Back to resultsA Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Primary Purpose
Osteoarthritis, Hip
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GTS cementless stem
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
GTS cementless stem
Arm Description
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
Outcomes
Primary Outcome Measures
Mean Harris Hip score
Harris Hip Score tests will be carried out pre-operatively and at each follow-up period to assess pain, function, mobility and range of motion.
Secondary Outcome Measures
Stability, incidence of radiolucencies around the prosthesis and bone remodeling
standardized full pelvic anteroposterior (AP) Xray and a lateral X-ray taken at immediate postoperative and 1, 3, 5 and 10 years post-operative follow-up visits, and optionally at 3 months, 2, and 7 years after surgery.
Patient satisfaction
EQ5D quality of life score will be taken at every follow-up clinic and by postal questionnaire when patients are not attending a clinic.
Adverse Events/Complications
Including revisions/removals
Survivorship
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02851992
Brief Title
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Official Title
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2012 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
September 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GTS cementless stem
Arm Type
Other
Arm Description
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
Intervention Type
Device
Intervention Name(s)
GTS cementless stem
Intervention Description
Total Hip Arthroplasty
Primary Outcome Measure Information:
Title
Mean Harris Hip score
Description
Harris Hip Score tests will be carried out pre-operatively and at each follow-up period to assess pain, function, mobility and range of motion.
Time Frame
2 years post-operative
Secondary Outcome Measure Information:
Title
Stability, incidence of radiolucencies around the prosthesis and bone remodeling
Description
standardized full pelvic anteroposterior (AP) Xray and a lateral X-ray taken at immediate postoperative and 1, 3, 5 and 10 years post-operative follow-up visits, and optionally at 3 months, 2, and 7 years after surgery.
Time Frame
until 10 years post-operatively
Title
Patient satisfaction
Description
EQ5D quality of life score will be taken at every follow-up clinic and by postal questionnaire when patients are not attending a clinic.
Time Frame
until 10 years post-operatively
Title
Adverse Events/Complications
Description
Including revisions/removals
Time Frame
until 10 years post-operatively
Title
Survivorship
Time Frame
until 10 years post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
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