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CompletedNCT00306930Updated Jul 29, 2014

Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

An interventional study of Acetabular cup in Osteoarthritis, Rheumatoid Arthritis and Arthritis, sponsored by DePuy Orthopaedics. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-07-29.

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

Phase
Not applicable
Study type
Interventional
Enrollment
1,593
Allocation
Non-randomized
Sex
All
01

Study summary

This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

Read the detailed description

The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

02

Conditions studied

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Arthritis
  • Avascular Necrosis
  • Acute Fracture

Keywords

  • Total Hip Replacement
  • post-traumatic arthritis
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 1,593 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

DePuy Orthopaedics is the lead sponsor of 42 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Primary hip replacement
  • Sufficient bone stock to support implant
  • Signed Informed Patient Consent form

Exclusion criteria

Exclusion Criteria:

  • Prior renal transplant
  • History of active joint sepsis
  • Recent high dose of corticosteroids
  • Primary or secondary carcinoma in the last 5 years
  • Neurological disease
  • Psychosocial disease that would limit rehabilitation
  • Use of structural bone graft
  • Simultaneous participation in another hip study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,593 participants (actual)

Study arms

  • Other
    A

    Acetabular cup replacement with total hip arthroplasty

    Device: Acetabular cup

Interventions

  • DeviceAcetabular cup

    Acetabular cup replacement

    Also known as: Pinnacle™ Cup

06

What researchers measure

Primary outcomes

  1. Survivorship

    Time frame: 5 years

Secondary outcomes

  1. Harris Hip Score

    Time frame: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.

  3. Short Form-36 (SF-36)

    Time frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.

07

Study locations

1 site
  • DePuy Orthopaedics
    Warsaw, Indiana 46581, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00306930
Lead sponsor
DePuy Orthopaedics
Responsible party
Sponsor
First posted
Mar 27, 2006
Start date
Jul 2000
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jul 29, 2014

Study contacts

Dave Whalen, BS, DC
study director · DePuy Orthopaedics

Oversight

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

Not currently enrolling

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

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