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A Single Centre Study to Assess the Long-Term Performance of the Pinnacle™ Cup With a Ceramic-on-Ceramic Bearing in Primary Total Hip Replacement
This study is currently recruiting participants.
Verified by DePuy International, March 2009
First Received: March 30, 2009   No Changes Posted
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00872222
  Purpose

The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a ceramic-on-ceramic bearing combination 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.


Condition Intervention Phase
Rheumatoid Arthritis
Osteoarthritis
Post-Traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Device: Pinnacle™ Acetabular System
Phase IV

MedlinePlus related topics: Fractures Osteoarthritis Osteonecrosis Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle™ Acetabular Cup Prosthesis With a Ceramic-on-Ceramic Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship at the five-year period [ Time Frame: 5yrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Kaplan-Meier survivorship calculations [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip Score [ Time Frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip score [ Time Frame: 3yrs, 4yrs, 6yrs, 8yrs, 9yrs, 11yrs, 12yrs, 13yrs and 14yrs post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2006
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pinnacle™ Acetabular System
    A cementless acetabular cup with ceramic liner for use in total hip replacement
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) Subjects undergoing revision hip replacement.

iii) Women who are pregnant.

iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

vi) Subjects who are currently involved in any injury litigation claims.

vii) Subjects undergoing a simultaneous bilateral hip operation.

viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.

ix) 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872222

Contacts
Contact: Michael Borroff, B.Sc., M.Sc +44 113 387 7800 ext 7910 mborroff@its.jnj.com

Locations
Czech Republic
St Anne's University Hospital Recruiting
Brno, Czech Republic
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: DePuy International Ltd ( Michael Borroff, B.Sc., M.Sc. Study Director )
Study ID Numbers: CT03/39
Study First Received: March 30, 2009
Last Updated: March 30, 2009
ClinicalTrials.gov Identifier: NCT00872222     History of Changes
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by DePuy International:
Hip
Cementless
Ceramic-on-Ceramic

Study placed in the following topic categories:
Autoimmune Diseases
Osteonecrosis
Collagen Diseases
Hip Dislocation
Osteoarthritis
Dislocations
Joint Diseases
Fractures, Bone
Wounds and Injuries
Arthritis, Rheumatoid
Disorders of Environmental Origin
Rheumatic Diseases
Bone Diseases
Musculoskeletal Abnormalities
Femoral Fractures
Necrosis
Musculoskeletal Diseases
Epiphyses, Slipped
Arthritis
Connective Tissue Diseases
Hip Dysplasia
Leg Injuries
Congenital Abnormalities
Hip Dislocation, Congenital

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Collagen Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases
Fractures, Bone
Wounds and Injuries
Arthritis, Rheumatoid
Disorders of Environmental Origin
Rheumatic Diseases
Bone Diseases
Musculoskeletal Abnormalities
Femoral Fractures
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Epiphyses, Slipped
Arthritis
Connective Tissue Diseases
Leg Injuries
Congenital Abnormalities
Hip Dislocation, Congenital

ClinicalTrials.gov processed this record on May 07, 2009