deltatrials
Completed OBSERVATIONAL NCT03444116

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

Sponsor: Gillette Children's Specialty Healthcare

Updated 10 times since 2018 Last updated: Feb 9, 2021 Started: Sep 12, 2017 Primary completion: Nov 15, 2019 Completion: Nov 15, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03444116, this observational or N/A phase trial focuses on Cerebral Palsy and Femoral Derotation Osteotomy and remains completed. Sponsored by Gillette Children's Specialty Healthcare, it has been updated 10 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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...

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.

Status Flow

~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshotEnrolling By Invitation~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotEnrolling By Invitation~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshotEnrolling By Invitation~Aug 2018 – ~Mar 2020 · 19 months · monthly snapshotEnrolling By Invitation~Mar 2020 – ~Aug 2020 · 5 months · monthly snapshotActive Not Recruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotActive Not Recruiting~Mar 2021 – ~Jul 2024 · 40 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Mar 2021 — Jul 2024 [monthly]

    Completed

    Status: Active Not RecruitingCompleted

  4. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting

  5. Aug 2020 — Jan 2021 [monthly]

    Active Not Recruiting

Show 5 earlier versions
  1. Mar 2020 — Aug 2020 [monthly]

    Active Not Recruiting

    Status: Enrolling By InvitationActive Not Recruiting

  2. Aug 2018 — Mar 2020 [monthly]

    Enrolling By Invitation

  3. Jun 2018 — Aug 2018 [monthly]

    Enrolling By Invitation

  4. Apr 2018 — Jun 2018 [monthly]

    Enrolling By Invitation

    Phase: NANone

  5. Mar 2018 — Apr 2018 [monthly]

    Enrolling By Invitation NA

    First recorded

Sep 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gillette Children's Specialty Healthcare
Data source: Gillette Children's Specialty Healthcare

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations