A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Zimmer Biomet
- Enrollment
- 303
- Primary Endpoint
- Mean Harris Hip Score
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
GTS cementless stem
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
Intervention: GTS cementless stem (Device)
Outcomes
Primary Outcomes
Mean Harris Hip Score
Time Frame: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.
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.
Secondary Outcomes
- Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling(10 years post-surgery.)
- Patient Satisfaction(Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-surgery)
- Adverse Events/Complications(From surgery through the 10-year post-operative follow-up period.)
- Revision-Free Survivorship Through 10 Years(From implantation through 10 years post-operatively)