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

Zimmer Biomet

Status: Active, not recruiting

Conditions: Osteoarthritis, Hip

Treatments: Device: GTS cementless stem

Study type: Interventional

Funder types: Industry

Identifiers

NCT02851992

ORTHO.CR.H36

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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303 participants in 1 patient group

GTS cementless stem

Other group

Description:

Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)

Treatment:

Device: GTS cementless stem