Health TrialsbyHealthPanel

Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

ConditionTotal Hip Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorPermedica spa

About this trial

The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient candidated to undergo unilateral cementless primary total hip arthroplasty with Jump System Traser® cup or Jump System HAX-Pore® cup by Permedica Orthopaedics (study sponsor).

Patient with primary or secondary hip osteoarthritis;

Patient who has given informed consent;

Disqualifiers

Male patients younger than 40 years or older than 85 years;

Female patients younger than 50 years or older than 85 years;

Childbearing;

Patients not indicated for receiving the investigational devices;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Jump System Traser® cup

    Device

    Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup

  • Jump System HAX-Pore® cup

    Device

    Press-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Jump System Traser® cupExperimental treatment 1 intervention
Group B: Jump System HAX-Pore® cupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

BMD - ROI 1

Periprosthetic BMD (bone mineral density) measured by DEXA in ROI (region of interest) 1 (above the acetabular cup)

Time frame
Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up

Secondary outcomes

1

BMD - ROI 2,3,4

Periprosthetic BMD (bone mineral density) measured by DEXA in ROI (region of interest) 2, 3 and 4 (behind and below the acetabular cup)

Time frame
Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
2

Harris hip score

Clinical score for hips undergoing total hip arthroplasty. The Harris hip score ranges from 0 to 100, where 100 indicates the best outcome possible for the patient.

Time frame
Preoperative,12-month, and 24-month follow-up
3

Moore's osseointegration signs

Five radiographic signs around the acetabular cup revealing the stability and osseointegration status of cementless component: (1) absence of radiolucent lines; (2) presence of a superolateral buttress; (3) medial stress-shielding; (4) radial trabeculae; and (5) an inferomedial buttress. The presence of 3 to 5 signs visible on anterior-posterior radiograph of the hip indicates 97% probability of a well osseointegrated cup. The presence of 1 or no signs indicates 83% probability of unstable, not osseointegrated cup.

Time frame
12-month and 24-month follow-up

Other outcomes

Sponsors and contacts

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

Permedica spa

Lead sponsor

Source ClinicalTrials.gov
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