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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02851992). StuddyBuddy aggregates publicly available trial information.