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A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement

This study has been withdrawn prior to enrollment.
(Site Principal Investigator became seriously ill, so study abandoned before the start of recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00208429
First Posted: September 21, 2005
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DePuy International
  Purpose
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-on-metal 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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship calculated at the five-year time-point. [ Time Frame: 5 yrs post surgery ]

Secondary Outcome Measures:
  • Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score [ Time Frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ]
  • Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score [ Time Frame: Annually up to 15 yrs post-surgery ]
  • Kaplan-Meier survivorship [ Time Frame: Annually up to 15 yrs post-surgery ]

Enrollment: 0
Actual Study Start Date: July 1, 2004
Estimated Study Completion Date: July 1, 2019
Estimated Primary Completion Date: July 1, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pinnacle Acetabular System Device: Pinnacle Acetabular System

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 a cementless acetabular component and a metal on polyethylene bearing.

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) Subjects undergoing simultaneous bilateral hip operation.

iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.

v) Women who are pregnant.

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

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

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

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208429     History of Changes
Other Study ID Numbers: CT03/40
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 28, 2017
Last Verified: June 2017

Keywords provided by DePuy International:
Hip
Cementless

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Fractures, Bone
Necrosis
Femoral Fractures
Hip Dislocation
Hip Dislocation, Congenital
Slipped Capital Femoral Epiphyses
Collagen Diseases
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Pathologic Processes
Leg Injuries
Joint Dislocations
Bone Diseases
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Osteochondrodysplasias
Bone Diseases, Developmental
Epiphyses, Slipped