Clinical Trial: Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Functional Outcomes for Children, Adolescents, and Young Adults With Osteonecrosis Following Hip Core Decompression
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.
Detailed Summary:
Hip core decompression (HCD) is not being done as part of this study. Rather, patients who are undergoing HCD at St. Jude Children's Research Hospital (SJCRH) will be observed for functional outcomes following the procedure.
HCD is considered an excellent surgical option when considering the multiple issues among this population, which include young age, the natural progression of osteonecrosis to femoral head collapse, the limited life expectancy of the prosthetic technology currently available for total hip arthroplasty (THA), and patient quality of life. This study will seek to describe functional outcomes and quality of gait following HCD in a pediatric population with osteonecrosis. The results of this study will provide valuable information as to the functional limitations within this population pre- and post-operatively.
For each research participant the observations on all outcome measures of interest will be collected at 5 time points: pre-operatively (baseline measure), and post-operatively at 6 weeks, 12 weeks, 6 months and 1 year. These time points will allow for comparison between pre- and post-operative outcomes to determine if outcomes are improved following surgery, and if these outcomes continue to improve over time. This study will also provide a foundation for the future development of treatment programs designed to target identified limitations specific to this population.
Sponsor: St. Jude Children's Research Hospital
Current Primary Outcome:
- Degree of Pain [ Time Frame: At 1 year after surgery ]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
- Functional Mobility [ Time Frame: At 1 year after surgery ]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.
- Physiological Cost Index (PCI) [ Time Frame: At 1 year after surgery ]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.
- Quality of Life [ Time Frame: At 1 year after surgery ]
- Degree of Pain [ Time Frame: At 1 year after surgery ]
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- Functional Mobility [ Time Frame: At 1 year after surgyer ]
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.- Physiological Cost Index (PCI) [ Time Frame: At 1 year after surgery ]
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.- Quality of Life [ Time Frame: At 1 year after surgery ]
- Degree of Pain [ Time Frame: At 1 year after surgery ]