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New treatment option for Total Hip Arthroplasty
Official title Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT06287021
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Patient candidated to undergo unilateral cementless primary total hip arthroplasty with Jump System Traser® cup or Jump System HAX-Pore® cup by...
- Patient with primary or secondary hip osteoarthritis;
- Patient who has given informed consent;
You likely can't join if
- 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...
See the full eligibility 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;
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.