Primary OsteoarthritisCODEXNCT06632301
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
A study testing Primary hip replacement with cementless stem in people with Primary Osteoarthritis and Cartilage Degeneration, run by Aesculap AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Primary Osteoarthritis, Cartilage Degeneration, Osteoarthritis, Hip
- What is being tested?
- Primary hip replacement with cementless stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2026to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Medizinische Hochschule Hannover
Hanover, 30625
Henning Windhagen
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Osteoarthritis, Cartilage Degeneration, Osteoarthritis, Hip, Inflammatory Arthritis, Osteonecrosis of Femoral Head, Traumatic Disorder
- Being tested
- Primary hip replacement with cementless stem
- Keywords
- Total Hip Arthroplasty, DEXA Bone Density Analysis
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Femur Head Necrosis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary hip replacement with cementless stemDevice
Total Hip Arthroplasty is today one of the most established surgical orthopaedic procedures worldwide.
| Study group | Role | What they receive |
|---|---|---|
| DEXA | Experimental | DEXA bone density analysis to analyze the loading concept of the CoreHip® Prosthesis System Receives: Device: Primary hip replacement with cementless stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4)
Changes in bone mineral density (BMD) according to Gruen.
Measured: within 24 months postoperative
Secondary outcomes (5)
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.
Measured: 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.
Measured: preoperative, at discharge (1 week postop) and 12 months postoperative
Development of Forgotten Joint Score
A joint-specific questionnaire with the aim to measure PRO of joint disorders . FJS is designed to measure the ability of the patient to "forget" about their problematic joint after treatment
Measured: 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].
Measured: 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)
Measured: preoperative, at discharge (1 week postop) and 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study startDec 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning Windhagen, Prof. Dr., Principal investigator, Orthopädische Kliniken im Annastift, MHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632301
- Sponsor's protocol ID
- AAG-G-H-23009
- Acronym
- CODEX
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No