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. (see Contacts and Locations)
Verified June 2013 by DePuy International
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01134445
First received: March 5, 2010
Last updated: June 12, 2013
Last verified: June 2013
  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
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: 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: June 12, 2013
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:
Hip Dislocation, Congenital
Hip Dislocation
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
Dislocations
Hip Injuries
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on August 28, 2014