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Rheumatoid ArthritisPhase 4NCT01134445

An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

A Phase 4 study testing DePuy Proxima™ Hip in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 4 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
DePuy Proxima™ Hip
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
4 sitesin 4 countries
Study dates
1 Feb 2010to 1 Jun 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

France1 site

  • Hospital Belle Isle

    Metz

Other trials in France

Portugal1 site

  • Hospital de Santo Antonio

    Porto

Other trials in Portugal

Spain1 site

  • Hospital Clinic Barcelona

    Barcelona

Other trials in Spain

United Kingdom1 site

  • Pilgrim Hospital

    Boston

Other trials in United Kingdom

About this study

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

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.

Being tested
DePuy Proxima™ Hip
Keywords
Arthroplasty, Replacement, Hip, Conservative, Anatomic, Cementless
Medical subject headings
Arthritis, Rheumatoid, Osteoarthritis, Osteonecrosis, Hip Dislocation, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DePuy Proxima™ HipDevice

    A short, anatomic, cementless femoral component for use in total hip arthroplasty

Study groups in NCT01134445
Study groupRoleWhat they receive
DePuy Proxima™ HipOtherA short, anatomic, cementless femoral component for use in total hip arthroplasty
Receives: Device: DePuy Proxima™ Hip

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kaplan-Meier survivorship calculated at the five-year time-point

    Measured: 5yrs post surgery

Secondary outcomes (95)

