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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 Avenir Müller Hip Stem.
The objective of this post market surveillance study is to obtain outcome data on the Avenir Müller Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.
This is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. Each case enrolled has received the Avenir Müller Hip Stem for a primary hip arthroplasty. The Avenir Müller Hip Stem is CE marked (European Conformity) and commercially available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients suffering from severe hip pain and disability | Patients in need of a total hip arthroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem. | Device | Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem. |
| 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 with the patient 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 (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, 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 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). | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation of Safety Based on Complications | Number of patients with adverse events related to the implant will be reported. Adverse events include: dislocations of the hip, revisions and removals of the implant components. Here, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the complications occured from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from severe hip pain and disability requiring a total hip arthroplasty.
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| Name | Affiliation | Role |
|---|---|---|
| Paola Vivoda | Zimmer Biomet | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30415580 | Result | Erivan R, Villatte G, Brientini JM, Kreider D, Descamps S, Boisgard S. 7-year results of primary total hip arthroplasty with the uncemented Avenir stem. Hip Int. 2019 Jul;29(4):418-423. doi: 10.1177/1120700018810211. Epub 2018 Nov 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Suffering From Severe Hip Pain and Disability | Patients in need of a total hip arthroplasty. Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Suffering From Severe Hip Pain and Disability | Patients in need of a total hip arthroplasty. Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem and who met the study 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 | Evaluation of Pain and Functional Performance Determined by the Harris Hip Score | The Harris Hip Score is a questionnaire filled by the surgeon with the patient 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 (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, 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 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). | The HHS values are within the interval 0-100 points and the higher the score is, the better the outcome is for the individuals. The results are interpreted with the following ratings: <70 points = poor result; 70-79 points = fair, 80-89 points = good, and 90-100 points = excellent. Number Of Unilateral Patients: 68; Number Of Bilateral Patients:7. Here, the data at 10 year post surgery of 75 patients (82 hips) were available for analysis. | Posted | Mean | Standard Deviation | score on a scale | 10 years |
The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative).
All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
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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 Suffering From Severe Hip Pain and Disability | Patients in need of a total hip arthroplasty. Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture of Femoral Shaft | Surgical and medical procedures | Systematic Assessment | Treated by revision of the Avenir Muller Stem |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Polymyalgia rheumatica | Congenital, familial and genetic disorders | Systematic Assessment | Treated by medical corticosteroid. |
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| 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 | Oct 6, 2009 | Jul 2, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D001172 | Arthritis, Rheumatoid |
| D006620 | Hip Fractures |
| D006617 | Hip Dislocation |
| D010020 | Osteonecrosis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| up to 10 years |
| Survivorship of the Implant | Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method. Here, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the revisions could happen from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. Even if a patient did not come back for a visit, the information if the implant was still in place was provided and taken into account for the survival analysis (gives higher numbers than for the clinical evaluation). | 10 years |
| 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 (BMI) kg/m2 | Mean | Standard Deviation | kg/m^2 |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Implants |
| Implants |
|
|
|
| Secondary | Confirmation of Safety Based on Complications | Number of patients with adverse events related to the implant will be reported. Adverse events include: dislocations of the hip, revisions and removals of the implant components. Here, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the complications occured from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. | Revisions due to any component (Avenir Muller Hip Stem, Acetabular Insert , Acetabular Cup...) complication. | Posted | Number | Patients | up to 10 years | Implants | Implants |
|
|
|
| Secondary | Survivorship of the Implant | Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method. Here, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the revisions could happen from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. Even if a patient did not come back for a visit, the information if the implant was still in place was provided and taken into account for the survival analysis (gives higher numbers than for the clinical evaluation). | Kaplan-Meier survival rate at 10 years post-surgery,with Avenir Muller Hip Stem revision for any reason as endpoint. Number of Unilateral Patients: 88; Number of Bilateral Patients: 4. Data of 88 patients,96 hips were received up to 10 years post surgery for the survival. Indeed, if a patient did not come back for a visit, the information if the implant was still in place was provided (gives higher numbers than for the clinical evaluation). | Posted | Number | percentage implant survival | 10 years | Implants | Implants |
|
|
|
| 3 |
| 141 |
| 17 |
| 141 |
| 14 |
| 141 |
|
| Bascule Implant cotyl | Surgical and medical procedures | Systematic Assessment | Treated by revision |
|
| Post traumatic Pain on acetabular | Social circumstances | Systematic Assessment |
|
| Cup pain after Trauma | Social circumstances | Systematic Assessment | Treated by revision of the Cup Head |
|
| Deep Infection (>6 Weeks | Infections and infestations | Systematic Assessment | Treated by the revision of the whole prosthesis |
|
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment | Treated by a pacemaker |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment | Treated with a catheter |
|
| Bascule Insert acetabular | Surgical and medical procedures | Systematic Assessment | Treated by revision of the cup head |
|
| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
|
| Myelofibrosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Reaction Due To Metal Bearing | Immune system disorders | Systematic Assessment |
|
| Metallosis | Product Issues | Systematic Assessment |
|
| Calcar crack | Surgical and medical procedures | Systematic Assessment |
|
| Deep Infection (>6 Weeks) | Infections and infestations | Systematic Assessment | Treated by rifadin and batrim |
|
| Scar Inflammation | Blood and lymphatic system disorders | Systematic Assessment | Treated by Amoxiciline |
|
| Death | General disorders | Systematic Assessment | Cause of Death unknown. |
|
| Stroke | Blood and lymphatic system disorders | Systematic Assessment |
|
|
| Kidney stone | Renal and urinary disorders | Systematic Assessment | Treated by Lithotripsy |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment | Treated by Medication |
|
| Stroke | Blood and lymphatic system disorders | Systematic Assessment | Treated by Catheter |
|
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment | Treated by Electrical Radioscopic Treatment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Treated by Antibiotics. |
|
| Respiratory Infection | Infections and infestations | Systematic Assessment | Treated by Antibiotics |
|
| Stroke | Blood and lymphatic system disorders | Systematic Assessment | Treated by operation |
|
| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
|
| Dislocation | Surgical and medical procedures | Systematic Assessment | Treated by reduction with general anaesthesia |
|
| Hodgkin's disease | Blood and lymphatic system disorders | Systematic Assessment | Treated by hospitalizations and chemotherapy |
|
| Nephrectomy L and Partiel R | Renal and urinary disorders | Systematic Assessment | Treated by surgery and hospitalization. |
|
| Instability | General disorders | Systematic Assessment | Kept under surveillance |
|
| Subluxation | Surgical and medical procedures | Systematic Assessment | Treated by hospitalisation traction Nonsteroidal anti-inflammatory drugs (NSAIDs) |
|
| Ankylosing Spondylartis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dislocation | Surgical and medical procedures | Systematic Assessment | Treated by reduction traction |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 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 |