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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quadra Group

Group Type ACTIVE_COMPARATOR

Anterior Minimally Invasive Approach (AMIS)

Intervention Type PROCEDURE

AMIStem Group

Group Type ACTIVE_COMPARATOR

Anterior Minimally Invasive Approach (AMIS)

Intervention Type PROCEDURE

Interventions

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Anterior Minimally Invasive Approach (AMIS)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No