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The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total hip replacement using a ceramic friction pair | Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events |
| 2-year follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| General Performance: Mobility | Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°). Normal values (usually observed range of motions) are: extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°). Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion. |
| Measure | Description | Time Frame |
|---|---|---|
| General Performance: Objective Clinical Score (PMA) | Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score). | Baseline |
| General Performance: Objective Clinical Score (PMA) |
Inclusion Criteria:
Exclusion Criteria:
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Cohort of European patients with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Piriou, MD, Prof. | Hôpital Universitaire Raymond Poincaré, Garches - France | Principal Investigator |
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All patients who received the same Total Hip Replacement system for primary hip replacement between July and October 2010 were contacted for study participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Hip Replacement Using a Ceramic Friction Pair | All patients were treated with a total hip replacement using a ceramic friction pair Biolox® delta, with a Meije Duo® cementless stem with HAP associated with a cementless double coating of plasma sprayed titanium and HAP Dynacup® acetabular cup. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
132 eligible patients were identified and contacted by the investigators: all patients were still implanted with the same THR system when contacted for study participation, including 2 patients who died before this contact: 80 patients were enrolled and completed the study per protocol at the 2-year follow-up visit without any protocol deviations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Hip Replacement Using a Ceramic Friction Pair | Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup |
| 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 | Number of Participants With Adverse Events |
| The total of 80 patients were seen for their 2-Year follow-up visit. | Posted | Number | participants | 2-year follow-up visit |
|
|
2 years
Adverse events were collected from surgery to last follow-up visit
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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 | Total Hip Replacement Using a Ceramic Friction Pair | Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Spiroid fracture of the thighbone due to patient fall 2 weeks after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture during surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Partial fracture of the Merckel, no additional procedure has been performed during the surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Trétout | Tornier SAS | +33 4 76 71 35 00 | nathalie.tretout@tornier.com |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline |
| General Performance: Mobility | Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°). Normal values (usually observed range of motions) are: extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°). Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion. | 2-year Follow-up visit |
Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score). |
| 2-year follow-up visit |
| General Performance: Radiological Assessment. | Radiological assessment is based on :
| 2-year Follow-up visit |
| Pt. couldn't come due to med. condition |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | General Performance: Mobility | Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°). Normal values (usually observed range of motions) are: extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°). Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion. | 80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities | Posted | Mean | Standard Deviation | Degrees | Baseline |
|
|
|
| Other Pre-specified | General Performance: Objective Clinical Score (PMA) | Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score). | Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | General Performance: Mobility | Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°). Normal values (usually observed range of motions) are: extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°). Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion. | 80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities | Posted | Mean | Standard Deviation | Degrees | 2-year Follow-up visit |
|
|
|
| Other Pre-specified | General Performance: Objective Clinical Score (PMA) | Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score). | Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit. | Posted | Mean | Standard Deviation | score on a scale | 2-year follow-up visit |
|
|
|
| Other Pre-specified | General Performance: Radiological Assessment. | Radiological assessment is based on :
| Patients with X-ray data available | Posted | Number | participants | 2-year Follow-up visit |
|
|
|
| 1 |
| 80 |
| 1 |
| 80 |
|
|
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| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| Title | Measurements |
|---|---|
|
| Abduction |
|
| External rotation |
|
| Internal rotation |
|
| Title | Measurements |
|---|---|
|
| Total PMA score |
|
| Title | Measurements |
|---|---|
|
| Abduction |
|
| External rotation |
|
| Internal rotation |
|
| Title | Measurements |
|---|---|
|
| Total PMA score |
|
| Title | Measurements |
|---|---|
|
| Ossifications (Brooker classification = 1) |
|
| Ossifications (Brooker classification = 2) |
|
| Ossifications (Brooker classification = 3) |
|
| Ossifications (Brooker classification = 4) |
|
| Other radiological signs |
|