Clinical Trials

PEPPER

Contact

Eric McVey

434-243-5382

edm9u@virginia.edu

Inclusion Criteria

  • Males and females 21 years of age or older
  • Undergoing elective primary or revision hip or knee replacement
  • Patient has necessary mental capacity to participate and is able to comply with study protocol requirements
  • Patient is willing and able to give consent and participate
  • Patient is willing and able to be randomized

Exclusion Criteria

  • No patient undergoing total hip or knee replacement who has been enrolled in this study for a prior hip or knee replacement can be enrolled for a second hip or knee replacement in this study.
  • No patient that is currently actively enrolled in another clinical trial may be enrolled in this study.
  • Women who are pregnant or breastfeeding, as well as those of reproductive potential unless there is a negative urine pregnancy test.
  • Patients on chronic (longer than the prior 6 months) anticoagulation other than with antiplatelet medications
  • Documented gastrointestinal, cerebral, or other hemorrhage within 3 months of the operation
  • A prior episode of hypersensitivity or adverse reaction to heparin
  • A known diagnosis of defective hemostasis
  • Within one month of an operative procedure involving the eye, ear, or central nervous system
  • Severe uncontrolled hypertension with systolic BP > 220mmHg and diastolic BP > 120mmHg
  • An absolute body weight of less than 41 kilograms (90.4 lbs) on day of enrollment
  • Vulnerable patient populations including prisoners and institutionalized individuals

Study Summary

  • Baseline / pre-op. HOOS or KOOS, PROMIS-10, OSWESTRY, Charlson Comorbidity
  • Randomized. Maximum 1 week before surgery and Minimum 1 day before surgery.
  • Surgery. Begin DVT prophylaxis before surgery for Aspirin or Warfarin or 24 hours after surgery for Rivaroxaban
  • 3 weeks post op – phone call from GSR, LLC
  • 3 months post op- phone call from GSR, LLC
  • 6 months post op – phone call from GSR, LLC

Payment

There is no payment for participation

Contact Sarah Spangler (cc Eric McVey) with patient name, MRN, DOS, study visit

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