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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
303
Total Hip Arthroplasty
Mean Harris Hip Score
Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.
Time frame: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
The presence or absence of the following femoral radiographic findings was assessed at the 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years post-surgery follow-up visit: subsidence of the stem, stem radiolucencies, calcar resorption, and heterotopic ossification.
Time frame: 10 years post-surgery.
Patient Satisfaction
EQ-5D quality of life score will be taken at every follow-up clinic and by postal questionnaire when patients are not attending a clinic. The EQ-5D is a standardized instrument widely used to measure health status. The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. Scores will be within the range of 0-1 with 1 corresponding to perfect health.
Time frame: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-surgery
Adverse Events/Complications
The number of revisions/removals, SAE's and deaths are listed.
Time frame: From surgery through the 10-year post-operative follow-up period.
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Revision-Free Survivorship Through 10 Years
Revision-free survivorship was defined as the number of participants who did not undergo revision or removal of any hip implant component from implantation through the 10-year post-operative follow-up period.
Time frame: From implantation through 10 years post-operatively