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

NCT00872222 | Terminated Phase 4

• 1 other identifier: CT03/39
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis; Traumatic Femoral Fractures

Keywords

Hip; Cementless; Ceramic-on-Ceramic

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier survivorship at the five-year period

  5yrs

Secondary Outcomes (4)

• Kaplan-Meier survivorship calculations

  Annually

• Harris Hip Score

  6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery

• Radiographic analysis

  6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery

• Oxford Hip score

  3yrs, 4yrs, 6yrs, 8yrs, 9yrs, 11yrs, 12yrs, 13yrs and 14yrs post-surgery

Study Arms (1)

Ceramic-on-Ceramic

OTHER

Pinnacle™ Acetabular System with ceramic liner

Device: Pinnacle™ Acetabular System

Interventions

Pinnacle™ Acetabular System DEVICE

A cementless acetabular cup with ceramic liner for use in total hip replacement

Ceramic-on-Ceramic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

St Anne's University Hospital

Brno, Czechia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: January 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 7, 2016

Record last verified: 2016-09

Locations

CZ (1)