Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

April 2, 2024 updated by: Permedica spa

Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In joint arthroplasty, the need to use devices with highly-porous structures even more close to cancellous bone, arises from the need of optimal implant primary stability and osseointegration to guarantee long term longevity of the prosthetic implant.

After decades of clinical use of highly-porous tantalum (Trabecular Metal) acetabular components in total hip arthroplasty with excellent results, new highly-porous titanium structures have been developed and introduced in the market thanks to the additive manufacturing technology.

This study aims to investigate how bone remodeling occurs after primary total hip arthroplasty around a highly-porous trabecular-irregular acetabular cup, 3D-printed with selective laser melting, in comparison with a standard hydroxyapatite/titanium plasma-sprayed cup with the same design. The null hypothesis, which the study aims to reject, is that there is no difference in bone mineral density changes between highly-porous and traditional plasma-sprayed cups.

Overall 50 patients will be enrolled to be 1:1 randomized for receiving the investigational cup or the control cup in two centers.

Periprosthetic bone mineral density will be measured by DEXA (Dual-Energy X-ray Absorptiometry) around the acetabular cup according to four ROI (Region Of Interest). DEXA scans will be taken at different time-points up to 2-year follow-up. DEXA scan taken before patient discharge will be used as baseline.

Patients will be assessed also for clinical and radiological results, with focus on osseointegration signs of the acetabular cup.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20148
      • Milan, Italy, 20161
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio
        • Contact:
        • Contact:
          • Laura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • Patients not indicated for receiving cementless metaphyseal short femoral stems by Permedica Orthopaedics as the "Exacta RS" or "Exacta S" brand;
  • Patients with rheumatoid arthritis, avascular osteonecrosis, severe hip dysplasia (grade III-IV according to Crowe classification), Perthes disease, Paget disease, femoral neck fracture, pelvic fracture or sequelae of previous surgical procedures or trauma to the ipsilateral hip;
  • Patients with bone disorders;
  • Patients with diabetes;
  • Patients under PTH (parathyroid hormone), corticosteroid, or osteoporosis pharmacological therapy;
  • Patients with disabling disease in the contralateral limb;
  • Patients with BMI > 30 or < 18;
  • Patients not willing to follow the study protocol;
  • Patients incapable to understand the study protocol;
  • Patients addicted to alcohol or drugs;
  • Patients already enrolled in other clinical investigations;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jump System Traser® cup
25 patients receiving unilateral primary total hip arthroplasty with the Jump System Traser® acetabular cup, a 3D-printed highly-porous titanium cup
Device: Jump System Traser® cup
Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup
Active Comparator: Jump System HAX-Pore® cup
25 patients receiving unilateral primary total hip arthroplasty with the Jump System HAX-Pore® acetabular cup, a standard hydroxyapatite/titanium plasma-sprayed cup
Device: Jump System HAX-Pore® cup
Press-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMD - ROI 1
Time Frame: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
Periprosthetic BMD (bone mineral density) measured by DEXA in ROI (region of interest) 1 (above the acetabular cup)
Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMD - ROI 2,3,4
Time Frame: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
Periprosthetic BMD (bone mineral density) measured by DEXA in ROI (region of interest) 2, 3 and 4 (behind and below the acetabular cup)
Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
Harris hip score
Time Frame: Preoperative,12-month, and 24-month follow-up
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.
Preoperative,12-month, and 24-month follow-up
Moore's osseointegration signs
Time Frame: 12-month and 24-month follow-up

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.
12-month and 24-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Permedica spa

Investigators

  • Study Director: Lorenzo Banci, MSc, Permedica Orthopaedics, Merate, Italy
  • Principal Investigator: Giuseppe Peretti, MD, IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy
  • Principal Investigator: Paolo Sirtori, MD, Istituto Clinico San Siro, Milan, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRASERBMD2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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