Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01635166|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2012
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis Traumatic Femoral Fractures Congenital Hip Dysplasia||Device: Delta Motion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the DeltaMotion Cup System in Subjects Requiring a Total Hip Replacement|
|Actual Study Start Date :||July 1, 2012|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 1, 2024|
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement
Device: Delta Motion
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.
- Kaplan-Meier survivorship [ Time Frame: 3 years ]To determine survivorship of the DeltaMotion Cup System at 3 years
- Kaplan-Meier survivorship [ Time Frame: 10yrs post-surgery ]To determine survivorship of the DeltaMotion Cup System at 10 years
- Harris Hip Score [ Time Frame: 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 [ Time Frame: 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.
- University of California Los Angeles (UCLA) Score [ Time Frame: 10yrs post-surgery ]Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement
- Western Ontario and McMaster Universities (WOMAC) Score [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635166
|Apollo Speciality hospital, 320 Anna Salai|
|Chennai, India, 600035|
|All India Institute of Medical Sciences, Ansari nagar, South Extension|
|New Dehli, India, 110029|
|Robert Jones and Agnes Hunt|
|Oswestry, United Kingdom|