Avascular Necrosis, Congenital Hip Dysplasia, Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis, Traumatic Femoral Fractures
Conditions
Keywords
Arthroplasty, Replacement, Hip, Cementless, Ceramic on Ceramic
Brief summary
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.
Interventions
DEVICEDelta Motion
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.
Sponsors
DePuy International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier survivorship | 3 years | To determine survivorship of the DeltaMotion Cup System at 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 10yrs post-surgery | Change from baseline in the Harris Hip Score. The Harris Hip Score is used to measure the outcome of total hip replacement and covers the areas of pain, function, absence of deformity and range of motion. |
| Oxford Hip Score | 10yrs post-surgery | Change from baseline in the Oxford Hip Score. The Oxford hip score is a patient completed outcomes score which is designed to assess function and pain with patients undergoing hip replacement surgery. |
| Kaplan-Meier survivorship | 10yrs post-surgery | To determine survivorship of the DeltaMotion Cup System at 10 years |
| Western Ontario and McMaster Universities (WOMAC) Score | 10yrs post-surgery | Change from baseline in the WOMAC. WOMAC is a patient complete outcome score to assess pain, disability and joint stiffness in Osteoarthritis of the hip and knee |
| Radiological analysis | 10yrs post-surgery | * Acetabular Migration (vertical or horizontal) less than 5mm * Acetabular Migration (varus or valgus) less than 5 degrees * No loosening - absence of acetabular radiolucencies of greater than 2mm in two zones. |
| University of California Los Angeles (UCLA) Score | 10yrs post-surgery | Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement |
Countries
India, United Kingdom
Outcome results
None listed