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

Phase 4TerminatedNCT01635166

DePuy International250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (3)

Apollo Speciality hospital, 320 Anna Salai

Chennai, India

All India Institute of Medical Sciences, Ansari nagar, South Extension

New Dehli, India

Robert Jones and Agnes Hunt

Oswestry, United Kingdom

Outcomes

Primary Outcomes

Kaplan-Meier survivorship

To determine survivorship of the DeltaMotion Cup System at 3 years

Time frame: 3 years