Last reviewed · How we verify

NCT03880981

NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures

Status unknown NA Last updated 19 March 2019
What this trial tests

NA trial testing Ibuprofen 600 mg in Musculoskeletal Injury in 456 participants. Status unknown.

Timeline
1 August 2019
Primary endpoint
31 July 2020
31 July 2020

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingquadruple
Primary purposetreatment
Enrollment456
Start date1 August 2019
Primary completion31 July 2020
Estimated completion31 July 2020

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Musculoskeletal Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: The Emergency Department (ED) typically serves as the front line for patients with acute fractures and tendon ruptures. Pain control for these patients is an essential task of the ED physician. With the advent of the opioid epidemic, ED physicians are becoming more inclined to prescribe non-narcotic pain medications such as non-steroidal anti-inflammatory drugs (NSAIDs). Yet, the effects of NSAIDs on musculoskeletal healing are controversial. The few human studies examining the effects of NSAID use on fracture healing have provided conflicting results. Even less is known about the effects of NSAIDs on tendon healing as this information has largely been gleaned from rodent studies with contradictory findings. There has never been a large, prospective, randomized, double-blinded study to determine the effects of NSAIDs on healing after fractures or tendon ruptures. Here, I propose to pilot the first prospective, randomized, double-blinded study examining the effects of NSAID use on healing after tibia fractures and Achilles tendon ruptures. Aim 1 seeks to determine whether NSAID use is associated with an increased incidence of fracture nonunion and worse functional recovery six months following tibia fractures. I hypothesize that NSAID use after tibia fractures will be associated with an increased incidence of fracture nonunion and worse functional recovery. Aim 2 seeks to determine whether NSAID use is associated with worse functional recovery six months after Achilles tendon ruptures. I hypothesize that NSAID use after Achilles tendon ruptures will be associated with worse functional recovery. Significance: Emergency Department providers commonly prescribe NSAIDs for pain control following fractures and tendon injuries. However, the implications of this practice on bone and tendon healing are unknown. This proposal will pilot the first prospective, randomized, double-blinded study to determine whether NSAID use affects healing after tibia fractures and Achilles tendon ruptures. Results from this study will impact NSAID prescribing patterns for tibia fractures and Achilles tendon ruptures in the ED, either by demonstrating that they impair recovery and should be avoided, or that they need not be withheld as an effective non-narcotic form of pain control.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Ibuprofen 600 mg

Trials testing the same drug.

Other recruiting trials for Musculoskeletal Injury

Currently open trials in the same condition.

Other University of California, Los Angeles trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03880981.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing