An interventional study of Anterior Minimally Invasive Approach (AMIS) in Osteoarthritis, Arthritis and Avascular Necrosis, sponsored by Medacta International SA. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by Medacta International SA · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
Procedure: Anterior Minimally Invasive Approach (AMIS)
Procedure: 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.
Time frame: 0-12 months
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
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
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
| Milestone | Quadra Group | AMIStem Group |
|---|---|---|
| Started | 20 | 20 |
| Completed | 18 | 18 |
| Not completed | 2 | 2 |
| g/cm2 | Quadra Group | AMIStem Group |
|---|---|---|
| 1y postop BMD Gruen zone 1 minus baseline | -0.04 ± 0.10 | 0.01 ± 0.13 |
| 1y postop BMD Gruen zone 2 minus baseline | -0.04 ± 0.14 | 0.05 ± 0.17 |
| 1y postop BMD Gruen zone 3 minus baseline | 0 ± 0.15 | 0.01 ± 0.21 |
| 1y postop BMD Gruen zone 4 minus baseline | -0.04 ± 0.05 | 0.03 ± 0.10 |
| 1y postop BMD Gruen zone 5 minus baseline | -0.02 ± 0.11 | 0.03 ± 0.16 |
| 1y postop BMD Gruen zone 6 minus baseline | -0.06 ± 0.14 | -0.06 ± 0.10 |
| 1y postop BMD Gruen zone 7 minus baseline | -0.25 ± 0.12 | -0.14 ± 0.19 |
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.
| units on a scale (0-100) | Quadra Group | AMIStem Group |
|---|---|---|
| HHS 6 weeks difference vs preoperative | 30.6 ± 17.8 | 36.7 ± 17.3 |
| HHS 6 months difference vs preoperative | 36.8 ± 17 | 48.4 ± 13.6 |
| HHS 1y difference vs preoperative | 41 ± 13.4 | 51.3 ± 14.1 |
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.
| units on a scale (0-18) | Quadra Group | AMIStem Group |
|---|---|---|
| HAAS 6 months vs preoperative | 2.6 ± 2.2 | 3.1 ± 2.1 |
| HAAS 1y vs preoperative | 3.8 ± 2.2 | 4.1 ± 2.4 |
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.
| participants | Quadra Group | AMIStem Group |
|---|---|---|
| 6M Stem radiolucencies presence bigger than 2mm | 0 | 0 |
| 6M Stem subsidence | 0 | 0 |
| 6M Femoral component loosening | 0 | 0 |
| 6M Cup radiolucencies presence bigger than 2mm | 0 | 0 |
| 6M Cup migration | 0 | 0 |
| 6M Cup loosening | 0 | 0 |
| 1y Stem radiolucencies presence bigger than 2mm | 0 | 0 |
| 1y stem subsidence | 0 | 0 |
| 1y femoral component loosening | 0 | 0 |
| 1y cup radiolucencies presence bigger than 2mm | 0 | 0 |
| 1y cup migration | 0 | 0 |
| 1y cup loosening | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quadra Group | — | 1/20 (5%) | 0/20 (0%) |
| AMIStem Group | — | 0/20 (0%) | 0/20 (0%) |
| Event | Quadra Group | AMIStem Group |
|---|---|---|
| RevisionSurgical and medical procedures | 1/20 | 0/20 |
| Age, Continuous(years) | Quadra Group | AMIStem Group | Total |
|---|---|---|---|
| Mean | 69 ± 9 | 64 ± 9.6 | 66 ± 9.4 |
| Sex: Female, Male(Participants) | Quadra Group | AMIStem Group | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 9 | 8 | 17 |
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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