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TerminatedNCT01383824Updated May 27, 2016

A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery

An interventional study of Silent™ Hip in Primary Arthritis and Secondary Arthritis, sponsored by DePuy International. Terminated at 9 sites in 5 countries. Open to participants aged Up to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-27.

Sponsored by DePuy International · Not applicable, Interventional, and Treatment

Why this study was terminated
Rationalization of the Silent Hip Prosthesis for business reasons only
Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Not applicable
Ages
Up to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Primary Arthritis
  • Secondary Arthritis

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Keywords

  • Hip Replacement
  • Femoral Component
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 89 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

DePuy International is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
89 participants (actual)

Study arms

  • Other
    Silent™ Hip

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

    Device: Silent™ Hip

Interventions

  • DeviceSilent™ Hip

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

06

What researchers measure

Primary outcomes

  1. Kaplan-Meier survivorship

    Time frame: 5 years post-surgery

Secondary outcomes

  1. Oxford Hip Score

    Time frame: 6 weeks-6 mths

  2. University of California Los Angeles (UCLA) Activity Score

    Time frame: 6 weeks-6 mths

  3. EuroQol EQ-5D

    Time frame: 6 weeks-6 mths

  4. Harris Hip Score

    Time frame: 6 weeks-6 mths

  5. Radiographic analysis

    Time frame: pre-discharge

  6. Oxford Hip Score

    Time frame: 2 years

  7. Oxford Hip Score

    Time frame: 3 years

  8. Oxford Hip Score

    Time frame: 4 Years

  9. Oxford Hip Score

    Time frame: 5 years

  10. Oxford Hip Score

    Time frame: 6 Years

  11. Oxford Hip Score

    Time frame: 7 Years

  12. Oxford Hip Score

    Time frame: 8 Years

  13. Oxford Hip Score

    Time frame: 9 years

  14. Oxford Hip Score

    Time frame: 10 Years

  15. Oxford Hip Score

    Time frame: 11 Years

  16. Oxford Hip Score

    Time frame: 12 Years

  17. Oxford Hip Score

    Time frame: 13 Years

  18. Oxford Hip Score

    Time frame: 14 Years

  19. Oxford Hip Score

    Time frame: 15 Years

  20. University of California Los Angeles (UCLA) Activity Score

    Time frame: 2 years

  21. University of California Los Angeles (UCLA) Activity Score

    Time frame: 3 years

  22. University of California Los Angeles (UCLA) Activity Score

    Time frame: 4 Years

  23. University of California Los Angeles (UCLA) Activity Score

    Time frame: 5 Years

  24. University of California Los Angeles (UCLA) Activity Score

    Time frame: 6 Years

  25. University of California Los Angeles (UCLA) Activity Score

    Time frame: 7 Years

  26. University of California Los Angeles (UCLA) Activity Score

    Time frame: 8 Years

  27. University of California Los Angeles (UCLA) Activity Score

    Time frame: 9 years

  28. University of California Los Angeles (UCLA) Activity Score

    Time frame: 10 Years

  29. University of California Los Angeles (UCLA) Activity Score

    Time frame: 11 Years

  30. University of California Los Angeles (UCLA) Activity Score

    Time frame: 12 Years

  31. University of California Los Angeles (UCLA) Activity Score

    Time frame: 13 Years

  32. University of California Los Angeles (UCLA) Activity Score

    Time frame: 14 Years

  33. University of California Los Angeles (UCLA) Activity Score

    Time frame: 15 years

  34. EuroQol EQ-5D

    Time frame: 2 Years

  35. EuroQol EQ-5D

    Time frame: 3 Years

  36. EuroQol EQ-5D

    Time frame: 4 Years

  37. EuroQol EQ-5D

    Time frame: 5 Years

  38. EuroQol EQ-5D

    Time frame: 6 years

  39. EuroQol EQ-5D

    Time frame: 7 years

  40. EuroQol EQ-5D

    Time frame: 8 Years

  41. EuroQol EQ-5D

    Time frame: 9 Years

  42. EuroQol EQ-5D

    Time frame: 10 Years

  43. EuroQol EQ-5D

    Time frame: 11 Years

  44. EuroQol EQ-5D

    Time frame: 12 Years

  45. EuroQol EQ-5D

    Time frame: 13 Years

  46. EuroQol EQ-5D

    Time frame: 14 Years

  47. EuroQol EQ-5D

    Time frame: 15 Years

  48. Harris Hip Score

    Time frame: 2 Years

  49. Harris Hip Score

    Time frame: 5 Years

  50. Harris Hip Score

    Time frame: 10 Years

  51. Harris Hip Score

    Time frame: 15 Years

  52. Radiographic analysis

    Time frame: 6 weeks - 6 mths

  53. Radiographic analysis

    Time frame: 1 year

  54. Radiographic analysis

    Time frame: 2 Years

  55. Radiographic analysis

    Time frame: 5 Years

  56. Radiographic analysis

    Time frame: 10 years

  57. Radiographic analysis

    Time frame: 15 Years

07

Study locations

9 sites
  • Sygehus Sønderjyllands
    Sønderborg, Denmark
  • Orthopädie Kupfalz
    Speyer, Germany
  • Orthopaedic Clinic University La Sapienza
    Rome, Italy
  • Hospital Nisa Sevilla-Aljarafe
    Sevilla, Spain
  • Hospital San Juan de Dios del Aljarafe
    Sevilla, Spain
  • Hospital Santa Ángela De La Cruz
    Sevilla, Spain
  • Princess Alexandra Hospital
    Harlow, Essex, United Kingdom
  • The Rivers Hospital
    Sawbridgeworth, Hertfordshire, United Kingdom
  • Wrightington Hospital
    Wrightington, Lancashire WN6 9EP, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01383824
Lead sponsor
DePuy International
Responsible party
Sponsor
First posted
Jun 28, 2011
Start date
Jan 2011
Primary completion
Jul 2013
Completion
Jul 2015
Last update
May 27, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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