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
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.
Fracture of the Femoral Neck or Head
Congenital Hip Dysplasia
Procedure: Anterior Minimally Invasive Approach (AMIS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- 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 ] [ Designated as safety issue: No ]
- Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score [ Time Frame: 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]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. [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Quadra Group||Procedure: Anterior Minimally Invasive Approach (AMIS)|
|Active Comparator: AMIStem Group||Procedure: Anterior Minimally Invasive Approach (AMIS)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285843
|St. Elisabeth Dillingen|
|Dillingen an der Donau, Bayern, Germany, 89407|
|Principal Investigator:||Martin Nolde, Dr. Med.||DGOOC; BVO; BVASK|