Congenital Dislocations, Femur Head Necrosis, Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis
Conditions
Keywords
Arthroplasty, Hip Replacement, Ceramic, Acetabular cup, Femoral stem
Brief summary
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.
Interventions
None listed
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient implanted with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup. * Aged of more than 18 years at the time of the surgery. * Patient with a follow-up of at least 2 years after surgery based on a consecutive and exhaustive series of patients operated within the inclusion period. * Able to understand information to participate to the study.
Exclusion criteria
* Patient having a tumoral pathology. * Patient having expressed opposition to the study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 2-year follow-up visit | * Surgical incidents. * Post-operative complications. * Failure and revisions analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Performance: Mobility | Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| General Performance: Objective Clinical Score (PMA) | Baseline | 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). |
| General Performance: Radiological Assessment. | 2-year Follow-up visit | Radiological assessment is based on : * Cup radiological signs of osteolysis or radiolucencies. * Stem radiological signs of osteolysis or radiolucencies. * Ossifications according to Brooker classification from class I: Ossification around the hip joint. to class IV: shows apparent bone ankylosis of the hip. (i.e Class 0 = no ossification) * Other Radiological signs |
Participant flow
Recruitment details
All patients who received the same Total Hip Replacement system for primary hip replacement between July and October 2010 were contacted for study participation.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Patient not available for the 2y visit | 18 |
| Overall Study | Pt. couldn't come due to med. condition | 1 |
| Overall Study | Pt. didn't want to come for the 2y visit | 31 |
Baseline characteristics
| Characteristic | Total Hip Replacement Using a Ceramic Friction Pair |
|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 9 |
| Region of Enrollment France | 80 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 80 |
| serious Total, serious adverse events | 1 / 80 |
Outcome results
Primary
Number of Participants With Adverse Events
* Surgical incidents. * Post-operative complications. * Failure and revisions analysis.
Time frame: 2-year follow-up visit
Population: The total of 80 patients were seen for their 2-Year follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Hip Replacement Using a Ceramic Friction Pair | Number of Participants With Adverse Events | 2 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.
Time frame: Baseline
Population: 80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Extension | -1 Degrees | Standard Deviation 6 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Flexion | 89 Degrees | Standard Deviation 12 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Adduction | 17 Degrees | Standard Deviation 9 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Abduction | 20 Degrees | Standard Deviation 10 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | External rotation | 20 Degrees | Standard Deviation 9 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Internal rotation | 7 Degrees | Standard Deviation 13 |
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.
Time frame: 2-year Follow-up visit
Population: 80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Extension | 0 Degrees | Standard Deviation 1 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Flexion | 107 Degrees | Standard Deviation 13 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Adduction | 26 Degrees | Standard Deviation 9 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Abduction | 34 Degrees | Standard Deviation 9 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | External rotation | 30 Degrees | Standard Deviation 7 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Mobility | Internal rotation | 21 Degrees | Standard Deviation 9 |
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).
Time frame: Baseline
Population: Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Objective Clinical Score (PMA) | Pain score | 1.9 score on a scale | Standard Deviation 1.1 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Objective Clinical Score (PMA) | Mobility score | 5.1 score on a scale | Standard Deviation 0.9 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Objective Clinical Score (PMA) | Walking score | 4.5 score on a scale | Standard Deviation 0.7 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Objective Clinical Score (PMA) | Total PMA score | 11.5 score on a scale | Standard Deviation 1.7 |
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).
Time frame: 2-year follow-up visit
Population: Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Objective Clinical Score (PMA) | Mobility score | 6.0 score on a scale | Standard Deviation 1 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Objective Clinical Score (PMA) | Pain score | 5.8 score on a scale | Standard Deviation 0.6 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Objective Clinical Score (PMA) | Walking score | 5.9 score on a scale | Standard Deviation 0.5 |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Objective Clinical Score (PMA) | Total PMA score | 17.7 score on a scale | Standard Deviation 1 |
Other Pre-specified
General Performance: Radiological Assessment.
Radiological assessment is based on : * Cup radiological signs of osteolysis or radiolucencies. * Stem radiological signs of osteolysis or radiolucencies. * Ossifications according to Brooker classification from class I: Ossification around the hip joint. to class IV: shows apparent bone ankylosis of the hip. (i.e Class 0 = no ossification) * Other Radiological signs
Time frame: 2-year Follow-up visit
Population: Patients with X-ray data available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Radiological Assessment. | Cups without radiological signs | 80 participants |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Radiological Assessment. | Stems without radiological signs | 80 participants |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Radiological Assessment. | Ossifications (Brooker classification = 0) | 70 participants |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Radiological Assessment. | Ossifications (Brooker classification = 1) | 6 participants |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Radiological Assessment. | Ossifications (Brooker classification = 2) | 2 participants |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Radiological Assessment. | Ossifications (Brooker classification = 3) | 2 participants |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Radiological Assessment. | Ossifications (Brooker classification = 4) | 0 participants |
| Total Hip Replacement Using a Ceramic Friction Pair | General Performance: Radiological Assessment. | Other radiological signs | 0 participants |