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Terminated
NCT02851992
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Conditions: Osteoarthritis, Hip
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 303
Sponsor: Zimmer Biomet
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT02851992). StuddyBuddy aggregates publicly available trial information.