Survival of 11,390 Continuum cups in primary total hip arthroplasty based on data from the Finnish Arthroplasty Register.
Matias Hemmilä, Mikko Karvonen, Inari Laaksonen...
https://pubmed.ncbi.nlm.nih.gov/30994043Actively Recruiting
Phase Not Applicable
Age: 40Years - 85Years
All Genders
Healthy Volunteers
ID06287021
Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty
Led by Permedica spa · Updated on 2025-09-02
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the changes in bone mineral density around two types of acetabular cups used in primary total hip arthroplasty. The study compares a 3D-printed highly-porous trabecular titanium cup with a standard hydroxyapatite/titanium plasma-sprayed cup. It focuses on how bone remodeling occurs up to two years after surgery to understand differences in implant integration and longevity. Participants will be randomly assigned to receive either the investigational Jump System Traser ae cup, a press-fit, cementless 3D-printed highly-porous titanium device, or the control Jump System HAX-Pore ae cup, a press-fit, cementless hydroxyapatite/titanium plasma-sprayed cup. Both cups have the same design, and treatments are administered during unilateral primary total hip arthroplasty. The study will follow patients for two years, with bone density measured at multiple time points. Patients will undergo DEXA scans before discharge and at 1 week, 3 months, 6 months, 12 months, and 24 months after surgery to measure bone mineral density in four regions around the cup. Researchers will also assess clinical outcomes using the Harris hip score and look for signs of osseointegration at 12 and 24 months. The trial involves detailed monitoring of bone remodeling and implant integration during the two-year follow-up period.
CONDITIONS
Brief Title
Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
Who Can Participate
Age: 40Years - 85Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patient scheduled for unilateral cementless primary total hip arthroplasty with Jump System Traser�ae cup or Jump System HAX-Pore�ae cup
- Diagnosis of primary or secondary hip osteoarthritis
- Provided informed consent to participate
You will not qualify if you...
- Male patients younger than 40 years or older than 85 years
- Female patients younger than 50 years or older than 85 years
- Women who are pregnant or of childbearing potential
- Not indicated for the investigational devices
- Not indicated for cementless metaphyseal short femoral stems branded Exacta RS or Exacta S
- Rheumatoid arthritis, avascular osteonecrosis, severe hip dysplasia (Crowe grade III-IV), Perthes disease, Paget disease
- Femoral neck fracture, pelvic fracture, or prior surgery/trauma sequelae to the same hip
- Bone disorders
- Diabetes
- Receiving parathyroid hormone, corticosteroid, or osteoporosis treatment
- Disabling disease in the opposite limb
- Body mass index (BMI) over 30 or under 18
- Unwilling or unable to follow the study protocol
- Addiction to alcohol or drugs
- Currently enrolled in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and hospital stay until discharge
Participants undergo unilateral primary total hip arthroplasty with either the highly-porous trabecular titanium cup or the hydroxyapatite/titanium plasma-sprayed cup.
1 surgical visit and hospital stay
Post-operative Follow-up
Duration - Up to 24 months
Participants are followed after surgery to monitor bone remodeling around the acetabular cup and assess clinical and radiological outcomes.
DEXA scans and clinical assessments at 1 week postoperatively, 3 months, 6 months, 12 months, and 24 months; Harris hip score and osseointegration signs assessments at 12 and 24 months
Trial Site Locations
Total: 2 locations
1
IRCCS Istituto Clinico San Siro
Milan, Italy, 20148
Actively Recruiting
2
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy, 20161
Actively Recruiting
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Research Team
L
Lorenzo Banci, MSc
M
Marta Colombo, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Meta-analysis of individual registry results enhances international registry collaboration.
Elizabeth W Paxton, Maziar Mohaddes, Inari Laaksonen...
https://pubmed.ncbi.nlm.nih.gov/29589467Trabecular metal acetabular components in primary total hip arthroplasty.
Inari Laaksonen, Michelle Lorimer, Kirill Gromov...
https://pubmed.ncbi.nlm.nih.gov/29400118Survivorship of a Porous Tantalum Monoblock Acetabular Component in Primary Hip Arthroplasty With a Mean Follow-Up of 18 Years.
George A Macheras, Panagiotis Lepetsos, Andreas O Leonidou...
https://pubmed.ncbi.nlm.nih.gov/28734611Comparative analysis of osseointegration in various types of acetabular implant materials.
Stanislav Bondarenko, Ninel Dedukh, Volodymyr Filipenko...
https://pubmed.ncbi.nlm.nih.gov/29742946Periacetabular bone densitometry after total hip arthroplasty with highly porous titanium cups: a 2-year follow-up prospective study.
Leo Massari, Alessandro Bistolfi, Pier Paolo Grillo...
https://pubmed.ncbi.nlm.nih.gov/28708200Porous titanium construct cup compared to porous coated titanium cup in total hip arthroplasty. A randomised controlled trial.
Mats Salemyr, Olle Muren, Thomas Eisler...
https://pubmed.ncbi.nlm.nih.gov/25338110Bone loss around a stable, partly threaded hydroxyapatite-coated cup: a prospective cohort study using RSA and DXA.
Stergios Lazarinis, Jan Milbrink, Per Mattsson...
https://pubmed.ncbi.nlm.nih.gov/24500826A randomised study of peri-prosthetic bone density after cemented versus trabecular fixation of a polyethylene acetabular component.
K Periasamy, W S Watson, A Mohammed...
https://pubmed.ncbi.nlm.nih.gov/21768625Comparison of trabecular metal cups and titanium fiber-mesh cups in primary hip arthroplasty: a randomized RSA and bone mineral densitometry study of 50 hips.
Thomas Baad-Hansen, Søren Kold, Poul Torben Nielsen...
https://pubmed.ncbi.nlm.nih.gov/21434845