Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Isaac Karikari, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided