Long-Term Outcomes of Femoral Derotation Osteotomy for Individuals With Cerebral Palsy

February 9, 2021 updated by: Tom F Novacheck, Gillette Children's Specialty Healthcare
Excessive anteversion is commonly observed in the cerebral palsy (CP) population. This can be treated by an orthopedic surgery, called femoral derotation osteotomy (FDO), to de-rotate the femur. It is a vital aspect of patient care to understand if the effects of an FDO are maintained long-term. The results of this study will have direct clinical impact by equipping providers with the necessary information to counsel families by providing families the information needed to make the most informed decision possible about this aspect of their child's healthcare.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Excessive anteversion is commonly observed in the CP population. If individuals do not internally rotate their femurs as a compensation for this bony torsion, excessive anteversion decreases the coronal plane moment arm of the hip abductors-a phenomenon often called lever arm dysfunction. Considering that adequate hip abductor strength is a crucial factor for normal walking and many other functional activities, the compensatory mechanism theory hypothesizes that individuals with excessive anteversion will internally rotate their hips to restore the coronal plane moment arms. Excessive internal hip rotation (IHR) is observed in the gait of approximately 50% of individuals with CP. It has been postulated, though, that while IHR may restore hip abductor function, it is cosmetically unappealing and may lead to trips and falls. Therefore, FDOs are considered the standard treatment for correcting excessive anteversion and IHR in individuals with CP. Notably, it is one of the top two orthopedic surgeries performed at Gillette Children's Specialty Healthcare. Among the ~4000 individuals with CP who have been seen in the gait lab, almost 1350 individuals (>2200 limbs) have undergone at least one FDO.

Short-term (~12 months postoperative) improvements of transverse plane hip rotation during gait range from only 33% to 94%. Despite FDO's widespread use, long-term outcomes of the procedure have only begun to be studied, with our 2016 study the only one that included a control group. Without a control group, the natural history of bony remodeling or gait adaptations is unknown. However, our prior study is limited by two main factors, 1) all data were extracted from our database retrospectively, so the potential for a large bias exists since outcomes reflect only patients with clinically-initiated gait visits, and 2) outcomes of hip abductor function were only measured by hip rotation (or hip abductor moment during gait, which is only available for individuals who can walk without assistive devices), so the true ability of the hip abductors to generate moment has not been tested. Furthermore, the vast majority of individuals were <18 years old at their "long-term" visit (~5 years after their preoperative gait visit), which precedes the reported gait or functional decline more commonly occurring in one's 20s and beyond.

Counseling families on the long-term outcomes after an FDO is currently not possible and is necessary for families and health-care providers to make informed decisions. It remains unclear whether individuals who receive an FDO experience long-term beneficial effects on function, activity, and comfort as compared to those who receive other or no treatment for their excessive anteversion and/or IHR.

Briefly, anteversion as measured by the trochanteric prominence angle test (TPAT) is the most common method used by clinicians to determine if an FDO is warranted, in addition to anteversion being an important predictor of predicted short-term outcomes after an FDO23. However, data from our lab suggests that there is 10-15° of measurement error associated with this method. As such, our secondary purpose was to compare anteversion as measured by the TPAT to that of a radiographical gold standard, EOS. EOS delivers 4-30 times less radiation to the gonads and lower extremities compared to computed tomography (CT)24, making it very suitable for research purposes. Additionally, accuracy of quantifying femoral anteversion is not compromised versus the current gold standard, CT, with a mean difference of ~3° reported.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Gillette Children's Specialty Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Former/current patients at Gillette Children's Specialty Healthcare

Description

Inclusion Criteria:

  • Diagnosed with bilateral CP (i.e., hemiplegics excluded)
  • Minimum age of 25 years presently
  • Had a preoperative gait analysis
  • Underwent only 1 external, proximal FDO per side
  • Minimum 5 years since an FDO
  • FDO implants have been removed
  • No prior pelvic osteotomy
  • Able to speak and read English
  • Not pregnant

Control group (-FDO):

  • Same as cases, except no FDO
  • Matched to cases at baseline (using a matching algorithm)

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cases (+FDO)
Patients who underwent an FDO
Diagnostic test: Motion Analysis
Gait and Motion Analysis, comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)
Diagnostic test: sterEOS Imaging of Lower Extremities
Bi-planar imaging of the lower extremities to evaluate femoral anteversion and hip dysplasia and subluxation.
Behavioral: Surveys
9 surveys assessing function, activity, participation, pain, quality of life, and treatment history.
Controls (-FDO)
Same as cases but did not undergo an FDO
Diagnostic test: Motion Analysis
Gait and Motion Analysis, comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)
Diagnostic test: sterEOS Imaging of Lower Extremities
Bi-planar imaging of the lower extremities to evaluate femoral anteversion and hip dysplasia and subluxation.
Behavioral: Surveys
9 surveys assessing function, activity, participation, pain, quality of life, and treatment history.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gait and Motion Analysis
Time Frame: long-term research visit (on average, ~10 years post-baseline)
Compare gait kinematics and kinetics across groups
long-term research visit (on average, ~10 years post-baseline)
sterEOS imaging
Time Frame: long-term research visit (on average, ~10 years post-baseline)
femoral anteversion determined by 3-D reconstruction of bi-planar sterEOS imaging
long-term research visit (on average, ~10 years post-baseline)
Change in Gait and Motion Analysis
Time Frame: baseline (qualifying exam, pre-FDO or gait analysis at which controls matched cases) compared to long-term research visit (on average, ~10 years post-baseline)
Compare change in gait kinematics and kinetics within groups
baseline (qualifying exam, pre-FDO or gait analysis at which controls matched cases) compared to long-term research visit (on average, ~10 years post-baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sterEOS imaging
Time Frame: long-term research visit (on average, ~10 years post-baseline)
Assess hip dysplasia and/or subluxation in qualifying limb across groups
long-term research visit (on average, ~10 years post-baseline)
Number of hip abduction repetitions
Time Frame: long-term research visit (on average, ~10 years post-baseline)
Assess hip function across groups
long-term research visit (on average, ~10 years post-baseline)
Seconds to complete Timed Up and Go
Time Frame: long-term research visit (on average, ~10 years post-baseline)
Assess function across groups
long-term research visit (on average, ~10 years post-baseline)
Quality of Life as assessed by WHOQOL-bref
Time Frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
self-reported survey
compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
Pain as assessed by the Brief Pain Inventory
Time Frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
self-reported survey
compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
Fear of Falling as assessed by Falls Efficacy Scale-International
Time Frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
self-reported survey
compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
Hip Function as assessed by Harris Hip Function
Time Frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
self-reported survey
compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
General Function as assessed by Functional Assessment Questionnaire
Time Frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
self-reported survey
compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
Walking Function as assessed by Function Mobility Scale
Time Frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
self-reported survey
compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
Participation as assessed by Child/Adolescent Frequency of Participation Questionnaire
Time Frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
self-reported survey
compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
Satisfaction with Life as assessed by Deiner Satisfaction with Life Scale
Time Frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)
self-reported survey
compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gillette Children's Specialty Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tom F Novacheck, MD, Gillette Children's Specialty Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Study 00000239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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