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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTS cementless stem | Other | Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTS cementless stem | Device | Total Hip Arthroplasty |
|
| 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 |
| 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 |
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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
Additional inclusion criteria include:
Exclusion Criteria:
Exclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem
Absolute contraindications include:
Additional exclusion criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
303 patients were enrolled in the study, 22 were excluded due to receiving a different device (20) or a screen failure (2), and therefore also not included in the baseline demographic analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | pre-operatively and 2 years post-operatively |
|
up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other hip related, Cupule conflict /psoas, cup too wide | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Withdrawn, Conflict with The Patient / Trial / Stop of Follow-Up | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisette Smid, Clinical Project Lead | Zimmer Biomet | +31 62 395 6378 | lisette.smid@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2012 | May 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
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 |
|
|
| 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. | per-protocol population (all participants with 1 year radiographic evaluation available) | Posted | Count of Participants | Participants | 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. | per-protocol population (number of subjects who completed the questionnaire were included in the analysis) | Posted | Mean | Standard Deviation | score on a scale | pre-operatively and 2 years post-operatively |
|
|
|
| Secondary | Adverse Events/Complications | The number of revisions/removals, device-related SAE's and deaths are listed. | Complications up to 2 years post-op | Posted | Count of Participants | Participants | 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. | per-protocol population | Posted | Count of Participants | Participants | at 2 years post-op |
|
|
|
| 0 |
| 281 |
| 11 |
| 281 |
| 32 |
| 281 |
| Fall of patient resulting in revision | Injury, poisoning and procedural complications | Systematic Assessment | Revision of the stem |
|
| Dislocation, 2/ DISLOCATION ON 06/26/15 | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other hip related, psoas tendonitis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Acetabular implant failure | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other hip related, left iliac fracture due to fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dislocation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Femoral implant failure and fracture of femoral shaft | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other general complication and Thrombophlebitis of the calf | General disorders | Systematic Assessment |
|
| Other general complication | General disorders | Systematic Assessment |
|
| Revision of cup & liner due to instability | Injury, poisoning and procedural complications | Systematic Assessment | Revision of cup&liner |
|
| Instability | Injury, poisoning and procedural complications | Systematic Assessment |
|
| LTF | Social circumstances | Systematic Assessment |
|
| Withdrawn, not willing to return | Social circumstances | Systematic Assessment |
|
| Other hip related, bursitis trochanterica | General disorders | Systematic Assessment |
|
| Dislocation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other hip related, the patient doesn't execute functional kine | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fracture of femoral neck | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Haemorrhage | Cardiac disorders | Systematic Assessment | linked to an overdose of anticoagulant, slower and long rehabilitation but no consequences |
|
| Other general complication, results and scores affected by knee pathology | General disorders | Systematic Assessment |
|
| Femoral implant fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other general complication, total hip replacement | General disorders | Systematic Assessment |
|
| Other general complication, total knee replacement | General disorders | Systematic Assessment |
|
| Other general complication, Gastroesophageal reflux disease | General disorders | Systematic Assessment |
|
| Superficial infection | Infections and infestations | Systematic Assessment |
|
| Nerve injury, dropfoot left | Nervous system disorders | Systematic Assessment |
|
| Other general complication, coxarthrosis contralateral hip | General disorders | Systematic Assessment |
|
| Other general complication, coxarthrosis contralateral | General disorders | Systematic Assessment |
|
| Other general complications | General disorders | Systematic Assessment |
|
| Nerve injury, paralysis of the extra popliteal sciatic nerve | Nervous system disorders | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
|
| Calcar resorption (1y) |
|
|
| Heterotopic ossification (1y) |
|
|
|
| Title |
|---|
| Measurements |
|---|
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