NCT00738803

Brief Summary

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.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

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

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

1.8 years

First QC Date

August 18, 2008

Last Update Submit

February 5, 2009

Conditions

Keywords

leg lengthhip arthroplastyoffset

Outcome Measures

Primary Outcomes (1)

  • Leg Length and total offset

    2 weeks

Study Arms (1)

1

EXPERIMENTAL

Leg Length and offset measurement arm

Procedure: Total hip replacement

Interventions

Total hip replacement typically preformed for hip arthritis

Also known as: Measurement Arm
1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baptist Hospital

Nashville, Tennessee, 37203, United States

RECRUITING

Related Publications (3)

  • Clark CR, Huddleston HD, Schoch EP 3rd, Thomas BJ. Leg-length discrepancy after total hip arthroplasty. J Am Acad Orthop Surg. 2006 Jan;14(1):38-45. doi: 10.5435/00124635-200601000-00007.

    PMID: 16394166BACKGROUND
  • Konyves A, Bannister GC. The importance of leg length discrepancy after total hip arthroplasty. J Bone Joint Surg Br. 2005 Feb;87(2):155-7. doi: 10.1302/0301-620x.87b2.14878.

    PMID: 15736733BACKGROUND
  • Sarin VK, Pratt WR, Bradley GW. Accurate femur repositioning is critical during intraoperative total hip arthroplasty length and offset assessment. J Arthroplasty. 2005 Oct;20(7):887-91. doi: 10.1016/j.arth.2004.07.001.

    PMID: 16230240BACKGROUND

MeSH Terms

Conditions

Arthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • William B Kurtz, MD

    Tennessee Orthopedic Alliance

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William Kurtz, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

June 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2010

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations