## Protocol Section
### Identification Module
**NCT ID:** NCT06430723

**Brief Title:** The Impact of Obesity on Short Stem Total Hip Arthroplasty

**Official Title:** Obesity and it's Impact on Subsidence and Clinical Outcomes After Short Stem Total Hip

#### Organization Study ID Info
**ID:** EK 1258/2023
#### Organization
**Class:** OTHER
**Full Name:** Krankenhaus Barmherzige Schwestern Linz
### Status Module
#### Completion Date
**Date:** 2024-01-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Krankenhaus Barmherzige Schwestern Linz

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- THA

- Obesity

**Keywords:**

- subsidence

- obesity

- short stem total hip arthroplasty

- tha

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 216

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Body mass index \< 30 kg/m2

**Intervention Names:**

- Procedure: Total hip arthroplasty

**Label:** Non-obese

#### Arm Group 2

**Description:** Body mass index \>= 30 kg/m2

**Intervention Names:**

- Procedure: Total hip arthroplasty

**Label:** Obese

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Non-obese

- Obese

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

**Name:** Total hip arthroplasty

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Subsidence

**Time Frame:** 2 years

**Description:** Clinical outcome, \[0-100points\]

**Measure:** Harris Hip Score

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** Surgery time from cut to skin closure, \[minutes\]

**Measure:** surgery time

**Time Frame:** 2 years

**Description:** Length of postoperative stay in hospital \[days\]

**Measure:** Length of stay

**Time Frame:** 2 years

**Description:** Blood loss calculated according to laboratory test results of hematocrit \[ml\]

**Measure:** Blood loss

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Linz

**Country:** Austria

**Facility:** Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie

**Zip:** 4010

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

### Misc Info Module

- Version Holder: 2024-05-31
