Birmingham Hip Resurfacing (BHR) Study: Implantation of a... | NCT00180206

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

NCT00180206

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Jan 16, 2006Estimated

Enrollment

300

Phase

Phase 4

Conditions

Arthritis

Interventions

Birmingham Hip Resurfacing

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Dec 2008

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2006

Last Update Posted Date

Jan 16, 2006Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
Birmingham Hip Resurfacing	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional result
Radiological result
Subjective patient outcome

Secondary Outcomes

Measure	Description	Time Frame
Perioperative and postoperative complication rate
Revision rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wolf-Christoph Witzleb, MD	Contact	+49 (0)351 4583323		Wolf-Christoph.Witzleb@uniklinikum-dresden.de

Overall Officials

Name	Affiliation	Role
Klaus-Peter Guenther, Prof.	Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopaedic Surgery, University Hospital, Technical University of Dresden	Recruiting	Dresden		01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided