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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00872222
• Other study ID #: CT03/39
• Status: Terminated
• Phase: Phase 4
• First received: March 30, 2009
• Last updated: October 6, 2016
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Collagen Diseases
• Collagen Disorders
• Congenital Hip Dysplasia
• Femoral Fractures
• Fractures, Bone
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Nonunion of Femoral Fractures
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Slipped Capital Femoral Epiphyses
• Slipped Capital Femoral Epiphysis
• Traumatic Femoral Fractures

Intervention

Device:
• Pinnacle™ Acetabular System
A cementless acetabular cup with ceramic liner for use in total hip replacement

Locations

Country	Name	City	State
Czech Republic	St Anne's University Hospital	Brno

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier survivorship at the five-year period		5yrs	Yes
Secondary	Kaplan-Meier survivorship calculations		Annually	Yes
Secondary	Harris Hip Score		6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery	No
Secondary	Radiographic analysis		6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery	No
Secondary	Oxford Hip score		3yrs, 4yrs, 6yrs, 8yrs, 9yrs, 11yrs, 12yrs, 13yrs and 14yrs post-surgery	No