Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT04037059
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Observational
Durham, North Carolina, 27710, United States
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
4 question survey that rates pain
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Survey that looks at 5 different components activities of daily living
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
22 or 30 question survey that rates scoliosis
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Survey that rates lumbar stiffness
Duke University
Other
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
Acronym: ADL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07596238
Back Pain, Low Back Pain
Vĩnh Long, Vinh Long, Vietnam
View Trial DetailsNCT06233617
Bone Diseases, Erector Spinae Plane Block
Poznan, Poznań, Poland
View Trial DetailsNCT05323448
Hemostasis, Hemostatics
Bordeaux, France
View Trial DetailsNCT07200557
Radiography, Spinal Fusion
Leuven, Belgium
View Trial Details