DEXA Bone Density Analysis of the CoreHip® Prosthesis System

Not Applicable

Not yet recruiting

• Conditions: Primary Osteoarthritis; Cartilage Degeneration; Osteoarthritis, Hip; Inflammatory Arthritis; Osteonecrosis of Femoral Head; Traumatic Disorder
• Interventions: Device: Primary hip replacement with cementless stem

• Registration Number: NCT06632301
• Lead Sponsor: Aesculap AG

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Study Start: 2025-06
• Primary Completion: 2025-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEXA	Primary hip replacement with cementless stem	DEXA bone density analysis to analyze the loading concept of the CoreHip® Prosthesis System

Primary Outcome Measures

Name	Time	Method
Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)	within 24 months postoperative	Changes in bone mineral density (BMD) according to Gruen.

Secondary Outcome Measures

Name	Time	Method
Development of Forgotten Joint Score	preoperative, at discharge (1 week postop) and 12 months postoperative	The EQ-5D-5L score is a generic score used to document the well-being of the patient.
Clinical Results: Joint Function (Harris Hip Score)	preoperative, at discharge (1 week postop) and 12 months postoperative	The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time.
Development of Quality of Life (EQ-5D-5L)	preoperative, at discharge (1 week postop) and 12 months postoperative	The EQ-5D-5L score is a generic score used to document the well-being of the patient.
Development of Pain	preoperative, at discharge (1 week postop) and 12 months postoperative	Radiological changes in the diaphyseal bone density (DEXA BMD progression over time in all Gruen Zones (Zone 1-7)

Trial Locations

Locations (1)

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany