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

NCT00873444 | Terminated Phase 4

• 1 other identifier: CT00/37
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Keywords

Hip; Cementless; Ceramic-on-Metal; Metal-on-Metal

Outcome Measures

Primary Outcomes (1)

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

  2 years post-surgery

Secondary Outcomes (7)

• Kaplan-Meier survivorship calculations

  Annually

• Oxford Hip Score

  6 weeks, 6 months, and Annually

• UCLA Score

  6 weeks, 6 months, and Annually

• Pain Visual Analogue Scale

  6 weeks, 6 months, and Annually

• Harris Hip Score

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

Study Arms (2)

1) Ceramic-on-Metal Bearing

ACTIVE COMPARATOR

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

Device: Pinnacle™ Acetabular System

2) Metal-on-Metal Bearing

ACTIVE COMPARATOR

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

Device: Pinnacle™ Acetabular System

Interventions

Pinnacle™ Acetabular System DEVICE

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

1) Ceramic-on-Metal Bearing

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany

Location

MeSH Terms

Conditions

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; 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: April 1, 2009
• Study Start: July 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: May 11, 2016

Record last verified: 2016-03

Locations

DE (1)