This trial is active, not recruiting.

Condition osteoarthritis, hip
Treatment gts cementless stem
Sponsor Biomet, Inc.
Start date September 2012
End date September 2017
Trial size 250 participants
Trial identifier NCT02851992, ORTHO.CR.H36


This is a multicenter, non-controlled, prospective study. 250 subjects (GTS standard and lateralized) will be recruited. Study will be conducted in centers across Europe.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
gts cementless stem
Total Hip Arthroplasty

Primary Outcomes

Mean Harris Hip score
time frame: 2 years post-operative

Secondary Outcomes

Stability, incidence of radiolucencies around the prosthesis and bone remodeling
time frame: until 10 years post-operatively
Patient satisfaction
time frame: until 10 years post-operatively
Adverse Events/Complications
time frame: until 10 years post-operatively
time frame: until 10 years post-operatively

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..