Ortho Research

Clinical Trials

HARMS-CP

Contact

Ashley Byrne

434-243-0289

AEB6Q@hscmail.mcc.virginia.edu

Inclusion Criteria

  • Male or Female
  • Ages: 8-21
  • Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level
  • Coronal curve >50 degrees on sitting film (as measured by ‘greatest Cobb’)

OR

  • Kyphotic curve >70 degrees on sitting film (as measured by T5-T12)

AND

  • A spinal fusion is being undertaken and the patient/family is proceeding with the spinal fusion (with any level of distal fusion).
  • Growing Rod treatment will not be included

OR

  • A spinal fusion is not being undertaken (Non-operative cohort) either because
  • The family has refused surgery

OR

  • The surgery is not recommended at this point

OR

  • Surgery is recommended but is not being undertaken because they are on a waiting list, and are being enrolled as a non-op patient because they will be on the waiting list for >18 months.

Exclusion Criteria

  • Previous operated scoliotic spine deformity
  • Diagnosis of Rett’s Syndrome
  • Concomitant lower extremity surgery (within 3 months of spinal fusion)
  • Cornelia de Lange Syndrome or any pervasive genetic disorder whose effects are due to much more than the static cortical injury.
  • Ambulatory spastic diplegic without upper extremity impairment or speech, swallowing or other involvement.

Study Summary

  • First Erect – 4-6 weeks post-surgery
  • 6 months post-surgery
  • 12 months post-surgery
  • 24 months post-surgery
  • 5, 10, 15, 20, 25 years post-surgery

Pre-operative

  • Enrollment Information, General Patient Data, Physical Demographics, Physical Status, Gross Motor Function Classification System (GMFCS), Pre-Blood Work (Surgical Patients only), Pain & Medications, Radiographs, Sitting Ability, Frequency of Non-elective Hospitalizations, Surgeon indications for surgery, Caregiver-Patient indications for surgery, Non-op patients – Caregiver-Patient reasons for no spinal fusion, HRQOL tools: CPCHILD, HUI, Questions regarding Health and Participation, Clinical Photographs – (if collected as a part of the patients routine care)

First Erect

  • Radiographs, Physical Demographics, Pain & Medications, Sitting Ability, Activity Level, Clinical Implant Prominence, Complications Data

6 month, 1, 2, 5, 10, 20, 25 year

  • Radiographs, Physical Demographics, Pain & Medications, Sitting Ability, Activity Level, Clinical Implant Prominence, Complications Data, HRQOL tools: CPCHILD, HRQOL tools: HUI, HRQOL tools: External Verification, Questions regarding Health and participation

Payment

  • $50 check for pre-op, 6 months, 1 year, 2 year follow-up appointments
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