Hip Osteoarthritis
Conditions
Brief summary
The primary objective of investigators' proposed study is to demonstrate that the following two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS) scores up to 3 months post-operatively: one that is administered a modified multimodal analgesic pathway without opioids and the other administered the current standard multimodal analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The secondary objective is to demonstrate that these cohorts will also have equivalent functional outcomes as determined by both objective measures (such as hip range of motion) and patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.
Interventions
OTHERExclusion of opioid analgesics
The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients of all ages with end-stage primary hip osteoarthritis.
Exclusion criteria
* Patients with creatinine clearance between 30 and 60 mL/min * Use of any opioid analgesics in the 6 months preceding surgery * Revision total hip arthroplasty * Patients with liver insufficiency * Patients on chronic anticoagulation * Workers compensation patients * Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any reason (e.g. allergies)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores | From immediate post-operative period to 3 months post-operatively | Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS) | From pre-operative clinic visit to immediate post-operative period, then to 3 months post-operatively | A patient-reported measure that assesses components such as assesses patient pain, satisfaction including stiffness and range of motion, activity limitations-daily living, sports and recreation function, and quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. |
| Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale | From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively | The UCLA scale is a patient-reported measure ranging from 1 to 10. Patients indicate their most appropriate activity level, with 1 defined as no physical activity, dependent on others and 10 defined as regular participation in impact sports. |
Outcome results
None listed