Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis
Functional Outcomes for Children, Adolescents, and Young Adults With Osteonecrosis Following Hip Core Decompression
1 other identifier
observational
17
1 country
1
Brief Summary
Although uncommon in the general pediatric population, osteonecrosis (ON) is prevalent in children and adolescents with cancer, particularly among those that have had chronic exposure to glucocorticoids and among those having undergone allogeneic hematopoietic stem cell transplantation. Patients with hematologic disease are also at risk for developing ON. Hip Core Decompression (HCD) is a widely used surgical procedure with several studies reporting positive results; however, most are subject to criticism because of the limited sample size or the absence of appropriate functional outcome measures. The objective of this pilot study is to observe and collect information on several functional outcome measures and assess if Hip Core Decompression (HCD) potentially improves functional outcomes in children, adolescents and young adults with osteonecrosis. PRIMARY OBJECTIVE:
- To describe functional outcomes of children, adolescents, and young adults with osteonecrosis of the femoral head following hip core decompression surgery. Parameters assessed will include pain, functional mobility, endurance, quality of life, and gait patterns pre-operatively and post-operatively over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedStudy Start
First participant enrolled
June 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2018
CompletedNovember 13, 2018
November 1, 2018
3.3 years
May 13, 2015
November 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Degree of Pain
Pain is measured by using a numeric scale requiring patients to rate any pain experienced in the prior week on a 0 (no pain) to 10 (worst pain imaginable) scale
At 1 year after surgery
Functional Mobility
Functional mobility will be measured by using the Timed Up and Down Stairs (TUDS) and Timed Up and Go (TUG). TUDS assesses the time required for a patient to walk up and down 12 stairs to measure functional mobility, balance, and motor skills. TUG measures the time needed to stand from a seated position, ambulate 3 meters, turn around, return to chair and resume sitting. This will provide a measure of dynamic balance and mobility.
At 1 year after surgery
Physiological Cost Index (PCI)
Endurance will be assessed following completion of the 9-Minute Run-Walk Test. The patient will be instructed to walk or run for 9 minutes while trying to cover as much distance as possible. Heart rate (HR) and rate of perceived exertion (RPE) data will be collected during the walk/run. RPE measures the level of the patient's exertion using a likert scale of numbers (6-20) and adjectives describing effort. A wheeled feet counter will measure distance and a stopwatch will track time. Upon completion of the 9-minute run-walk, the physiological cost index (PCI) will be calculated by dividing the difference in the patient's heart rate (HR while walking- HR at rest) by walking speed in meters per minute.
At 1 year after surgery
Quality of Life
The use of supports, patient satisfaction, and participation in the community will be measured by patient provided responses to questions pertaining to the use of supports (brace, cane, crutches), satisfaction with walking quality, and participation in school, work, and/or sports. The responses will be scored on a 0-5 scale, with 0 demonstrating the least preferred outcome.
At 1 year after surgery
Temporo-Spatial Gait Parameters
Subjects will be required to walk at a self-selected comfortable pace and again at fast speed. Software will then calculate and report the temporo-spatial gait parameters for collection and evaluation by the primary investigator.
At 1 year after surgery
Range of Motion
Active and passive ROM will be measured using a goniometer. Measurements will include hip flexion, hip abduction and adduction, and hip internal and external rotation. ROM will be attempted on bilateral lower extremities, however if post-operative ROM precautions are implemented, the involved extremity will not be measured.
At 1 year after surgery
Study Arms (1)
Osteonecrosis
Observational measures of functional outcomes will be obtained from all participants who consent to and complete the study. Interventions: Functional Mobility Assessment (FMA), GAITRite® System, and Range of Motion.
Interventions
Functional Mobility Assessment (FMA) is a tool that was developed to measure functional mobility in children and adolescents with lower-extremity sarcoma. It is comprised of well-established outcome measures that examine various domains of function. The six categories tested by the FMA include pain, functional mobility, use of assistive devices, satisfaction with quality of gait, participation in the community, and endurance.
Subjects will be required to walk at a self-selected comfortable pace and again at fast speed. Software will then calculate and report the temporo-spatial gait parameters for collection and evaluation by the primary investigator.
Measurements will include hip flexion, hip abduction and adduction, and hip internal and external rotation. Range of motion (ROM) will be attempted on bilateral lower extremities, however if post-operative ROM precautions are implemented, the involved extremity will not be measured. Goniometry is a reliable and valid measure for active and passive ROM when following standardized procedures.
Eligibility Criteria
Participants will be patients with osteonecrosis at St. Jude Children's Research Hospital who receive hip core decompression surgery as part of their standard care.
You may qualify if:
- Patient being treated at St. Jude Children's Research Hospital
- Diagnosis of osteonecrosis of the hip
- Diagnosis of hematologic malignancy or sickle cell disease
- Age between 8 and 29 years of age
- Patient and/or parent or legal guardian must sign a written informed consent
- Patient is considered an acceptable candidate for hip core decompression surgery by his/her primary physician and orthopedic surgeon
You may not qualify if:
- Patient with a diagnosis that is not a hematologic malignancy or sickle cell disease
- Patient that has had amputation or reconstructive surgery of the lower extremities
- Premorbid condition that prevents patient from ambulating
- Patient that has a serious, non-healing wound, ulcer, or bone fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian M. DeFeo, PT, DPT
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
June 1, 2015
Study Start
June 5, 2015
Primary Completion
September 26, 2018
Study Completion
September 26, 2018
Last Updated
November 13, 2018
Record last verified: 2018-11