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Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis

NCT ID: NCT00180206

Last Updated: 2006-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is the investigation of the functional and radiological results and subjective patient outcome after the implantation of a hip resurfacing endoprosthesis (Birmingham hip resurfacing).

Detailed Description

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High volumetric wear of polyethylene was the main factor in periprosthetic bone resorption and failure of historic hip resurfacing prosthesis. Metal-on-metal devices reduce the wear substantially and may solve this problem. The purpose of this study is the investigation of the functional and radiological result and subjective patient outcome after implantation of a hip resurfacing endoprosthesis (Birmingham Hip Resurfacing) during the first two years after surgery.

Conditions

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Arthritis

Keywords

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Arthritis Hip Hip arthroplasty Hip resurfacing arthroplasty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Birmingham Hip Resurfacing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical and radiological signs of coxarthritis
* Implantation of a total hip replacement indicated
* Informed consent

Exclusion Criteria

* Osteoporosis
* Tumor
* Acute infection
* Higher grade congenital dysplasia of the hip
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Principal Investigators

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Klaus-Peter Guenther, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden

Locations

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Department of Orthopaedic Surgery, University Hospital, Technical University of Dresden

Dresden, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Wolf-Christoph Witzleb, MD

Role: CONTACT

Phone: +49 (0)351 4583323

Email: [email protected]

Facility Contacts

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Wolf-Christoph Witzleb, MD

Role: primary

Other Identifiers

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DresdenU

Identifier Type: -

Identifier Source: org_study_id