A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem (NCT02851992) | Clinical Trial Compass
TerminatedNot Applicable
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Stopped: Zimmer Biomet is prioritizing specific products within its portfolio and has chosen not to extend the CE mark for the GTS stem under MDR requirements, leading to the premature termination of the GTS study in 2024.
303 participantsStarted 2012-09
Plain-language summary
This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.
Who can participate
Age range
18 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 inclusion criteria for this evaluation are be in accordance with the indications of the GTS® stem and specifically
* Primary osteoarthritis or secondary coxarthritis
* Inflammation of the hip: rheumatoid arthritis, etc.
* Femoral neck fracture
* Avascular necroses of the femoral head
* Sequelae from previous operations on the hip, osteotomies, etc.
* Congenital hip dysplasia
Additional inclusion criteria include:
* 18 years of age or older
* Subjects willing to return for follow-up evaluations
* Subjects who read, understood study information and provided an informed written consent (specific local regulatory requirements)
Exclusion Criteria:
Exclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem
Absolute contraindications include:
* Local or systemic infections.
* Severe muscular, neurological or vascular deficiencies of the extremity involved
* Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.)
* Concomitant disease likely to affect implant function
* Allergy to any of the components of the implant
* Patients weighing more than 110 kg
Additional exclusion criteria:
* Subjects unable to co-operate with and complete the study
* Dementia and/or inability to understand and follow instructions
* Neurological conditions affecting movement
* Patient over 18 under law supervision
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
Mean Harris Hip Score
Timeframe: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.