Spinal FusionADLNCT04037059
Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL)
An observational study of Spinal Fusion and Activities of Daily Living Following Complex Spinal Fusions, run by Duke University at 1 site in United States.
Trial summary
This study is being done to assess the impact of arm length and abdominal (belly) width on patient performance of daily self-care activities following multiple level spinal fusions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Fusion, Activities of Daily Living Following Complex Spinal Fusions
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2019to 31 Mar 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are seeking evaluation and treatment at the Duke Spine Center and have been recommended to undergo spine surgery will be approached by the treating surgeon and/or the study coordinator about the study. The goal enrollment is 256 patients within 1 year.
Who may be able to join
- Adults18 to 80 years old
- Spinal fusion surgery involving thoracolumbar spine > 5 levels
- Ability to stand to obtain arm span, abdominal girth and ability to bend at the waist to obtain measurement
Who cannot join
- Patients who are incarcerated, paraplegic or unable to return for follow-up visits
- Patients with prior lumbar fusions at the indicated levels for surgery
- Spinal fusion surgery involving thoracolumbar < 5 levels
- Patients who already have lumbopelvic fixation with iliac screws
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL) in Patients Undergoing Long Segment Deformity Surgery: A Prospective Study
This study is being done to assess the impact of arm length and abdominal (belly) width on patient performance of daily self-care activities following multiple level spinal fusions. The study will also assess if the number of levels operated on in the spinal fusion procedure affects your ability to perform Activities of Daily Living (ADL) and how long after surgery do the difficulties/limitations persist.
Read the detailed description
This is a prospective, single-center study of adult patients undergoing long segment spinal fusions to the pelvis (>5 levels).
Health Related Quality of Life Outcome (HRQOL) consisting of the Oswestry Disability Index (ODI), Visual Analog Scale, EQ-5D, Scoliosis Research Society-22 and 30 (SRS-22 and SRS-30) and the Lumbar Stiffness Disability Index (LSDI) will be collected preoperatively, 6 weeks, 3 months, 6 months, 12 and 24 months. All measures will be collected during clinic visits.
Primary and secondary objectives The primary objective is to determine the impact of body habitus on postoperative ADLs in patients undergoing long segment spinal fusions.
The secondary objective will be to determine if the number of levels of fusions impact the ability to perform ADLs and to study how long after surgery do the difficulties/limitations persist.
Study procedures Enrolled subjects meeting eligibility criteria and provide consent will be approached by the study coordinator and explained the purpose of the study, risks and benefits to participation, and queried about their interest in participation. Patients consenting to the study will have the following measurements performed by the clinician with an evaluation prior to surgery, during their 6 week, 3 month, 6 month, 12 and 24 month postoperative visits.
- Waist circumference using a measuring tape will be obtained from midway between the last ribs and the iliac crest as suggested by the World Health Organization and the International Diabetes Federation.
- The arm span (wingspan) or reach will be measured. To measure the arm span, the patient will be asked to stand against the wall with their arms extended sideways at a ninety-degree angle. Using a measuring tape, the distance from the tip of the middle finger of one hand to the tip of the middle finger in other arm will be measured and recorded.
- The distance from the ground to the tip of middle finger will be measured while the patient is asked to touch their toes with knees fully extended.
As mentioned, all study patients will complete Health Related Quality of Life Outcome (HRQOL) consisting Oswestry Disability Index (ODI), Visual Analog Scale, EQ-5D, Scoliosis Research Society-22 (SRS-22) and the Lumbar Stiffness Disability Index (LSDI) at 6 weeks, 3 months, 6 month, 12 and 24 months.
Data will be collected in a password-protected file and will be stored in an electronically secure environment, as specified in the research data security plan (RDSP).
Follow-up by the research coordinator as part of this study will not necessarily preclude or replace any follow-up by the treating physician or nursing staff as part of the routine standard of care.
- Keywords
- Activities of Daily Living (ADL), Complex Spinal Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Deformity Patients | For patients with disabling spinal deformities, long segment fusions have been shown to improve the health related quality of life (HRQOL). A consequence of spine fusion however is elimination of range of motion especially in the lumbar spine. Even in patients who report overall improvement in pain related domains, difficulty with some ADL's in this patient group has been well documented in previous studies. Complaints such as inability to dress independently, bathing of lower halves of their body, driving a motor vehicle, getting in and out of a chair/bed and performing perineal hygiene care following toileting have been reported. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life as measured by Oswestry Disability Index (ODI)
10 question survey that rates disability from low, moderate, to severe disability
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Change in Quality of Life as measured by Visual Analog Scale (VAS)
4 question survey that rates pain
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Change in Quality of Life as measured by EQ-5D
Survey that looks at 5 different components activities of daily living
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Change in Quality of Life as measured by Scoliosis Research Society (SRS) Form
22 or 30 question survey that rates scoliosis
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Change in Quality of Life as measured by Lumbar Stiffness Disability Index (LSDI) Form
Survey that rates lumbar stiffness
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start3 Sep 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Karikari, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037059
- Sponsor's protocol ID
- Pro00101177
- Acronym
- ADL
- Status last verified
- Oct 2021
- First submitted
- 25 Jul 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL) in Patients Undergoing Long Segment Deformity Surgery: A Prospective Study
- ClinicalTrials.gov ID
- NCT04037059
- Acronym / sponsor ID
- ADL / Pro00101177
- Keywords
- Activities of Daily Living (ADL), Complex Spinal Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 30 Jul 2019 (actual)
- 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.
