DEXA Bone Density Analysis of the CoreHip® Prosthesis System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-85
SponsorAesculap AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unilateral hip osteoarthritis

Indication for CoreHip Standard hip stem according to preoperative planning

Written Informed Consent

Age 35-85 years

Disqualifiers

Femoral neck fractures

Pregnancy

BMI > 35

History of femoral fracture or previous surgery on the same hip

Trial design

Design model

Single group

Treatments tested in this trial

  • Primary hip replacement with cementless stem

    Device

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: DEXAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
within 24 months postoperative

Secondary outcomes

1

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.

Time frame
preoperative, at discharge (1 week postop) and 12 months postoperative
2

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.

Time frame
preoperative, at discharge (1 week postop) and 12 months postoperative
3

Development of Forgotten Joint Score

The EQ-5D-5L score is a generic score used to document the well-being of the patient.

Time frame
preoperative, at discharge (1 week postop) and 12 months postoperative
4

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 \[on 100-mm scale\].

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: