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

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.