Trial Outcomes & Findings for Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component (NCT NCT01285843)
NCT ID: NCT01285843
Last Updated: 2025-10-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
0-12 months
Results posted on
2025-10-09
Participant Flow
Participant milestones
| Measure |
Quadra Group
Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
|
AMIStem Group
Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component
Baseline characteristics by cohort
| Measure |
Quadra Group
n=20 Participants
Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
|
AMIStem Group
n=20 Participants
Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 9 • n=93 Participants
|
64 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
66 years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 0-12 monthsOutcome measures
| Measure |
Quadra Group
n=18 Participants
Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
|
AMIStem Group
n=18 Participants
Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
|
|---|---|---|
|
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
|
0.05 g/cm2
Standard Deviation 0.17
|
|
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
|
0.01 g/cm2
Standard Deviation 0.21
|
|
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
|
-0.06 g/cm2
Standard Deviation 0.10
|
|
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
|
-0.14 g/cm2
Standard Deviation 0.19
|
|
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 0.10
|
0.01 g/cm2
Standard Deviation 0.13
|
|
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
|
0.03 g/cm2
Standard Deviation 0.10
|
|
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
|
0.03 g/cm2
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 6 weeks, 6 months, 1 yearPopulation: 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).
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.
Outcome measures
| Measure |
Quadra Group
n=20 Participants
Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
|
AMIStem Group
n=20 Participants
Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
|
|---|---|---|
|
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
|
36.7 units on a scale (0-100)
Standard Deviation 17.3
|
|
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
|
48.4 units on a scale (0-100)
Standard Deviation 13.6
|
|
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
|
51.3 units on a scale (0-100)
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 6 months, 1 yearPopulation: 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).
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.
Outcome measures
| Measure |
Quadra Group
n=20 Participants
Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
|
AMIStem Group
n=20 Participants
Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
|
|---|---|---|
|
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
|
3.1 units on a scale (0-18)
Standard Deviation 2.1
|
|
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
|
4.1 units on a scale (0-18)
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 months, 1 yearStability 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.
Outcome measures
| Measure |
Quadra Group
n=18 Participants
Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
|
AMIStem Group
n=18 Participants
Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
|
|---|---|---|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
6M Cup radiolucencies presence bigger than 2mm
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
6M Cup migration
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
6M Stem radiolucencies presence bigger than 2mm
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
6M Stem subsidence
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
6M Femoral component loosening
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
6M Cup loosening
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
1y Stem radiolucencies presence bigger than 2mm
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
1y stem subsidence
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
1y femoral component loosening
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
1y cup radiolucencies presence bigger than 2mm
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
1y cup migration
|
0 participants
|
0 participants
|
|
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
1y cup loosening
|
0 participants
|
0 participants
|
Adverse Events
Quadra Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
AMIStem Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quadra Group
n=20 participants at risk
Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
|
AMIStem Group
n=20 participants at risk
Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
|
|---|---|---|
|
Surgical and medical procedures
Revision
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Other adverse events
Adverse event data not reported
Additional Information
Ing. Elisa Bonacina, Clinical Data Manager
Medacta International
Phone: +41 91 696 60 60
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER