Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06632301

DEXA Bone Density Analysis of the CoreHip® Prosthesis System

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Primary Osteoarthritis Arthritis Bone Diseases Cartilage Degeneration Femur Head Necrosis Inflammatory Arthritis Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteoarthritis, Hip Osteonecrosis Osteonecrosis of Femoral Head Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Traumatic Disorder Wounds and Injuries

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location contact

Henning Windhagen

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary hip replacement with cementless stem

Device

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

Primary outcomes

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

    Time frame: within 24 months postoperative

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

Secondary outcomes

  1. Clinical Results: Joint Function (Harris Hip Score)

    Time frame: 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.

  2. Development of Quality of Life (EQ-5D-5L)

    Time frame: 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.

  3. Development of Forgotten Joint Score

    Time frame: 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.

  4. Development of Pain

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

    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].

  5. Development of Pain

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Kerstin Bergmann

CONTACT

[email protected]

+49746195

Stefan Maenz

CONTACT

[email protected]

0746195

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: CODEX

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Oct 9, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.