- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01285843
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bayern
-
Dillingen an der Donau, Bayern, Germany, 89407
- St. Elisabeth Dillingen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Quadra Group
|
|
Active Comparator: AMIStem Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
0-12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
6 weeks, 6 months, 1 year
|
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.
|
6 months, 1 year
|
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.
|
6 months, 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Nolde, Dr. Med., DGOOC; BVO; BVASK
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P01.004.14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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