Osteoarthritis, Hip Clinical Trial
Official title:
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Verified date | November 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 303 |
Est. completion date | September 2028 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Adverse Events/Complications | The number of revisions/removals, device-related SAE's and deaths are listed. | until 2 years post-operatively | |
Secondary | 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 |
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