A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem

A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem

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.

The objective of this prospective clinical study is to obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem in its standard and lateralized versions as part of Post Market Surveillance requirements.

The initial study assessment period will be 12 years; 24 months recruitment and the follow-up clinical reviews for all patients will be at 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

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