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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Tennessee Orthopedic Alliance.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738803
First Posted: August 20, 2008
Last Update Posted: February 6, 2009
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.
Information provided by:
Tennessee Orthopedic Alliance
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoration of Leg Length, Offset, and Center of Rotation in Total Hip Replacement

Resource links provided by NLM:


Further study details as provided by Tennessee Orthopedic Alliance:

Primary Outcome Measures:
  • Leg Length and total offset [ Time Frame: 2 weeks ]

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
Experimental: 1
Leg Length and offset measurement arm
Procedure: Total hip replacement
Total hip replacement typically preformed for hip arthritis
Other Name: Measurement Arm

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: William B Kurtz, Tennessee Orthopedic Alliance
ClinicalTrials.gov Identifier: NCT00738803     History of Changes
Other Study ID Numbers: 2615
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: February 6, 2009
Last Verified: February 2009

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