Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis

NCT02458937 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2018-11-13

No results posted yet for this study

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.

Conditions

  • Osteonecrosis

Interventions

OTHER

Functional Mobility Assessment

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.

OTHER

GAITRite® System

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.

OTHER

Range of Motion

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.

Sponsors & Collaborators

Principal Investigators

  • Brian M. DeFeo, PT, DPT · St. Jude Children's Research Hospital

Eligibility

Min Age
8 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-05
Primary Completion
2018-09-26
Completion
2018-09-26

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02458937 on ClinicalTrials.gov