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ArthritisNCT00738803

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

A study testing Total hip replacement in people with Arthritis, run by Tennessee Orthopedic Alliance at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Arthritis
What is being tested?
Total hip replacement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
Jun 2007to Apr 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

William Kurtz, MD contact

615-963-1437

kurtzwb@tnortho.com

United States1 site, 1 recruiting
  • Baptist Hospital

    Nashville, Tennessee, 37203

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Background:

Leg length inequality following total hip replacement is the leading cause of patient dissatisfaction and subsequent litigation after total hip replacement. A change in the total offset of the hip (lateral translation of the femur relative to the pelvis) may also cause significant discomfort and hip instability. Before surgery, patients are informed that their leg may be lengthened and a shoe lift may be required in the opposite shoe to equalize the leg lengths. Although much less frequent, the leg can accidentally be shortened following total hip replacement. In one recent study, 62% of patients had a mean leg lengthening of 9 mm and one third of these patients complained about this lengthening.

Limb length inequality can occur for two reasons. First, significant inaccuracies exist in current leg length measurement techniques. Second, the surgeon may deliberately lengthen a patient in order to gain hip stability. Increasing leg length and/or hip offset decreases the occurrence of bony impingement and increases myofascial tension, both of which improve hip stability and prevent hip dislocation.

Current methods of determining leg length and offset during surgery include pre-operative templating, intra-operative measurements, intra-operative x-rays, and computer navigated surgery. From the pre-operative x-rays, surgeons typically determine which size implant will best fit the patient's anatomy and best recreate the same leg length. During surgery, surgeons may attempt to palpate both the operative and the contra-lateral knee and/or ankle to estimate leg lengths. Surgeons may measure the length of the femoral head and neck that were removed and the length of the femoral head and neck that were replaced. Surgeons may insert a long pin into the pelvis (typically the ilium bone) and measure the length from this pin to some reference point on the femur. This pin in the pelvis method is probably considered the most accurate, but the leg must be repositioned in exactly the same position for the measurement to be accurate; 5° of hip abduction results in an 8 mm error in leg length.3 An intra-operative x-ray that shows both hips can also help estimate leg length and hip offset. Surgical navigation can determine leg length but is not widely availability and requires a significant financial commitment by an institution. Surgeons typically determine the appropriate amount of hip offset from their pre-operative templating. Current leg length guides have shown even greater errors in their attempts to measure hip offset.

Hypothesis:

We 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. We plan to evaluate the clinical outcome of this procedure and compare it to historical controls.

Goals:

Our primary goal of this research study is to accurately measure and restore the leg length during a hip replacement. Our second goal is to accurately measure and restore the hip offset.

Endpoints:

Patients will be evaluated in clinic at 2 weeks, 3 months, one year, two year, five years and every 5 years afterwards. The leg length, offset and center of rotation will be measured on the pre and post-operative x-ray. Questionnaires based on validated clinical outcomes scores will be completed at the pre-operative visit, at 3 months, one year, two years, five years and every 5 years afterwards.

Abbreviated Methods:

Patients who consent for enrollment in this study will have a standard pre-operative and post-operative AP pelvic x-ray, and leg length, offset measurements, and center of rotation measurements will be made from these two radiographs. In addition, intra-operative fluoroscopic radiographs will also be obtained. Validated questionnaire (Harris Hip Scores) will be administered pre-operatively, at 3 months, at one year, and at two years.

The operative technique for measuring leg length 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 first measurements of leg length and offset are recorded. The reference guide is removed from the femoral component and the femoral neck osteotomy is performed. The native femoral head is removed and measured. The acetabulum is prepared and the acetabular component is inserted. A repeat measurement with trial components in place allows the surgeon an additional opportunity to accurately recreate leg length and offset with the final component. After the final components are inserted, the reference screw is removed from the ilium and the incision is closed. All total hips in this study will be performed through a superior approach so that the anterior and posterior capsules are preserved and hip stability is maximized. This capsular tissue preservation approach will prevent or at least limit the need to deliberately lengthen the leg in order to gain hip stability.

Conditions
Arthritis
Being tested
Total hip replacement
Keywords
leg length, hip arthroplasty, offset
Medical subject headings
Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total hip replacementProcedure or surgery

    Also called Measurement Arm

    Total hip replacement typically preformed for hip arthritis

Study groups in NCT00738803
Study groupRoleWhat they receive
1ExperimentalLeg Length and offset measurement arm
Receives: Procedure: Total hip replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Leg Length and total offset

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionApr 2009 (estimated)
  4. Study completionApr 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00738803
Sponsor's protocol ID
2615
Status last verified
Feb 2009
First submitted
18 Aug 2008
Last updated
6 Feb 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16394166
  • 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.

    PubMed 15736733
  • 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.

    PubMed 16230240

Questions about this trial

What is this clinical trial studying?

A study testing Total hip replacement in people with Arthritis, run by Tennessee Orthopedic Alliance at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact William Kurtz, MD (615-963-1437, kurtzwb@tnortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leg Length and total offset (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00738803, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2009.

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