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Restoration of Leg Length, Offset, and Center of Rotation in Total Hip Replacement

This study is currently recruiting participants.
Verified by Tennessee Orthopedic Alliance, August 2008

Sponsored by: Tennessee Orthopedic Alliance
Information provided by: Tennessee Orthopedic Alliance
ClinicalTrials.gov Identifier: NCT00738803
  Purpose

The investigators aim to demonstrate the ability to accurately measure and restore leg length, offset, and center of rotation during a total hip replacement through a new technique that uses the femoral component as a measurement tool. The operative technique requires inserting the femoral component prior to performing the femoral neck osteotomy. After the femoral component is implanted, a reference guide is attached to the femoral component and guides a screw into the ilium at a fixed distance from the femoral component. The pre-arthroplasty measurements of leg length and offset are recorded. The femoral neck osteotomy is performed, and the native femoral head is removed and measured. The acetabular socket is prepared and the acetabular component is inserted. A repeat measurement with trial modular neck components is taken and allows the surgeon an additional opportunity to accurately recreate leg length and offset with the final component. The reference screw is removed from the ilium and the incision is closed.


Condition Intervention
Arthritis
Procedure: Total hip replacement

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:   Restoration of Leg Length, Offset, and Center of Rotation in Total Hip Replacement

Further study details as provided by Tennessee Orthopedic Alliance:

Primary Outcome Measures:
  • Leg Length and total offset [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   June 2007
Estimated Study Completion Date:   April 2010
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Leg Length and offset measurement arm
Procedure: Total hip replacement
Total hip replacement typically preformed for hip arthritis

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Hip arthritis requiring a total hip replacement through a superior approach

Exclusion Criteria:

  • Non-english speaking
  • Need for a cemented femoral stem
  • Acute femoral neck fracture
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738803

Contacts
Contact: William Kurtz, MD     615-963-1437     kurtzwb@tnortho.com    

Locations
United States, Tennessee
Baptist Hospital     Recruiting
      Nashville, Tennessee, United States, 37203

Sponsors and Collaborators
Tennessee Orthopedic Alliance

Investigators
Principal Investigator:     William B Kurtz, MD     Tennessee Orthopedic Alliance    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   Tennessee Orthopedic Alliance ( William B Kurtz )
Study ID Numbers:   2615
First Received:   August 18, 2008
Last Updated:   August 19, 2008
ClinicalTrials.gov Identifier:   NCT00738803
Health Authority:   United States: Institutional Review Board

Keywords provided by Tennessee Orthopedic Alliance:
leg length  
hip arthroplasty  
offset  

Study placed in the following topic categories:
Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on October 15, 2008




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