Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2018-02-08

Brief Summary

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The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

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Detailed Description

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Conditions

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Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis Traumatic Femoral Fractures Congenital Hip Dysplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Delta Motion

A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement

Group Type OTHER

Delta Motion

Intervention Type DEVICE

A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.

Interventions

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Delta Motion

A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this Clinical Investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this Clinical Investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use

Exclusion Criteria

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this Clinical Investigation.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

iv) Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months.

v) Subjects who are currently involved in any injury litigation claims.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No