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CompletedNCT03444116Updated Feb 10, 2021

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

An observational study in Cerebral Palsy, Femoral Derotation Osteotomy and Outcomes, sponsored by Gillette Children's Specialty Healthcare. Completed at 1 site in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Gillette Children's Specialty Healthcare · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
62
Ages
25 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy
  • Femoral Derotation Osteotomy
  • Outcomes

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03

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Former/current patients at Gillette Children's Specialty Healthcare

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

Exclusion Criteria:

  • none
04

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
62 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases (+FDO)

    Patients who underwent an FDO

    Diagnostic Test: Motion Analysis · Diagnostic Test: sterEOS Imaging of Lower Extremities · Behavioral: Surveys

  • Controls (-FDO)

    Same as cases but did not undergo an FDO

    Diagnostic Test: Motion Analysis · Diagnostic Test: sterEOS Imaging of Lower Extremities · Behavioral: Surveys

Interventions

  • Diagnostic testMotion 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 teststerEOS Imaging of Lower Extremities

    Bi-planar imaging of the lower extremities to evaluate femoral anteversion and hip dysplasia and subluxation.

  • BehavioralSurveys

    9 surveys assessing function, activity, participation, pain, quality of life, and treatment history.

05

What researchers measure

Primary outcomes

  1. Gait and Motion Analysis

    Compare gait kinematics and kinetics across groups

    Time frame: long-term research visit (on average, ~10 years post-baseline)

  2. sterEOS imaging

    femoral anteversion determined by 3-D reconstruction of bi-planar sterEOS imaging

    Time frame: long-term research visit (on average, ~10 years post-baseline)

  3. Change in Gait and Motion Analysis

    Compare change in gait kinematics and kinetics within groups

    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)

Secondary outcomes

  1. sterEOS imaging

    Assess hip dysplasia and/or subluxation in qualifying limb across groups

    Time frame: long-term research visit (on average, ~10 years post-baseline)

  2. Number of hip abduction repetitions

    Assess hip function across groups

    Time frame: long-term research visit (on average, ~10 years post-baseline)

  3. Seconds to complete Timed Up and Go

    Assess function across groups

    Time frame: long-term research visit (on average, ~10 years post-baseline)

  4. Quality of Life as assessed by WHOQOL-bref

    self-reported survey

    Time frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

  5. Pain as assessed by the Brief Pain Inventory

    self-reported survey

    Time frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

  6. Fear of Falling as assessed by Falls Efficacy Scale-International

    self-reported survey

    Time frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

  7. Hip Function as assessed by Harris Hip Function

    self-reported survey

    Time frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

  8. General Function as assessed by Functional Assessment Questionnaire

    self-reported survey

    Time frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

  9. Walking Function as assessed by Function Mobility Scale

    self-reported survey

    Time frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

  10. Participation as assessed by Child/Adolescent Frequency of Participation Questionnaire

    self-reported survey

    Time frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

  11. Satisfaction with Life as assessed by Deiner Satisfaction with Life Scale

    self-reported survey

    Time frame: compare scores across groups at long-term research visit (on average, ~10 years post-baseline)

06

Study locations

1 site
  • Gillette Children's Specialty Healthcare
    Saint Paul, Minnesota 55101, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03444116
Lead sponsor
Gillette Children's Specialty Healthcare
Responsible party
Tom F Novacheck (Pediatric Orthopedic Surgeon, Gillette Children's Specialty Healthcare) — Principal investigator
First posted
Feb 23, 2018
Start date
Sep 12, 2017
Primary completion
Nov 15, 2019
Completion
Nov 15, 2019
Last update
Feb 10, 2021

Study contacts

Tom F Novacheck, MD
principal investigator · Gillette Children's Specialty Healthcare

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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