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

NCT03444116 | Completed

• 1 other identifier: Study 00000239
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Femoral Derotation Osteotomy; Outcomes

Outcome Measures

Primary Outcomes (3)

• Gait and Motion Analysis

  Compare gait kinematics and kinetics across groups

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

• sterEOS imaging

  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

  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 Outcomes (11)

• sterEOS imaging

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

• Number of hip abduction repetitions

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

• Seconds to complete Timed Up and Go

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

• Quality of Life as assessed by WHOQOL-bref

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

• Pain as assessed by the Brief Pain Inventory

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

Study Arms (2)

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

Motion Analysis DIAGNOSTIC_TEST

Gait and Motion Analysis, comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)

Cases (+FDO); Controls (-FDO)

sterEOS Imaging of Lower Extremities DIAGNOSTIC_TEST

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

Cases (+FDO); Controls (-FDO)

Surveys BEHAVIORAL

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

Cases (+FDO); Controls (-FDO)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Former/current patients at Gillette Children's Specialty Healthcare

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tom F Novacheck, MD

  Gillette Children's Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Orthopedic Surgeon

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 23, 2018
• Study Start: September 12, 2017
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)