Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
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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 |
- Kaplan-Meier survivorship [ Time Frame: 3 years ] [ Designated as safety issue: No ]To determine survivorship of the DeltaMotion Cup System at 3 years
- 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 |
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| Contact: Jack Mantel | +44 113 387 7800 ext 7910 | jmantel@its.jnj.com |
| India | |
| Apollo Speciality hospital, 320 Anna Salai | Recruiting |
| Chennai, India, 600035 | |
| All India Institute of Medical Sciences, Ansari nagar, South Extension | Recruiting |
| New Dehli, India, 110029 | |
| United Kingdom | |
| Newcastle Nuffield | Recruiting |
| Newcastle, United Kingdom | |
| Robert Jones and Agnes Hunt | Recruiting |
| Oswestry, United Kingdom | |
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: | February 20, 2013 |
| 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 Femoral Fractures Necrosis Osteonecrosis Osteoarthritis 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 Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on June 18, 2013