An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
This study is currently recruiting participants.
Verified October 2012 by DePuy International
Sponsor:
DePuy International
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01134445
First received: March 5, 2010
Last updated: October 8, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to monitor the performance of the DePuy PROXIMA™ 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 |
|---|---|---|
|
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis Traumatic Femoral Fractures Congenital Hip Dysplasia |
Device: DePuy Proxima™ 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: | Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy PROXIMA™ Hip in Subjects With Indications Suitable for a Primary Total Hip Arthroplasty |
Resource links provided by NLM:
Further study details as provided by DePuy International:
Primary Outcome Measures:
- Kaplan-Meier survivorship calculated at the five-year time-point [ Time Frame: 5yrs post surgery ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 1yr post-surgery ] [ Designated as safety issue: Yes ]
- Harris Hip Score [ Time Frame: 6mths post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 3mths post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 3mths post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 3mths post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 3mths post-surgery ] [ Designated as safety issue: No ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 3yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 4yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 6yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 7yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 8yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 9yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 11yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 12yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 13yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 14yrs post-surgery ] [ Designated as safety issue: Yes ]
- Annual Kaplan-Meier survivorship calculations [ Time Frame: 15yrs post-surgery ] [ Designated as safety issue: Yes ]
- Harris Hip Score [ Time Frame: 1yr post-surgery ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: No ]
- Harris Hip Score [ Time Frame: 15yrs post-surgery ] [ Designated as safety issue: No ]
- Radiographic Analysis [ Time Frame: 3mths post-surgery ] [ Designated as safety issue: No ]
- Radiographic Analysis [ Time Frame: 6mths post-surgery ] [ Designated as safety issue: No ]
- Radiographic Analysis [ Time Frame: 1yr post-surgery ] [ Designated as safety issue: No ]
- Radiographic Analysis [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: No ]
- Radiographic Analysis [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: No ]
- Radiographic Analysis [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: No ]
- Radiographic Analysis [ Time Frame: 15 yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 6mths post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 1yr post-sugery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 6mths post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 1yr post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 6mths post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 1yr post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 6mths post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 1yr post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 3yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 4yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 6yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 7yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 8yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 9yrs post surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 11yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 12yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 13yrs post-sugery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 14yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 15yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 3yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 4yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 6yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 7yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 8yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 9yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 11yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 12yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 13yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 14yrs post-surgery ] [ Designated as safety issue: No ]
- UCLA Activity Score [ Time Frame: 15yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 3yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 4yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 6yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 7yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 8yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 9yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 11yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 12yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 13yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 14yrs post-surgery ] [ Designated as safety issue: No ]
- Hip Outcome Score [ Time Frame: 15yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 3yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 4yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 6yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 7yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 8yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 9yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 10yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 11yrs post-surgery ] [ Designated as safety issue: Yes ]
- EuroQol EQ-5D [ Time Frame: 12yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 13yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 14yrs post-surgery ] [ Designated as safety issue: No ]
- EuroQol EQ-5D [ Time Frame: 15yrs post-surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | January 2026 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
DePuy Proxima™ Hip
A short, anatomic, cementless femoral component for use in total hip arthroplasty
|
Device: DePuy Proxima™ Hip
A short, anatomic, cementless femoral component for use in total hip arthroplasty
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects between 18 and 70 years of age.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups.
- Subjects who are scheduled to undergo a primary THR whom the surgeon considers to be suitable for the DePuy PROXIMATM hip femoral prosthesis.
Exclusion Criteria:
- Subjects with active local or systemic infection
- Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- Subjects with poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
- Subjects with Charcot's or Paget's disease.
- Subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the proximal femur.
- Subjects with severe osteoporosis.
- Subjects with previous proximal femoral fractures.
- 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.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- Subjects who are currently involved in any injury litigation claims.
- Subjects for whom the surgical procedure is a revision of a previous THR, hemi-arthroplasty or hip resurfacing
- Subjects who have previously undergone osteotomy or arthrodesis of the hip.
- Subjects undergoing a simultaneous bilateral hip operation.
- Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
- Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134445
Contacts
| Contact: Jack Mantel, M.A. | +44 113 387 7800 ext 7961 | jmantel@its.jnj.com |
Locations
| Czech Republic | |
| Plzen Hospital | Withdrawn |
| Plzen, Czech Republic | |
| France | |
| Hospital Belle Isle | Terminated |
| Metz, France | |
| Portugal | |
| Hospital de Santo Antonio | Recruiting |
| Porto, Portugal | |
| Spain | |
| Hospital Clinic Barcelona | Recruiting |
| Barcelona, Spain | |
| United Kingdom | |
| Pilgrim Hospital | Active, not recruiting |
| Boston, United Kingdom | |
| Bradford Royal | Withdrawn |
| Bradford, United Kingdom | |
Sponsors and Collaborators
DePuy International
More Information
No publications provided
| Responsible Party: | DePuy International |
| ClinicalTrials.gov Identifier: | NCT01134445 History of Changes |
| Other Study ID Numbers: | CT07/02 |
| Study First Received: | March 5, 2010 |
| Last Updated: | October 8, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by DePuy International:
|
Arthroplasty Replacement Hip |
Conservative Anatomic Cementless |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Femoral Fractures Hip Dislocation, Congenital 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 May 21, 2013