The Metaphyseal Hip Prosthesis - Total Hip

Zimmer Biomet

Status

Completed

Conditions

Osteoarthritis of the Hip

Treatments

Device: Metaphyseal Hip Prosthesis

Device: Stanmore

Study type

Interventional

Funder types

Industry

Identifiers

NCT01501955

BMETEU.CR.EU88 MHP

Details and patient eligibility

About

The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.

Full description

The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement at short term (1 year) and long term (10 years).

Bone remodeling will be analyzed at 10 years using DEXA (Dual Energy X-Ray Absorptiometry (bone scan test)) measurements.

This is a single-center prospective study with 25 patients in the study and 25 in the control group in open Randomized Clinical Trial.

Enrollment

20 patients

Sex

All

Ages

55 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Candidates for a total hip replacement because of arthritis of the hip
Patients with a good general condition
Patients willing and able to participate in the clinical trial with a 10 years follow up and who have signed an inform consent
Males and females
Age between 55 and 75
Absence or little presence of osteoporotic bone (t>-2)
ASA score 1 and 2

Exclusion criteria

Patient with co morbidities that limit the physical abilities which may negatively influence the scores. Such co morbidities can for example be cardiac insufficiency or chronic respiratory diseases.
Severe systematic diseases such as rheumatic arthritis and SLE.
General osteoporosis (t<-2).
Hormonal conditions such as Paget disease, which reduces the bone density.
Diseases that can negatively influence the 10 years life expectancy.
Chronic use of corticosteroids.
Extreme overweight defined as BMI above 35.
Active bacterial infection.
Mental weakness which could negatively influence the postoperative recovery and influence the ability to complete pain scores and other questionnaires.
ASA score >2.