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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: GTS cementless stem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GTS cementless stem<br>Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene) | Device: GTS cementless stem<br>* Total Hip Arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pre-operatively and 2 years post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling | The presence or absence of the following femoral radiographic findings were reported: subsidence of the stem, stem radiolucencies, calcar resorption, heterotopic ossification. | 1 year post-operatively | 
| 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. | pre-operatively and 2 years post-operatively | 
| Adverse Events/Complications | The number of revisions/removals, device-related SAE's and deaths are listed. | until 2 years post-operatively | 
| Survivorship | Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 2 years post-operative is presented here. | at 2 years post-op |