Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System (NCT02154516) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System
South Africa26 participantsStarted 2011-11-04
Plain-language summary
The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.
Who can participate
Age range
21 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:
* At least 21 years old
* Skeletally mature
* Requires primary, unilateral total hip arthroplasty due to degenerative join disease
* Preoperative Harris Hip Score of less than or equal to 70
* Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk
* Given consent to participate in the study
* Able to understand the purpose of the study, his/her role, and is available for follow-up
10 year extension:
* Subject has completed the 2 year primary study
* Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form
* Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up
Exclusion Criteria:
* Diagnosis with high risk of Total Hip Arthroplasty (THA) failure
* Requires bilateral THA
* Requires revision of a prior hip replacement
* Active infection or sepsis
* History of local hip infection
* Known metastatic or neoplastic disease
* Conditions that may interfere with THA survival or outcomes
* Need for structural bone grafts to support the implant
* Contralateral lower extremity condition
* Has other joint replacements or plans for other joint replacements within 2 years
* Systemic …
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
Number of Participants With Device-Related Revisions
Timeframe: Postoperatively through 10 years
2
Metal Ion Concentration in Whole Blood
Timeframe: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.