Arthritis, Avascular Necrosis, Congenital Hip Dysplasia, Fracture of the Femoral Neck or Head, Osteoarthritis
Conditions
Brief summary
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.
Interventions
PROCEDUREAnterior Minimally Invasive Approach (AMIS)
Sponsors
Medacta International SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery. * Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)). * Patients must be willing to comply with the pre and post-operative evaluation schedule. * Patients with only one lower limb arthroplasty
Exclusion criteria
* Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism * Patients with osteoporosis (pre-op T-score \< -2,5) * Patients with significant comorbidities * Patients with both hip and knee arthroplasty * Patients with restricted mobility * Patient with severe hip contracture * Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | 6 weeks, 6 months, 1 year | 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. |
| Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. | 6 months, 1 year | 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. |
| Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6 months, 1 year | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quadra Group Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS) | 20 |
| AMIStem Group Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS) | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Quadra Group | AMIStem Group | Total |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 9 | 64 years STANDARD_DEVIATION 9.6 | 66 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 0-12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quadra Group | 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. | 1y postop BMD Gruen zone 7 minus baseline | -0.25 g/cm2 | Standard Deviation 0.12 |
| Quadra Group | 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. | 1y postop BMD Gruen zone 1 minus baseline | -0.04 g/cm2 | Standard Deviation 0.1 |
| Quadra Group | 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. | 1y postop BMD Gruen zone 2 minus baseline | -0.04 g/cm2 | Standard Deviation 0.14 |
| Quadra Group | 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. | 1y postop BMD Gruen zone 3 minus baseline | 0 g/cm2 | Standard Deviation 0.15 |
| Quadra Group | 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. | 1y postop BMD Gruen zone 4 minus baseline | -0.04 g/cm2 | Standard Deviation 0.05 |
| Quadra Group | 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. | 1y postop BMD Gruen zone 5 minus baseline | -0.02 g/cm2 | Standard Deviation 0.11 |
| Quadra Group | 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. | 1y postop BMD Gruen zone 6 minus baseline | -0.06 g/cm2 | Standard Deviation 0.14 |
| AMIStem Group | 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. | 1y postop BMD Gruen zone 7 minus baseline | -0.14 g/cm2 | Standard Deviation 0.19 |
| AMIStem Group | 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. | 1y postop BMD Gruen zone 4 minus baseline | 0.03 g/cm2 | Standard Deviation 0.1 |
| AMIStem Group | 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. | 1y postop BMD Gruen zone 1 minus baseline | 0.01 g/cm2 | Standard Deviation 0.13 |
| AMIStem Group | 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. | 1y postop BMD Gruen zone 6 minus baseline | -0.06 g/cm2 | Standard Deviation 0.1 |
| AMIStem Group | 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. | 1y postop BMD Gruen zone 2 minus baseline | 0.05 g/cm2 | Standard Deviation 0.17 |
| AMIStem Group | 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. | 1y postop BMD Gruen zone 5 minus baseline | 0.03 g/cm2 | Standard Deviation 0.16 |
| AMIStem Group | 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. | 1y postop BMD Gruen zone 3 minus baseline | 0.01 g/cm2 | Standard Deviation 0.21 |
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.
Time frame: 6 months, 1 year
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quadra Group | Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. | HAAS 6 months vs preoperative | 2.6 units on a scale (0-18) | Standard Deviation 2.2 |
| Quadra Group | Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. | HAAS 1y vs preoperative | 3.8 units on a scale (0-18) | Standard Deviation 2.2 |
| AMIStem Group | Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. | HAAS 6 months vs preoperative | 3.1 units on a scale (0-18) | Standard Deviation 2.1 |
| AMIStem Group | Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. | HAAS 1y vs preoperative | 4.1 units on a scale (0-18) | Standard Deviation 2.4 |
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.
Time frame: 6 weeks, 6 months, 1 year
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quadra Group | Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | HHS 6 weeks difference vs preoperative | 30.6 units on a scale (0-100) | Standard Deviation 17.8 |
| Quadra Group | Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | HHS 6 months difference vs preoperative | 36.8 units on a scale (0-100) | Standard Deviation 17 |
| Quadra Group | Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | HHS 1y difference vs preoperative | 41 units on a scale (0-100) | Standard Deviation 13.4 |
| AMIStem Group | Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | HHS 6 weeks difference vs preoperative | 36.7 units on a scale (0-100) | Standard Deviation 17.3 |
| AMIStem Group | Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | HHS 6 months difference vs preoperative | 48.4 units on a scale (0-100) | Standard Deviation 13.6 |
| AMIStem Group | Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score | HHS 1y difference vs preoperative | 51.3 units on a scale (0-100) | Standard Deviation 14.1 |
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.
Time frame: 6 months, 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Stem radiolucencies presence bigger than 2mm | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Stem subsidence | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Femoral component loosening | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Cup radiolucencies presence bigger than 2mm | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Cup migration | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Cup loosening | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y Stem radiolucencies presence bigger than 2mm | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y stem subsidence | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y femoral component loosening | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y cup radiolucencies presence bigger than 2mm | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y cup migration | 0 participants |
| Quadra Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y cup loosening | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y cup migration | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Stem radiolucencies presence bigger than 2mm | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y Stem radiolucencies presence bigger than 2mm | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Stem subsidence | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y cup radiolucencies presence bigger than 2mm | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Femoral component loosening | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y stem subsidence | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Cup radiolucencies presence bigger than 2mm | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y cup loosening | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Cup migration | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 1y femoral component loosening | 0 participants |
| AMIStem Group | Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. | 6M Cup loosening | 0 participants |