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

This study is currently recruiting participants.
Verified February 2013 by DePuy International
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01635166
First received: February 6, 2012
Last updated: February 20, 2013
Last verified: February 2013

February 6, 2012
February 20, 2013
July 2012
December 2016   (final data collection date for primary outcome measure)
Kaplan-Meier survivorship [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To determine survivorship of the DeltaMotion Cup System at 3 years
Same as current
Complete list of historical versions of study NCT01635166 on ClinicalTrials.gov Archive Site
  • Kaplan-Meier survivorship [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: No ]
    To determine survivorship of the DeltaMotion Cup System at 10 years
  • Harris Hip Score [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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.
Same as current
Not Provided
Not Provided
 
Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
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

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Post-traumatic Arthritis
  • Avascular Necrosis
  • Traumatic Femoral Fractures
  • Congenital Hip Dysplasia
Device: Delta Motion
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.
Delta Motion
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement
Intervention: Device: Delta Motion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
March 2024
December 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact: Jack Mantel +44 113 387 7800 ext 7910 jmantel@its.jnj.com
India,   United Kingdom
 
NCT01635166
CT11/01
No
DePuy International
DePuy International
Not Provided
Not Provided
DePuy International
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP