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Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

Primary Purpose

Osteoarthritis, Rheumatoid Arthritis, Arthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acetabular cup

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total Hip Replacement, post-traumatic arthritis

Eligibility Criteria

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Inclusion Criteria: Primary hip replacement Sufficient bone stock to support implant Signed Informed Patient Consent form 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

Sites / Locations

DePuy Orthopaedics

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Acetabular cup replacement with total hip arthroplasty

Outcomes

Primary Outcome Measures

Survivorship

Secondary Outcome Measures

Harris Hip Score

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Short Form-36 (SF-36)

Full Information

NCT ID

NCT00306930

First Posted

March 23, 2006

Last Updated

July 28, 2014

Sponsor

DePuy Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT00306930

Brief Title

Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

Official Title

Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

July 2000 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy Orthopaedics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Rheumatoid Arthritis, Arthritis, Avascular Necrosis, Acute Fracture

Keywords

Total Hip Replacement, post-traumatic arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1593 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Acetabular cup replacement with total hip arthroplasty

Intervention Type

Device

Intervention Name(s)

Acetabular cup

Other Intervention Name(s)

Pinnacle™ Cup

Intervention Description

Acetabular cup replacement

Primary Outcome Measure Information:

Title

Survivorship

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Harris Hip Score

Time Frame

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

Title

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame

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

Title

Short Form-36 (SF-36)

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dave Whalen, BS, DC

Organizational Affiliation

DePuy Orthopaedics

Official's Role

Study Director

Facility Information:

Facility Name

DePuy Orthopaedics

City

Warsaw

State/Province

Indiana

ZIP/Postal Code

46581

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

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