  1. Annual Kaplan-Meier survivorship calculations

    Measured: 1yr post-surgery

  2. Harris Hip Score

    Measured: 6mths post-surgery

  3. Oxford Hip Score

    Measured: 3mths post-surgery

  4. UCLA Activity Score

    Measured: 3mths post-surgery

  5. Hip Outcome Score

    Measured: 3mths post-surgery

  6. EuroQol EQ-5D

    Measured: 3mths post-surgery

  7. Annual Kaplan-Meier survivorship calculations

    Measured: 2yrs post-surgery

  8. Annual Kaplan-Meier survivorship calculations

    Measured: 3yrs post-surgery

  9. Annual Kaplan-Meier survivorship calculations

    Measured: 4yrs post-surgery

  10. Annual Kaplan-Meier survivorship calculations

    Measured: 6yrs post-surgery

  11. Annual Kaplan-Meier survivorship calculations

    Measured: 7yrs post-surgery

  12. Annual Kaplan-Meier survivorship calculations

    Measured: 8yrs post-surgery

  13. Annual Kaplan-Meier survivorship calculations

    Measured: 9yrs post-surgery

  14. Annual Kaplan-Meier survivorship calculations

    Measured: 10yrs post-surgery

  15. Annual Kaplan-Meier survivorship calculations

    Measured: 11yrs post-surgery

  16. Annual Kaplan-Meier survivorship calculations

    Measured: 12yrs post-surgery

  17. Annual Kaplan-Meier survivorship calculations

    Measured: 13yrs post-surgery

  18. Annual Kaplan-Meier survivorship calculations

    Measured: 14yrs post-surgery

  19. Annual Kaplan-Meier survivorship calculations

    Measured: 15yrs post-surgery

  20. Harris Hip Score

    Measured: 1yr post-surgery

  21. Harris Hip Score

    Measured: 2yrs post-surgery

  22. Harris Hip Score

    Measured: 5yrs post-surgery

  23. Harris Hip Score

    Measured: 10yrs post-surgery

  24. Harris Hip Score

    Measured: 15yrs post-surgery

  25. Radiographic Analysis

    Measured: 3mths post-surgery

  26. Radiographic Analysis

    Measured: 6mths post-surgery

  27. Radiographic Analysis

    Measured: 1yr post-surgery

  28. Radiographic Analysis

    Measured: 2yrs post-surgery

  29. Radiographic Analysis

    Measured: 5yrs post-surgery

  30. Radiographic Analysis

    Measured: 10yrs post-surgery

  31. Radiographic Analysis

    Measured: 15 yrs post-surgery

  32. Oxford Hip Score

    Measured: 6mths post-surgery

  33. Oxford Hip Score

    Measured: 1yr post-sugery

  34. UCLA Activity Score

    Measured: 6mths post-surgery

  35. UCLA Activity Score

    Measured: 1yr post-surgery

  36. Hip Outcome Score

    Measured: 6mths post-surgery

  37. Hip Outcome Score

    Measured: 1yr post-surgery

  38. EuroQol EQ-5D

    Measured: 6mths post-surgery

  39. EuroQol EQ-5D

    Measured: 1yr post-surgery

  40. Oxford Hip Score

    Measured: 2yrs post-surgery

  41. Oxford Hip Score

    Measured: 3yrs post-surgery

  42. Oxford Hip Score

    Measured: 4yrs post-surgery

  43. Oxford Hip Score

    Measured: 5yrs post-surgery

  44. Oxford Hip Score

    Measured: 6yrs post-surgery

  45. Oxford Hip Score

    Measured: 7yrs post-surgery

  46. Oxford Hip Score

    Measured: 8yrs post-surgery

  47. Oxford Hip Score

    Measured: 9yrs post surgery

  48. Oxford Hip Score

    Measured: 10yrs post-surgery

  49. Oxford Hip Score

    Measured: 11yrs post-surgery

  50. Oxford Hip Score

    Measured: 12yrs post-surgery

  51. Oxford Hip Score

    Measured: 13yrs post-sugery

  52. Oxford Hip Score

    Measured: 14yrs post-surgery

  53. Oxford Hip Score

    Measured: 15yrs post-surgery

  54. UCLA Activity Score

    Measured: 2yrs post-surgery

  55. UCLA Activity Score

    Measured: 3yrs post-surgery

  56. UCLA Activity Score

    Measured: 4yrs post-surgery

  57. UCLA Activity Score

    Measured: 5yrs post-surgery

  58. UCLA Activity Score

    Measured: 6yrs post-surgery

  59. UCLA Activity Score

    Measured: 7yrs post-surgery

  60. UCLA Activity Score

    Measured: 8yrs post-surgery

  61. UCLA Activity Score

    Measured: 9yrs post-surgery

  62. UCLA Activity Score

    Measured: 10yrs post-surgery

  63. UCLA Activity Score

    Measured: 11yrs post-surgery

  64. UCLA Activity Score

    Measured: 12yrs post-surgery

  65. UCLA Activity Score

    Measured: 13yrs post-surgery

  66. UCLA Activity Score

    Measured: 14yrs post-surgery

  67. UCLA Activity Score

    Measured: 15yrs post-surgery

  68. Hip Outcome Score

    Measured: 2yrs post-surgery

  69. Hip Outcome Score

    Measured: 3yrs post-surgery

  70. Hip Outcome Score

    Measured: 4yrs post-surgery

  71. Hip Outcome Score

    Measured: 5yrs post-surgery

  72. Hip Outcome Score

    Measured: 6yrs post-surgery

  73. Hip Outcome Score

    Measured: 7yrs post-surgery

  74. Hip Outcome Score

    Measured: 8yrs post-surgery

  75. Hip Outcome Score

    Measured: 9yrs post-surgery

  76. Hip Outcome Score

    Measured: 10yrs post-surgery

  77. Hip Outcome Score

    Measured: 11yrs post-surgery

  78. Hip Outcome Score

    Measured: 12yrs post-surgery

  79. Hip Outcome Score

    Measured: 13yrs post-surgery

  80. Hip Outcome Score

    Measured: 14yrs post-surgery

  81. Hip Outcome Score

    Measured: 15yrs post-surgery

  82. EuroQol EQ-5D

    Measured: 2yrs post-surgery

  83. EuroQol EQ-5D

    Measured: 3yrs post-surgery

  84. EuroQol EQ-5D

    Measured: 4yrs post-surgery

  85. EuroQol EQ-5D

    Measured: 5yrs post-surgery

  86. EuroQol EQ-5D

    Measured: 6yrs post-surgery

  87. EuroQol EQ-5D

    Measured: 7yrs post-surgery

  88. EuroQol EQ-5D

    Measured: 8yrs post-surgery

  89. EuroQol EQ-5D

    Measured: 9yrs post-surgery

  90. EuroQol EQ-5D

    Measured: 10yrs post-surgery

  91. EuroQol EQ-5D

    Measured: 11yrs post-surgery

  92. EuroQol EQ-5D

    Measured: 12yrs post-surgery

  93. EuroQol EQ-5D

    Measured: 13yrs post-surgery

  94. EuroQol EQ-5D

    Measured: 14yrs post-surgery

  95. EuroQol EQ-5D

    Measured: 15yrs post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2010 (estimated)
  2. Study start1 Feb 2010
  3. Primary completion1 Jan 2016
  4. Study completion1 Jun 2016

Why it stopped: Study terminated early for business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01134445
Sponsor's protocol ID
CT07/02
Status last verified
Jun 2017
First submitted
5 Mar 2010
Last updated
26 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DePuy Proxima™ Hip in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, Portugal, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated early for business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan-Meier survivorship calculated at the five-year time-point (time frame: 5yrs post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01134445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.

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