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.

Medacta International SA1 site in 1 country40 target enrollmentSeptember 1, 2010

ConditionsOsteoarthritis Arthritis Avascular Necrosis Fracture of the Femoral Neck or Head Congenital Hip Dysplasia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Medacta International SA
Enrollment: 40
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 1, 2010

End Date

September 1, 2012

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medacta International SA

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.(6 months, 1 year)
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.(6 months, 1 year)
Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score(6 weeks, 6 months, 1 year)