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. (see Contacts and Locations)
Verified July 2014 by DePuy International
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01635166
First received: February 6, 2012
Last updated: September 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Osteoarthritis
Post-traumatic Arthritis
Avascular Necrosis
Traumatic Femoral Fractures
Congenital Hip Dysplasia
Device: Delta Motion
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To determine survivorship of the DeltaMotion Cup System at 3 years


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: July 2012
Estimated Study Completion Date: March 2024
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Delta Motion
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635166

Contacts
Contact: Jack Mantel +44 113 387 7800 ext 7910 jmantel@its.jnj.com

Locations
India
Apollo Speciality hospital, 320 Anna Salai Active, not recruiting
Chennai, India, 600035
All India Institute of Medical Sciences, Ansari nagar, South Extension Active, not recruiting
New Dehli, India, 110029
United Kingdom
Newcastle Nuffield Withdrawn
Newcastle, United Kingdom
Robert Jones and Agnes Hunt Recruiting
Oswestry, United Kingdom
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT01635166     History of Changes
Other Study ID Numbers: CT11/01
Study First Received: February 6, 2012
Last Updated: September 8, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by DePuy International:
Arthroplasty
Replacement
Hip
Cementless
Ceramic on Ceramic

Additional relevant MeSH terms:
Hip Dislocation, Congenital
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Femoral Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Fractures, Bone
Wounds and Injuries
Leg Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014