search
Back to results

A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing

Primary Purpose

Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Pinnacle™ Acetabular System
Pinnacle™ Acetabular System
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Hip, Cementless, Ceramic-on-Metal, Metal-on-Metal

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Skeletally mature male or female subjects, aged between 20 and 75 years inclusive at the time of surgery.
  • Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
  • 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.
  • Subjects undergoing unilateral primary total hip replacement who are suitable for a cementless acetabular component and whose femoral and acetabular bone stock is suitable to receive implants, without the requirement for a bone graft.
  • Subjects with radiographic evidence and primary diagnosis of non-inflammatory degenerative joint disease (NIDJD).
  • Subjects with a pre-operative Harris Hip Score of less than or equal to 70 and a pain rating of at least moderate for the operative hip.

Exclusion Criteria:

  • Subjects who, in the opinion of the Investigator, have an existing condition, such as active infections, highly communicable diseases, neurological or musculoskeletal disorders that might affect weight-bearing and metastatic or neoplastic disease, that would compromise their participation and follow-up in this study.
  • Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties, unless known to be titanium alloy only.
  • Patients who have received a total hip arthroplasty in the contralateral hip within the previous 12 months unless known to be titanium alloy only.
  • Subjects who have undergone previous hip surgery on the operative hip (including previous hip/surface replacements, resection arthroplasty or surgical fusion of the hip).
  • Subjects requiring a simultaneous bilateral hip operation.
  • Subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
  • Subjects with an acute femoral neck fracture of the operative hip.
  • Subjects who have undergone above knee amputation of the contralateral and/or ipsilateral leg.
  • Subjects with compromised renal function.
  • Subjects with a known allergy to metal (eg, jewellery).
  • Subjects with an occupational exposure to cobalt, chromium, molybdenum, titanium or nickel.
  • Subjects who have ingested medication or vitamins containing cobalt, chromium, molybdenum, titanium or nickel within the last 12 months, or intend to ingest such substances over the next 2 years.
  • Subjects who have undergone systemic steroid therapy, excluding inhalers, in the three months prior to surgery.
  • Women who are pregnant.
  • Subjects who are prisoners, known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical study with an investigational product in the last 12 months.
  • Subjects who are currently involved in any injury litigation claims.

Sites / Locations

  • Klinikum Garmisch-Partenkirchen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1) Ceramic-on-Metal Bearing

2) Metal-on-Metal Bearing

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cobalt metal ion levels in the blood at 2 years post surgery

Secondary Outcome Measures

Kaplan-Meier survivorship calculations
Oxford Hip Score
UCLA Score
Pain Visual Analogue Scale
Harris Hip Score
Radiographic analysis
Blood metal ion levels

Full Information

First Posted
March 19, 2009
Last Updated
May 9, 2016
Sponsor
DePuy International
search

1. Study Identification

Unique Protocol Identification Number
NCT00873444
Brief Title
A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing
Official Title
Randomised, Controlled, Prospective, Multi-Centre, Post Market Surveillance Study Comparing a Ceramic-on-Metal Bearing and a Metal-on-Metal Bearing in Subjects Requiring Primary Total Hip Arthroplasty for Non-Inflammatory Degenerative Joint Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Study progress very slow therefore terminated as other projects underway to investigate the same research question which will deliver results earlier
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. Patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis
Keywords
Hip, Cementless, Ceramic-on-Metal, Metal-on-Metal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1) Ceramic-on-Metal Bearing
Arm Type
Active Comparator
Arm Description
A cementless acetabular cup with ceramic liner for use in total hip replacement
Arm Title
2) Metal-on-Metal Bearing
Arm Type
Active Comparator
Arm Description
A cementless acetabular cup with metal liner for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
Pinnacle™ Acetabular System
Intervention Description
A cementless acetabular cup with ceramic liner for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
Pinnacle™ Acetabular System
Intervention Description
A cementless acetabular cup with metal liner for use in total hip replacement
Primary Outcome Measure Information:
Title
Cobalt metal ion levels in the blood at 2 years post surgery
Time Frame
2 years post-surgery
Secondary Outcome Measure Information:
Title
Kaplan-Meier survivorship calculations
Time Frame
Annually
Title
Oxford Hip Score
Time Frame
6 weeks, 6 months, and Annually
Title
UCLA Score
Time Frame
6 weeks, 6 months, and Annually
Title
Pain Visual Analogue Scale
Time Frame
6 weeks, 6 months, and Annually
Title
Harris Hip Score
Time Frame
6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Title
Radiographic analysis
Time Frame
6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Title
Blood metal ion levels
Time Frame
pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skeletally mature male or female subjects, aged between 20 and 75 years inclusive at the time of surgery. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. 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. Subjects undergoing unilateral primary total hip replacement who are suitable for a cementless acetabular component and whose femoral and acetabular bone stock is suitable to receive implants, without the requirement for a bone graft. Subjects with radiographic evidence and primary diagnosis of non-inflammatory degenerative joint disease (NIDJD). Subjects with a pre-operative Harris Hip Score of less than or equal to 70 and a pain rating of at least moderate for the operative hip. Exclusion Criteria: Subjects who, in the opinion of the Investigator, have an existing condition, such as active infections, highly communicable diseases, neurological or musculoskeletal disorders that might affect weight-bearing and metastatic or neoplastic disease, that would compromise their participation and follow-up in this study. Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties, unless known to be titanium alloy only. Patients who have received a total hip arthroplasty in the contralateral hip within the previous 12 months unless known to be titanium alloy only. Subjects who have undergone previous hip surgery on the operative hip (including previous hip/surface replacements, resection arthroplasty or surgical fusion of the hip). Subjects requiring a simultaneous bilateral hip operation. Subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations. Subjects with an acute femoral neck fracture of the operative hip. Subjects who have undergone above knee amputation of the contralateral and/or ipsilateral leg. Subjects with compromised renal function. Subjects with a known allergy to metal (eg, jewellery). Subjects with an occupational exposure to cobalt, chromium, molybdenum, titanium or nickel. Subjects who have ingested medication or vitamins containing cobalt, chromium, molybdenum, titanium or nickel within the last 12 months, or intend to ingest such substances over the next 2 years. Subjects who have undergone systemic steroid therapy, excluding inhalers, in the three months prior to surgery. Women who are pregnant. Subjects who are prisoners, known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. Subjects who have participated in a clinical study with an investigational product in the last 12 months. Subjects who are currently involved in any injury litigation claims.
Facility Information:
Facility Name
Klinikum Garmisch-Partenkirchen
City
Garmisch-Partenkirchen
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing

We'll reach out to this number within 24 hrs