N/A
N=40
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
Osteoarthritis · Arthritis · Avascular Necrosis · Fracture of the Femoral Neck or Head · Congenital Hip Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT01285843 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Sep 2014
Primary outcome: 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. — -0.04; 0.01; -0.04; 0.05 g/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anterior Minimally Invasive Approach (AMIS) (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medacta International SA
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
-0.04; 0.01; -0.04; 0.05; 0; 0.01 | — |
| SECONDARY Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score |
30.6; 36.7; 36.8; 48.4; 41; 51.3 | — |
| SECONDARY Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. |
2.6; 3.1; 3.8; 4.1 | — |
| SECONDARY Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01285843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.