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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00873444
Other study ID # CT00/37
Secondary ID
Status Terminated
Phase Phase 4
First received March 19, 2009
Last updated May 9, 2016
Start date July 2006
Est. completion date November 2006

Study information

Verified date March 2016
Source DePuy International
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Pinnacle™ Acetabular System
A cementless acetabular cup with ceramic liner for use in total hip replacement
Pinnacle™ Acetabular System
A cementless acetabular cup with metal liner for use in total hip replacement

Locations

Country Name City State
Germany Klinikum Garmisch-Partenkirchen Garmisch-Partenkirchen

Sponsors (1)

Lead Sponsor Collaborator
DePuy International

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cobalt metal ion levels in the blood at 2 years post surgery 2 years post-surgery No
Secondary Kaplan-Meier survivorship calculations Annually Yes
Secondary Oxford Hip Score 6 weeks, 6 months, and Annually No
Secondary UCLA Score 6 weeks, 6 months, and Annually No
Secondary Pain Visual Analogue Scale 6 weeks, 6 months, and Annually Yes
Secondary Harris Hip Score 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery No
Secondary Radiographic analysis 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery No
Secondary Blood metal ion levels pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery No
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