NCT00180206

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 16, 2006

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

January 13, 2006

Conditions

Arthritis

Keywords

ArthritisHipHip arthroplastyHip resurfacing arthroplasty

Outcome Measures

Primary Outcomes (3)

  • Functional result

  • Radiological result

  • Subjective patient outcome

Secondary Outcomes (2)

  • Perioperative and postoperative complication rate

  • Revision rate

Interventions

Birmingham Hip ResurfacingDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Osteoporosis
  • Tumor
  • Acute infection
  • Higher grade congenital dysplasia of the hip
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Klaus-Peter Guenther, Prof.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolf-Christoph Witzleb, MD

CONTACT

+49 (0)351 4583323Wolf-Christoph.Witzleb@uniklinikum-dresden.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

January 1, 2005

Study Completion

December 1, 2008

Last Updated

January 16, 2006

Record last verified: 2005-09

Locations

DE(1)