Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

Status unconfirmed · Phase 3

Conditions studied: Ketorolac, Joint Fusion

In brief

In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct analgesic, but many orthopaedic surgeons have viewed NSAIDs with hesitancy because of evidence that they can lead to delayed bone healing. When evaluating bone healing across different NSAID formulas, ketorolac was found to cause no delay and lead to better union rates when compared to controls and other NSAIDs, respectively. Previous studies in the orthopaedic spine and trauma literature have suggested a detrimental effect of NSAIDs, specifically ketorolac, with regards to bone healing, while others have reported no delay in healing. A recent study from our institution found no detrimental effects on the healing of ankle fractures with the use of ketorolac in the immediate postoperative period. Additionally, the use of ketorolac was associated with less reliance on narcotic pain medications. The purpose of this prospective randomized study is to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis.

Key facts

Study ID

NCT04872283

Run by

Rothman Institute Orthopaedics

People needed

140

Starts

2019-05-23

Expected to finish

2021-12-31

Last updated by the study team

2021-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients over the age of 18 undergoing outpatient primary 1st MTPJ fusion by a fellowship-trained foot and ankle orthopaedic surgeon at the Rothman Orthopaedic Institute

You may not qualify if…

• Patients undergoing revision 1st MTPJ fusion;
• Patients with any allergies to any study medication;
• Patients with documented chronic narcotic use;
• Patients with renal insufficiency, as defined by history and preoperative creatinine level (Cr ≥ 2.1 mg/dl);
• Patients who are pregnant;
• Patients undergoing inpatient procedure.

Where it is running

• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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