Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL)

Spinal Fusion Clinical Trial

— ADL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037059
• Other study ID #: Pro00101177
• Status: Completed
• Start date: September 3, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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. 1. 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. 2. 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. 3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adults18 to 80 years old

2. Spinal fusion surgery involving thoracolumbar spine > 5 levels

3. Ability to stand to obtain arm span, abdominal girth and ability to bend at the waist to obtain measurement

Exclusion Criteria:

1. Patients who are incarcerated, paraplegic or unable to return for follow-up visits

2. Patients with prior lumbar fusions at the indicated levels for surgery

3. Spinal fusion surgery involving thoracolumbar < 5 levels

4. Patients who already have lumbopelvic fixation with iliac screws

Related Conditions & MeSH terms

• Activities of Daily Living Following Complex Spinal Fusions
• Spinal Fusion

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life as measured by Oswestry Disability Index (ODI)	10 question survey that rates disability from low, moderate, to severe disability	Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Primary	Change in Quality of Life as measured by Visual Analog Scale (VAS)	4 question survey that rates pain	Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Primary	Change in Quality of Life as measured by EQ-5D	Survey that looks at 5 different components activities of daily living	Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Primary	Change in Quality of Life as measured by Scoliosis Research Society (SRS) Form	22 or 30 question survey that rates scoliosis	Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Primary	Change in Quality of Life as measured by Lumbar Stiffness Disability Index (LSDI) Form	Survey that rates lumbar stiffness	Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months