Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®) (NCT03113981) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
France340 participantsStarted 2017-05-08
Plain-language summary
The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment.
The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis.
Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis.
A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion and increase biocompatibility and bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting.
No previous clinical trial
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged over 50 and under 75 years OR aged under 50 years with joint lesions not amenable to successful conservative treatment.
* THA following a primary or secondary osteoarthritis
* THA following an aseptic osteonecrosis
* THA following a rapidly destructive osteoarthritis
* Social insurance
* Informed and signed consent
Exclusion Criteria:
* Patients younger than 50 years and with joint lesions that can be successfully treated with conservative treatment
* Inflammatory rheumatism
* Long-term corticosteroid treatment
* Tumor Pathology of the hip bone
* Study femoral stem not adapted to the patient's anatomy (verified on preoperative X-rays using Ceraver templates).
* Loss of bone of the joint that makes it impossible to properly anchor a cementless prosthesis
* Acetabular or femoral bone graft associated
* Infectious hip arthritis history
* Evolving infection of the articulation or peri-articular region involved, including severe neuroarthropathy
* Surgical history on the affected hip
* Allergy known to any component of prostheses
* Known hypersensitivity to polystyrene sulfonate resins
* Native cotyl with a diameter of less than 42mm or greater than 68mm
* Significant muscle loss, neuromuscular injury or vascular insufficiency of affected limb
* Charcot's disease
* Immunocompromised patients
* Difficulties of follow-up (departure on vacation, imminent change, geographical distance, patients not residing in metropolis, insufficient motivation)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Osseous-integration of the femoral stem and the acetabular component