Clinical Trials

STABILITY II

Study Contact:

  • Kaitlyn Shank: 434-243-5653
  • Lizzie Leitch: 434-243-0256

HSR# 200234

Inclusion Criteria

  • The patient has an ACL- deficient knee
  • The patient is skeletally mature; i.e., epiphyseal growth plates are closed: if no, we need to upload the AP and Lateral View Radiographs
  • Two or more of the following criteria are true for the patient:
    • The patient competes in a competitive pivoting sport
    • The patient has generalized ligamentous laxity (i.e., Beighton score of 4 or greater)
    • The patient has a pivot shift of 2 or greater
    • The patient has a genu recruvatum of more than 10 degrees

Exclusion Criteria

  • The patient is younger than 14 or older than 25 years of age
  • The patient has undergone previous ACL reconstruction of either knee
  • The patient requires repair or reconstruction of the PCL, MCL, or LCL
  • The patient has a symptomatic articular cartilage defect that requires treatment other than debridement
  • The patient has a past/present history of inflammatory arthritis, metabolic bone, collagen, degenerative joint, or neoplastic disease
  • The patient has a femoral, tibial, or patellar fracture (other than Segond fractures)
  • The patient has an asymmetric varus or valgus greater than 3 degrees
  • The patient has a debilitating (per discretion of the treating surgeon) anterior knee pain that would preclude the use of QT or BPTB tissue as a graft
  • The patient has significant (per discretion of the treating surgeon) patellar or quad tendon tendonitis that would preclude the use of that tissue as a graft
  • The patient has a cognitive impairment or psychiatric illness that precludes informed consent OR renders the patient unable to complete questionnaires
  • The patient has no fixed address or means of contact
  • The patient has a major medical illness where life expectancy is less than 2 years
  • The patient is pregnant
  • The patient is not available for follow-up at specified time periods of before surgery, 3 months, 6 months, 12 months, 24 months post surgery
  • Other (per discretion of the surgeon)

Study Summary

  • Screening: Baseline questionnaires, clinical exam (pivot shift and ROM)
  • Surgery: Randomization will be done in the OR after completing inta-operative inclusion/exclusion review. Randomization groups:
    • ACLR with QT
    • ACLR with QT and LET
    • ACLR with BPTB
    • ACLR with BPTB and LET
  • Clinical Follow-Ups:
    • 6 weeks, 3months, 6 months, 12 months, 24 months
    • All visits will include ROM (by blinded assessor), pivot shift, PROs
    • Standing flexion x-ray at 24 month visit
  • STEP/LEAP Follow-Ups:
    • 6 month, 12 month and 24 months
    • Muscle strength by biodex or dynamometer- 6, 12, and 24mo
    • Functional Hop Series- 6, 12, and 24mo
    • Drop Vertical Jump- 6 and 12 month

Payment:

  • $290 total
  • Baseline: $50
  • 6-week PROs: $20
  • 12-week PROs: $20
  • 6-month: $50 ($25 for visit and PROs, $25 for LEAP test)
  • 12 month: $50 ($25 for visit and PROs, $25 for LEAP test)
  • 24 month: $50 ($25 for visit and PROs, $25 for LEAP test)
  • Incentive payment: if a subject completes all components of the 6, 12, and 24 month visits, they get an extra $50
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