Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02391129
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Julian Joestl, Medical University of Vienna

Brief Summary:
The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C periprosthetic fracture after primary total hip replacement.

Condition or disease Intervention/treatment
Periprosthetic Fractures Procedure: Operation for Periprosthetic fractures of the hip with stem loosening

Layout table for study information
Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hyperion Prosthesis
Patients treated with the second generation long-stem revision prosthesis
Procedure: Operation for Periprosthetic fractures of the hip with stem loosening
Helios Prosthesis
Patients treated with the first generation long-stem revision prosthesis
Procedure: Operation for Periprosthetic fractures of the hip with stem loosening
Locking compression plate
Patients treated with LCP
Procedure: Operation for Periprosthetic fractures of the hip with stem loosening



Primary Outcome Measures :
  1. Clinical Outcome (Range of Motion of the hip) [ Time Frame: follow up of at least 1 year ]
    Range of Motion of the hip

  2. Radiographic Outcome (boney consolidation of the fracture) [ Time Frame: follow up of at least 1 year ]
    boney consolidation of the fracture after 3 month, 6 month and at least 1 year after the operation


Secondary Outcome Measures :
  1. Patient's Mobility (assessed by the Parker's Mobility Score) [ Time Frame: follow up of at least 1 year ]
    Patient's Mobility assessed by the Parker's Mobility Score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We retrospectively reviewed a consecutive series of 102 patients with Vancouver type-B2, B3 and C periprosthetic fractures and unstable femoral stem, which had been prospectively entered, in our hip-trauma database.
Criteria

Inclusion Criteria:

  • Patients with Vancouver type- BlI, BIII and C fractures and unstable femoral prosthesis stem.

Exclusion Criteria:

  • Patients with pathological fractures,
  • Vancouver type-A, Bl, and
  • stable femoral prosthesis stem,
  • Patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.

Layout table for additonal information
Responsible Party: Julian Joestl, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02391129     History of Changes
Other Study ID Numbers: 1674/2014
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Femoral Fractures
Periprosthetic Fractures
Wounds and Injuries
Leg Injuries