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

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DePuy Synthes

Status and phase

Terminated
Phase 4

Conditions

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

Treatments

Device: Pinnacle™ Acetabular System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00873444
CT00/37

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

1) Ceramic-on-Metal Bearing
Active Comparator group
Description:
A cementless acetabular cup with ceramic liner for use in total hip replacement
Treatment:
Device: Pinnacle™ Acetabular System
2) Metal-on-Metal Bearing
Active Comparator group
Description:
A cementless acetabular cup with metal liner for use in total hip replacement
Treatment:
Device: Pinnacle™ Acetabular System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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