Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL)
Condition: Spinal Fusion; Activities of Daily Living Following Complex Spinal Fusions
Study type: Observational

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.
    

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.

        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.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.
      
Keywords: Activities of Daily Living (ADL); Complex Spinal Fusion