A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery
This study is currently recruiting participants.
Verified February 2013 by DePuy International
Sponsor:
DePuy International
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01383824
First received: June 27, 2011
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to monitor the performance and of the Silent Hip™ 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 |
|---|---|---|
|
Primary Arthritis Secondary Arthritis |
Device: Silent™ Hip |
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 Silent™ Hip 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: 5 years post-surgery ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Oxford Hip Score [ Time Frame: 6 weeks-6 mths ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 6 weeks-6 mths ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 6 weeks-6 mths ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 6 weeks-6 mths ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: pre-discharge ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 9 years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 11 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 12 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 13 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 14 Years ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 9 years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 11 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 12 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 13 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 14 Years ] [ Designated as safety issue: No ]
- University of California Los Angeles (UCLA) Activity Score [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 9 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 11 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 12 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 13 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 14 Years ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: 6 weeks - 6 mths ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2029 |
| Estimated Primary Completion Date: | March 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Silent™ Hip
A short cementless, femoral component for use in total hip arthroplasty
|
Device: Silent™ Hip
A short cementless, femoral component for use in total hip arthroplasty
|
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study.
Exclusion Criteria:
- Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383824
Contacts
| Contact: Carol Picker, B.Sc. | +44 113 387 7800 ext 7815 | cpicker@its.jnj.com |
Locations
| Denmark | |
| Sygehus Sønderjyllands | Recruiting |
| Sønderborg, Denmark | |
| Germany | |
| Orthopädie Kupfalz | Not yet recruiting |
| Speyer, Germany | |
| Italy | |
| Orthopaedic Clinic University La Sapienza | Recruiting |
| Rome, Italy | |
| Spain | |
| Hospital San Juan de Dios del Aljarafe | Recruiting |
| Sevilla, Spain | |
| Hospital Santa Ángela De La Cruz | Recruiting |
| Sevilla, Spain | |
| Hospital Nisa Sevilla-Aljarafe | Recruiting |
| Sevilla, Spain | |
| United Kingdom | |
| Princess Alexandra Hospital | Recruiting |
| Harlow, Essex, United Kingdom | |
| The Rivers Hospital | Recruiting |
| Sawbridgeworth, Hertfordshire, United Kingdom | |
| Wrightington Hospital | Recruiting |
| Wrightington, Lancashire, United Kingdom, WN6 9EP | |
Sponsors and Collaborators
DePuy International
More Information
No publications provided
| Responsible Party: | DePuy International |
| ClinicalTrials.gov Identifier: | NCT01383824 History of Changes |
| Other Study ID Numbers: | CT09/02 |
| Study First Received: | June 27, 2011 |
| Last Updated: | February 20, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013