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

Status

Completed

Conditions

Osteoarthritis

Fracture of the Femoral Neck or Head

Arthritis

Congenital Hip Dysplasia

Avascular Necrosis

Treatments

Procedure: Anterior Minimally Invasive Approach (AMIS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01285843

P01.004.14

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Volunteers

No Healthy Volunteers

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