3)

  • surgery time

    2 years

  • Length of stay

    2 years

  • Blood loss

    2 years

Study Arms (2)

Non-obese

Body mass index \< 30 kg/m2

Procedure: Total hip arthroplasty

Obese

Body mass index \>= 30 kg/m2

Procedure: Total hip arthroplasty

Interventions

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

Non-obeseObese

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • patients who underwent primary short stem hip arthroplasty with Mathys Optimys short stem between 01.01.2018 and 31.12.2020
  • availability of preoperative and postoperative radiographs for assessment of subsidence
  • a minimum BMI of 30kg/m2 for the obese group
  • a minimum follow-up of 24 months.

You may not qualify if:

  • former surgeries of the hip in question
  • incomplete clinical data
  • incomplete radiological data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie

Linz, 4010, Austria

Location

MeSH Terms

Conditions

Obesity

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

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

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 28, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations