Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis
Condition: Osteonecrosis
MeSH terms: Osteonecrosis
Study type: Observational

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 description: 
      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.
    

Intervention name(s): Functional Mobility Assessment; GAITRite® System; Range of Motion
Intervention type(s): Other; Other; Other
Intervention description(s): 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.
Other intervention name(s): FMA; Portable Walkway; Goniometer; ROM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Keywords: Leukemia; Hodgkin Disease; Non-Hodgkin's Lymphoma; Sickle Cell Disease; Hip Core Decompression; Function Outcomes