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Stafit Acetabular System not CE marked anymore
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This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.
The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records.
Data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty.
The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients who received the Stafit Acetabular System | Device | Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival | Represents the implants that survived by counting the number of implants revised. | 3 years postoperatively, due to early study termination |
| Dislocation Rate | Assessed by counting the number of implant dislocations | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Pain and Functional Performance Determined by the Harris Hip Score | The Harris Hip Score is a questionnaire filled by the surgeon on the patients who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stairs, public transportation, sitting, and managing shoes and socks) and gait (limp, support needed for walking, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a minimum of 0 (worst possible score) to a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Paola Vivoda | Zimmer Biomet | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Who Received the Stafit Acetabular System | Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Who Received the Stafit Acetabular System | Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria. |
| 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 | Implant Survival | Represents the implants that survived by counting the number of implants revised. | Outcome Measure Data at 3 years postoperative (Study early terminated). The Kaplan-Meier survival rate with cup revision for any reason. | Posted | Number | percentage of implant survival | 3 years postoperatively, due to early study termination | Implants | Implants |
|
|
follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively.
List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
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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 | Patients Who Received the Stafit Acetabular System | Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral Implant Fracture | Surgical and medical procedures | Systematic Assessment | Treated by change of the Stem |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Infection <6 Weeks | Infections and infestations | Systematic Assessment | Treated by lavage and antibiotic |
Early study termination leading less patients enrolled and shorter follow-up as initially planned in the study protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emilie Rohmer, Clinical Operations Manager | Zimmer Biomet | +41 58 85 48210 | Emilie.Rohmer@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 | Nov 14, 2011 | May 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D006620 | Hip Fractures |
| D006617 | Hip Dislocation |
| D010020 | Osteonecrosis |
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 3 years postoperatively, due to early study termination |
| Confirmation of Safety Based on Complications | Reported number of patients with adverse events related to the implant. Adverse events include: dislocations of the hip, revisions and removals of the implants | 3 years postoperatively, due to early study termination |
| 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 |
|
| Body Mass Index (kg/m2) | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
| Implants |
|
|
| Primary | Dislocation Rate | Assessed by counting the number of implant dislocations | Count of the number of dislocations 2 years postoperatively. | Posted | Number | Implant Dislocations | 2 years | implants | implants |
|
|
|
| Secondary | Evaluation of Pain and Functional Performance Determined by the Harris Hip Score | The Harris Hip Score is a questionnaire filled by the surgeon on the patients who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stairs, public transportation, sitting, and managing shoes and socks) and gait (limp, support needed for walking, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a minimum of 0 (worst possible score) to a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). | Outcome Measure Data at 3 years postoperative (Study early terminated). Number Of Unilateral Participants: 48 Unilaterals; Number Of Bilateral Participants : 1 | Posted | Mean | Standard Deviation | score on a scale | 3 years postoperatively, due to early study termination | Implants | Implants |
|
|
|
| Secondary | Confirmation of Safety Based on Complications | Reported number of patients with adverse events related to the implant. Adverse events include: dislocations of the hip, revisions and removals of the implants | Outcome Measure Data at 3 years postoperative (Study early terminated). Record of any adverse events related to the Stafit Acetabular System. | Posted | Number | study patients | 3 years postoperatively, due to early study termination |
|
|
|
| 6 |
| 166 |
| 10 |
| 166 |
| 11 |
| 166 |
|
| Death (Stroke) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment | Treated by lavage and antibiotic. |
|
| Deep Infection <6 Weeks | Infections and infestations | Systematic Assessment | Treated by lavage and antibiotic. |
|
| Infection | Infections and infestations | Systematic Assessment | Treated by 2 Red cell transfusion |
|
|
| Stroke | Blood and lymphatic system disorders | Systematic Assessment |
|
| Peroperative fracture of the femur | Surgical and medical procedures | Systematic Assessment | Treated by peroperative cerclage of the femur. |
|
| Vascular Injury | Vascular disorders | Systematic Assessment | Treated by suture and vascular surgical exploration |
|
| Fracture femur | Surgical and medical procedures | Systematic Assessment | Treated by plate osteosynthesis. |
|
| Pseudoarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Treated by implantation of a nail. |
|
| Suspicion infection | Infections and infestations | Systematic Assessment | Hospitalization |
|
| Axonal mononeuropathy | Nervous system disorders | Systematic Assessment | Treated by move of the knee. |
|
| Total Knee Arthroplasty Left | Surgical and medical procedures | Systematic Assessment |
|
| Fall | Social circumstances | Systematic Assessment |
|
| Fracture of Trochanter | Surgical and medical procedures | Systematic Assessment | Treated by Cerclage |
|
| Haematoma | Blood and lymphatic system disorders | Systematic Assessment | Treated by Lavage and antibiotic |
|
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment | Treated by change of the heart treatment. |
|
| Transfusion Reaction | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D005264 |
| Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D004204 | Joint Dislocations |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |