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
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|ClinicalTrials.gov Identifier: NCT01285843|
Recruitment Status : Completed
First Posted : January 28, 2011
Results First Posted : September 15, 2014
Last Update Posted : October 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Arthritis Avascular Necrosis Fracture of the Femoral Neck or Head Congenital Hip Dysplasia||Procedure: Anterior Minimally Invasive Approach (AMIS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
|Active Comparator: Quadra Group||Procedure: Anterior Minimally Invasive Approach (AMIS)|
|Active Comparator: AMIStem Group||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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285843
|St. Elisabeth Dillingen|
|Dillingen an der Donau, Bayern, Germany, 89407|
|Principal Investigator:||Martin Nolde, Dr. Med.||DGOOC; BVO; BVASK|