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NCT06632301 | NOT YET RECRUITING | Primary Osteoarthritis

DEXA Bone Density Analysis of the CoreHip® Prosthesis System
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.

Condition or disease

Primary Osteoarthritis

Cartilage Degeneration

Osteoarthritis, Hip

Inflammatory Arthritis

Osteonecrosis of Femoral Head

Traumatic Disorder

Intervention/treatment

Primary hip replacement with cementless stem

Phase

NA

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
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : DEXA Bone Density Analysis to Analyze the Loading Concept of the CoreHip® Prosthesis
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
DEXA Bone Density Analysis of the CoreHip® Prosthesis System

Location Details

NCT06632301

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How to Participate

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Locations

Not yet recruiting

Germany,

Medical University of Hanover

Hannover, Germany, 30625