DEXA Bone Density Analysis of the CoreHip® Prosthesis System

NCT06632301 | Not Yet Recruiting

• 1 other identifier: AAG-G-H-23009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Total Hip Arthroplasty; DEXA Bone Density Analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinical Results: Joint Function (Harris Hip Score)

  preoperative, at discharge (1 week postop) and 12 months postoperative

• Development of Quality of Life (EQ-5D-5L)

  preoperative, at discharge (1 week postop) and 12 months postoperative

• Development of Forgotten Joint Score

  preoperative, at discharge (1 week postop) and 12 months postoperative

• Development of Pain

  preoperative, at discharge (1 week postop) and 12 months postoperative

• Development of Pain

  preoperative, at discharge (1 week postop) and 12 months postoperative

Study Arms (1)

DEXA

EXPERIMENTAL

DEXA bone density analysis to analyze the loading concept of the CoreHip® Prosthesis System

Device: Primary hip replacement with cementless stem

Interventions

Primary hip replacement with cementless stem DEVICE

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

DEXA

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis; Femur Head Necrosis; Wounds and Injuries

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henning Windhagen, Prof. Dr.

  Orthopädische Kliniken im Annastift, MHH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerstin Bergmann

CONTACT

+49746195; info@aesculap.de

Stefan Maenz

CONTACT

0746195; info@aesculap.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

DE (1)