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Completed

NCT Number: NCT04441112

Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial

Clinicians commonly utilize intraarticular injections to treat symptomatic primary arthritis. Steroid injections are common yet have immune-modulating effects and can alter gene expression which may delay definitive arthroplasty and further damage cartilage. Non-steroidal anti-inflammatory (NSAID) injections may offer a safer profile due to their differing mechanism of action; however, there is a relative dearth of information regarding their efficacy. This non-inferiority study compares the effectiveness of triamcinolone versus ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and knee.

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Key information

Conditions

Arthritis Knee Arthritis of Hip

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic, radiographically proven degenerative joint disease in the hip or knee

Exclusion criteria

  • recent injection in the hip or knee within the previous 3 months
  • history of traumatic osteoarthritis or ligamentous reconstruction
  • chronic narcotic use
  • history of inflammatory or neuropathic arthropathy
  • pregnant and/or nursing women
  • allergy or strong reaction to study medications

Treatment and study plan

Ketorolac Intraarticular Injection

Drug

Injections will be given under ultrasound guidance with one of two possible medications.

Triamcinolone Intraarticular Injection

Drug

Injections will be given under ultrasound guidance with one of two possible medications.

Primary outcomes

  1. Change in Visual Analogue Scale (Baseline to One Week Post-injection)

    Time frame: Comparing baseline to one week post-injection

    Pain Score

  2. Change in Visual Analogue Scale (Baseline to One Month Post-injection)

    Time frame: Comparing baseline to one month post-injection

    Pain Score

  3. Change in Visual Analogue Scale (Baseline to Three Months Post-injection)

    Time frame: Comparing baseline to three months post-injection

    Pain Score

  4. Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)

    Time frame: Comparing baseline to one week post-injection

    Overall patient wellbeing

  5. Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)

    Time frame: Comparing baseline to one month post-injection

    Overall patient wellbeing

  6. Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)

    Time frame: Comparing baseline to three months post-injection

    Overall patient wellbeing

  7. Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)

    Time frame: Comparing baseline to one week post-injection

    Functionality and pain of affected knee

  8. Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)

    Time frame: Comparing baseline to one month post-injection

    Functionality and pain of affected knee

  9. Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)

    Time frame: Comparing baseline to three months post-injection

    Functionality and pain of affected knee

  10. Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)

    Time frame: Comparing baseline to one week post-injection

    Functionality and pain of affected hip

  11. Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)

    Time frame: Comparing baseline to one month post-injection

    Functionality and pain of affected hip

  12. Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)

    Time frame: Comparing baseline to three months post-injection

    Functionality and pain of affected hip

Sponsors and collaborators

Lead sponsor

Saint Alphonsus Regional Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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