NCT00306930

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,593

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

12.4 years

First QC Date

March 23, 2006

Last Update Submit

July 28, 2014

Conditions

OsteoarthritisRheumatoid ArthritisArthritisAvascular NecrosisAcute Fracture

Keywords

Total Hip Replacementpost-traumatic arthritis

Outcome Measures

Primary Outcomes (1)

  • Survivorship

    5 years

Secondary Outcomes (3)

  • Harris Hip Score

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

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

  • Short Form-36 (SF-36)

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

Study Arms (1)

A

OTHER

Acetabular cup replacement with total hip arthroplasty

Device: Acetabular cup

Interventions

Acetabular cupDEVICE

Acetabular cup replacement

Also known as: Pinnacle™ Cup
A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DePuy Orthopaedics

Warsaw, Indiana, 46581, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidArthritisOsteonecrosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dave Whalen, BS, DC

    DePuy Orthopaedics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 27, 2006

Study Start

July 1, 2000

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(1)