Clinical trial NCT02458937: Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis
Official title: Functional Outcomes for Children, Adolescents, and Young Adults With Osteonecrosis Following Hip Core Decompression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteonecrosis
Keywords: Leukemia
Hodgkin Disease
Non-Hodgkin's Lymphoma
Sickle Cell Disease
Hip Core Decompression
Function Outcomes
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Tennessee Physical Therapy Association
First posted: 2015-06-01
Enrollment: 17
Sex: ALL
Minimum age (years): 8
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Degree of Pain
timeFrame: At 1 year after surgery
measure: Functional Mobility
timeFrame: At 1 year after surgery
measure: Physiological Cost Index (PCI)
timeFrame: At 1 year after surgery
measure: Quality of Life
timeFrame: At 1 year after surgery
measure: Temporo-Spatial Gait Parameters
timeFrame: At 1 year after surgery
measure: Range of Motion
timeFrame: At 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Brian M. DeFeo, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: