DEXA Bone Density Analysis of the CoreHip® Prosthesis System (CODEX)

DEXA Bone Density Analysis to Analyze the Loading Concept of the CoreHip® Prosthesis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Arthritis; Osteoarthritis, Hip; Primary Osteoarthritis; Traumatic Disorder; Cartilage Degeneration; Osteonecrosis of Femoral Head
• Intervention / Treatment: Device: Primary hip replacement with cementless stem

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerstin Bergmann; Phone Number: +49746195; Email: info@aesculap.de
• Study Contact Backup: Name: Stefan Maenz; Phone Number: 0746195; Email: info@aesculap.de

Study Locations

• Germany
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
    • Contact: Henning Windhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEXA; DEXA bone density analysis to analyze the loading concept of the CoreHip® Prosthesis System	Device: Primary hip replacement with cementless stem; Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Quality of Life (EQ-5D-5L)	The EQ-5D-5L score is a generic score used to document the well-being of the patient.	preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Forgotten Joint Score	The EQ-5D-5L score is a generic score used to document the well-being of the patient.	preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Pain	The development of pain is measured with the Visual analog scale [VAS] a measure of pain intensity. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale].	preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Pain	Radiological changes in the diaphyseal bone density (DEXA BMD progression over time in all Gruen Zones (Zone 1-7)	preoperative, at discharge (1 week postop) and 12 months postoperative

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Henning Windhagen, Prof. Dr., Orthopädische Kliniken im Annastift, MHH

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; DEXA Bone Density Analysis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Rheumatic Diseases; Necrosis; Osteoarthritis; Osteonecrosis; Pathological Conditions, Signs and Symptoms; Arthritis; Wounds and Injuries; Osteoarthritis, Hip; Femur Head Necrosis
• Other Study ID Numbers: AAG-G-H-23009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No