Osteoarthritis, Hip
Conditions
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.
Interventions
DEVICEGTS cementless stem
Total Hip Arthroplasty
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Harris Hip Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling | 10 years post-surgery. | 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. |
| Patient Satisfaction | Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-surgery | 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. |
| Adverse Events/Complications | From surgery through the 10-year post-operative follow-up period. | The number of revisions/removals, SAE's and deaths are listed. |
| Revision-Free Survivorship Through 10 Years | From implantation through 10 years post-operatively | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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)
GTS cementless stem: Total Hip Arthroplasty | 281 |
| Total | 281 |
Baseline characteristics
| Characteristic | GTS Cementless Stem |
|---|---|
| Age, Continuous | 62.98 years STANDARD_DEVIATION 11.76 |
| Diagnosis congenital dysplasia | 16 Participants |
| Diagnosis Femoral neck fracture | 3 Participants |
| Diagnosis Inflammatory joint disease | 8 Participants |
| Diagnosis Osteonecrosis of the femoral neck | 18 Participants |
| Diagnosis other | 6 Participants |
| Diagnosis Post-traumatic arthritis | 5 Participants |
| Diagnosis Primary Osteoarthritis | 225 Participants |
| Region of Enrollment France | 50 Participants |
| Region of Enrollment Germany | 94 Participants |
| Region of Enrollment Italy | 40 Participants |
| Region of Enrollment Netherlands | 22 Participants |
| Region of Enrollment Spain | 75 Participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 281 |
| other Total, other adverse events | 11 / 281 |
| serious Total, serious adverse events | 12 / 281 |
Outcome results
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.
Time frame: pre-operatively and 2 years post-operatively
Population: The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a maximum of 100 points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GTS Cementless Stem | Mean Harris Hip Score | 2 year post-operatively | 97.75 Units on a scale | Standard Deviation 6.5 |
| GTS Cementless Stem | Mean Harris Hip Score | pre-operatively | 50.36 Units on a scale | Standard Deviation 15.93 |
Secondary
Adverse Events/Complications
The number of revisions/removals, device-related SAE's and deaths are listed.
Time frame: until 2 years post-operatively
Population: Complications up to 2 years post-op
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GTS Cementless Stem | Adverse Events/Complications | Revision | 3 Participants |
| GTS Cementless Stem | Adverse Events/Complications | device-related SAE | 2 Participants |
| GTS Cementless Stem | Adverse Events/Complications | death | 0 Participants |
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.
Time frame: pre-operatively and 2 years post-operatively
Population: per-protocol population (number of subjects who completed the questionnaire were included in the analysis)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GTS Cementless Stem | Patient Satisfaction | pre-operatively | 0.41 score on a scale | Standard Deviation 0.29 |
| GTS Cementless Stem | Patient Satisfaction | 2 years post-operatively | 0.96 score on a scale | Standard Deviation 0.15 |
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.
Time frame: 1 year post-operatively
Population: per-protocol population (all participants with 1 year radiographic evaluation available)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GTS Cementless Stem | Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling | Subsidence of the stem (1y) | 13 Participants |
| GTS Cementless Stem | Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling | stem radiolucencies (1y) | 4 Participants |
| GTS Cementless Stem | Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling | Calcar resorption (1y) | 3 Participants |
| GTS Cementless Stem | Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling | Heterotopic ossification (1y) | 8 Participants |
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.
Time frame: at 2 years post-op
Population: per-protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GTS Cementless Stem | Survivorship | 278 Participants |