This study is being done to assess the impact of arm length and abdominal (belly) width on patient performance of daily self-care activities following multiple level spinal fusions. The study will also assess if the number of levels operated on in the spinal fusion procedure affects your ability to perform Activities of Daily Living (ADL) and how long after surgery do the difficulties/limitations persist.
Detailed description
This is a prospective, single-center study of adult patients undergoing long segment spinal fusions to the pelvis (>5 levels).
Health Related Quality of Life Outcome (HRQOL) consisting of the Oswestry Disability Index (ODI), Visual Analog Scale, EQ-5D, Scoliosis Research Society-22 and 30 (SRS-22 and SRS-30) and the Lumbar Stiffness Disability Index (LSDI) will be collected preoperatively, 6 weeks, 3 months, 6 months, 12 and 24 months. All measures will be collected during clinic visits.
Primary and secondary objectives The primary objective is to determine the impact of body habitus on postoperative ADLs in patients undergoing long segment spinal fusions.
The secondary objective will be to determine if the number of levels of fusions impact the ability to perform ADLs and to study how long after surgery do the difficulties/limitations persist.
Study procedures Enrolled subjects meeting eligibility criteria and provide consent will be approached by the study coordinator and explained the purpose of the study, risks and benefits to participation, and queried about their interest in participation. Patients consenting to the study will have the following measurements performed by the clinician with an evaluation prior to surgery, during their 6 week, 3 month, 6 month, 12 and 24 month postoperative visits.
- Waist circumference using a measuring tape will be obtained from midway between the last ribs and the iliac crest as suggested by the World Health Organization and the International Diabetes Federation.
- The arm span (wingspan) or reach will be measured. To measure the arm span, the patient will be asked to stand against the wall with their arms extended sideways at a ninety-degree angle. Using a measuring tape, the distance from the tip of the middle finger of one hand to the tip of the middle finger in other arm will be measured and recorded.
- The distance from the ground to the tip of middle finger will be measured while the patient is asked to touch their toes with knees fully extended.
As mentioned, all study patients will complete Health Related Quality of Life Outcome (HRQOL) consisting Oswestry Disability Index (ODI), Visual Analog Scale, EQ-5D, Scoliosis Research Society-22 (SRS-22) and the Lumbar Stiffness Disability Index (LSDI) at 6 weeks, 3 months, 6 month, 12 and 24 months.
Data will be collected in a password-protected file and will be stored in an electronically secure environment, as specified in the research data security plan (RDSP).
Follow-up by the research coordinator as part of this study will not necessarily preclude or replace any follow-up by the treating physician or nursing staff as part of the routine standard of care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Deformity Patients | – | –For patients with disabling spinal deformities, long segment fusions have been shown to improve the health related quality of life (HRQOL). A consequence of spine fusion however is elimination of range of motion especially in the lumbar spine. Even in patients who report overall improvement in pain related domains, difficulty with some ADL's in this patient group has been well documented in previous studies. Complaints such as inability to dress independently, bathing of lower halves of their body, driving a motor vehicle, getting in and out of a chair/bed and performing perineal hygiene care following toileting have been reported. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are seeking evaluation and treatment at the Duke Spine Center and have been recommended to undergo spine surgery will be approached by the treating surgeon and/or the study coordinator about the study. The goal enrollment is 256 patients within 1 year.
Key inclusion criteria (3 listed)
- Adults18 to 80 years old
- Spinal fusion surgery involving thoracolumbar spine > 5 levels
- Ability to stand to obtain arm span, abdominal girth and ability to bend at the waist to obtain measurement
Key exclusion criteria (4 listed)
- Patients who are incarcerated, paraplegic or unable to return for follow-up visits
- Patients with prior lumbar fusions at the indicated levels for surgery
- Spinal fusion surgery involving thoracolumbar < 5 levels
- Patients who already have lumbopelvic fixation with iliac screws
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quality of Life as measured by Oswestry Disability Index (ODI)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
10 question survey that rates disability from low, moderate, to severe disability
Change in Quality of Life as measured by Visual Analog Scale (VAS)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
4 question survey that rates pain
Change in Quality of Life as measured by EQ-5D
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Survey that looks at 5 different components activities of daily living
Change in Quality of Life as measured by Scoliosis Research Society (SRS) Form
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
22 or 30 question survey that rates scoliosis
Change in Quality of Life as measured by Lumbar Stiffness Disability Index (LSDI) Form
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Survey that rates lumbar stiffness
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 17 May 2022.
- Individual participant dataSharing planned: No
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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.
Isaac Karikari, MD principal investigator
Duke University
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 Spinal Fusion and Activities of Daily Living Following Complex Spinal Fusions, run by Duke University 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 3 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 17 May 2022. 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?
Change in Quality of Life as measured by Oswestry Disability Index (ODI) (time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months). The study lists 5 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 17 May 2022.