DEXA Bone Density Analysis of the CoreHip® Prosthesis System

N/ANot Yet RecruitingNCT06632301

Aesculap AG40 enrolled

Overview

The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary cementless stem. The DEXA bone density analysis is used.

Additional diagnostic examination: DEXA-Analysis. A DEXA scan is an imaging test that measures bone density (strength). The results can provide helpful details about risk for osteoporosis (bone loss) and fractures. Furthermore we would like to find out more about stress shielding processes around our prosthesis.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Primary Osteoarthritis Cartilage Degeneration Osteoarthritis, Hip Inflammatory Arthritis Osteonecrosis of Femoral Head Traumatic Disorder

Interventions

Primary hip replacement with cementless stemDEVICE

Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Unilateral hip osteoarthritis * Indication for CoreHip Standard hip stem according to preoperative planning * Written Informed Consent * Age 35-85 years * According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits Exclusion Criteria: * Femoral neck fractures * Pregnancy * BMI \> 35 * History of femoral fracture or previous surgery on the same hip * Metabolic bone disease, use of steroids or other drugs affecting bone metabolism * Intraoperative bone cracks * Severe osteoarthritis of the contralateral hip * THA of the contralateral side or other event leading to restricted weight bearing during the study period

Locations (1)

Medizinische Hochschule Hannover

Hanover, Germany

Outcomes

Primary Outcomes

Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)

Changes in bone mineral density (BMD) according to Gruen.

Time frame: within 24 months postoperative

Secondary Outcomes

Clinical Results: Joint Function (Harris Hip Score)

The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time.