Ortho Research

Clinical Trials

STaR Trial

Study Contact:

Kaitlyn Shank 434-243-5653

IRB-HSR 20607

Clinic Visit Registration: 20607- Miller

Inclusion Criteria

  • Male and female military personnel & civilians with MLKI (grade III injury of 2 or more ligaments)
  • 16 to 55 years of age

Exclusion Criteria

  • Have a history of prior knee ligament surgery of the involved knee
  • Have a torn or avulsed patellar or quadriceps tendon
  • Have a periarticular or long bone fracture that is anticipated to preclude weight bearing after surgery
  • Require use of an external fixator to maintain reduction of the knee or soft tissue/open wound management for greater than 10 days
  • Planned staged surgical treatment for MLKI
  • Are unable to WB on the contralateral uninjured leg
  • Have a traumatic brain injury (TBI) that limits their ability to participate in their post-operative care or any condition that would preclude the ability to comply with post-operative guidelines
  • Skin or soft tissue injury that precludes early surgery and/or early rehabilitation
  • Surgical procedure that precludes early WB & ROM (i.e. surgery for extensor mechanism rupture or avulsion, vascular graft surgery)
  • Have multiple trauma that limits ability to participate in early rehabilitation
  • Have vascular surgery that precludes early rehabilitation
  • Have a skin or soft tissue injury that precludes early weightbearing or range of motion

Study Summary

  • Clinical Follow Ups (done in UVA clinic):
    • 1 week: knee exam, additional surgeries form?, concomitant meds, post-op home exercise log, AE reporting
    • 1 month: knee exam, AE reporting, PT case report, patient reported rehab, post-op home exercise log
    • 3 months: knee exam, concomitant medications, PT form, patient reported PT, complications
    • 6 months: knee exam, additional surgeries?, concomitant meds, PT case report, patient reported rehab, AE reporting
    • 9-12 months: Knee exam, additional surgeries?, concomitant meds, AE reporting
  • Research Visits (done remotely by Pitt):
    • Online questionnaires at: 6 months, 7-11 months, 12 months, 13-23 months, and 24 months

Payment

$400 total

  • Informed Consent & Screening – $50
  • Baseline Study Questionnaires – $55
  • Follow-up study Questionnaires
    • 6-months after surgery – $35
    • 12-months after surgery– $35
    • 24-months after surgery – $35
  • Survey of Rehabilitation Activities
    • 1-month after surgery – $10
    • 3-months after surgery – $10
    • 6-months after surgery – $10
  • Return to Activity Survey
    • 7-11 months after surgery & 13-23 months after surgery – $10 each time the survey is completed

Rehab Protocol Summary

  • Immediate post-op period, both groups are the same- no motion, NWB
  • After first post-op appointment:
    • Early Rehab: WBAT, unrestricted motion in ROM brace
    • Delayed Rehab: Brace locked in extension, no knee joint motion, NWB
  • After 4 weeks: no difference between groups

Covered Expenses

  • Procedures are standard of care. Patient will not be charged for the questionnaires (which is the only procedures being done strictly for research)
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