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This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadra Group | Active Comparator |
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| AMIStem Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Minimally Invasive Approach (AMIS) | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component. | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity. The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Nolde, Dr. Med. | DGOOC; BVO; BVASK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elisabeth Dillingen | Dillingen an der Donau | Bavaria | 89407 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quadra Group | Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS) |
| FG001 | AMIStem Group | Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 6 weeks, 6 months, 1 year |
| Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. | The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative. | 6 months, 1 year |
| Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points. | 6 months, 1 year |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quadra Group | Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS) |
| BG001 | AMIStem Group | Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component. | Posted | Mean | Standard Deviation | g/cm2 | 0-12 months |
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| Secondary | Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity. The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative. | 20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HHS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra). | Posted | Mean | Standard Deviation | units on a scale (0-100) | 6 weeks, 6 months, 1 year |
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| Secondary | Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. | The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative. | 20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HAAS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra). | Posted | Mean | Standard Deviation | units on a scale (0-18) | 6 months, 1 year |
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| Secondary | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points. | Posted | Number | participants | 6 months, 1 year |
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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 | Quadra Group | Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS) | 1 | 20 | 0 | 20 | ||
| EG001 | AMIStem Group | Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS) | 0 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision | Surgical and medical procedures | revision | Non-systematic Assessment | Femoral neck fracture following an accident. The patient has been operated and revised |
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Both the investigator and Medacta have the right to publish or allow to be published the results of the trial. The investigator recognizes that Medacta has a special interest in the results of the trial and will submit manuscripts to Medacta prior to publication. If Medacta desires changes to be made, these are communicated to the investigator within 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ing. Elisa Bonacina, Clinical Data Manager | Medacta International | +41 91 696 60 60 | bonacina@medacta.ch |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D010020 | Osteonecrosis |
| D006618 | Hip Dislocation, Congenital |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Male |
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| 1y postop BMD Gruen zone 3 minus baseline |
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| 1y postop BMD Gruen zone 4 minus baseline |
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| 1y postop BMD Gruen zone 5 minus baseline |
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| 1y postop BMD Gruen zone 6 minus baseline |
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| 1y postop BMD Gruen zone 7 minus baseline |
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