OsteonecrosisNCT02458937
Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis
An observational study of Osteonecrosis, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 29 years
- Conditions the study is for
- Osteonecrosis
- What is being tested?
- Functional Mobility Assessment, GAITRite® System and Range of Motion
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2015to 26 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Functional Outcomes for Children, Adolescents, and Young Adults With Osteonecrosis Following Hip Core Decompression
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.
Read more
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.
Read the 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.
- Conditions
- Osteonecrosis
- Being tested
- Functional Mobility Assessment, GAITRite® System, Range of Motion
- Keywords
- Leukemia, Hodgkin Disease, Non-Hodgkin's Lymphoma, Sickle Cell Disease, Hip Core Decompression, Function Outcomes
- Medical subject headings
- Osteonecrosis, Leukemia, Hodgkin Disease, Lymphoma, Non-Hodgkin, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Mobility AssessmentOther
Also called FMA
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.
GAITRite® SystemOther
Also called Portable Walkway
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.
Range of MotionOther
Also called Goniometer, ROM
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Functional Mobility Assessment; Other: GAITRite® System; Other: Range of Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start5 Jun 2015
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tennessee Physical Therapy Association
- Responsible party
- Sponsor
- Investigators
- Brian M. DeFeo, PT, DPT, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458937
- Sponsor's protocol ID
- ONFUNC
- Status last verified
- Nov 2018
- First submitted
- 13 May 2015
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes for Children, Adolescents, and Young Adults With Osteonecrosis Following Hip Core Decompression
- ClinicalTrials.gov ID
- NCT02458937
- Acronym / sponsor ID
- ONFUNC
- Conditions
- Osteonecrosis
- Keywords
- Leukemia, Hodgkin Disease, Non-Hodgkin's Lymphoma, Sickle Cell Disease, Hip Core Decompression, Function Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Tennessee Physical Therapy Association
- Study start
- 5 Jun 2015 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteonecrosis | – | Other: Functional Mobility Assessment, Other: GAITRite® System, Other: Range of MotionObservational 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. |
Who may qualify
- Ages
- 8 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Mobility AssessmentAlso: FMAFunctional 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 | Osteonecrosis |
| GAITRite® SystemAlso: Portable WalkwaySubjects 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 | Osteonecrosis |
| Range of MotionAlso: Goniometer, ROMMeasurements 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 | Osteonecrosis |
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
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.
Temporo-Spatial Gait Parameters
Time frame: At 1 year after surgery
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.
Range of Motion
Time frame: At 1 year after surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for Osteonecrosis
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian M. DeFeo, PT, DPT principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Pain (time frame: At 1 year after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.