Exception Cementless Hip Stem (NCT04349046) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Exception Cementless Hip Stem
Belgium, France332 participantsStarted 2021-01-01
Plain-language summary
This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.
Who can participate
Age range
18 Years – 100 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.
At the time of surgery, the inclusion criteria were based on the indications presented in the IFUs:
* Primary or secondary osteoarthritis
* Inflammatory impairment of the hip, rheumatoid arthritis, etc.
* Fracture of the neck of the femur
* Avascular necrosis of the femoral head
* Sequelae from previous operations on the hip, osteotomies, etc.
* Congenital hip dysplasia.
* Patient is older than 18 years old
* Patient had consented to the original data collection after his/her surgery
At the time of surgery, the exclusion criteria were based on the contraindications presented in the IFUs:
* Local or systemic infections.
* Serious muscular, neurological or vascular deficiencies in the limb concerned.
* Bone destruction or poor quality bone likely to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
* Any concomitant disorder likely to affect the function of the implant.
* Allergy to one of the implant components.
* Patients weighing more than 110 kg.
* Patient incapable of following the recommendations of the surgeon
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
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method