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NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures

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ClinicalTrials.gov Identifier: NCT03880981
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Vanessa Franco, MD, PhD, University of California, Los Angeles

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Musculoskeletal Injury Drug: Ibuprofen 600 mg Drug: Acetaminophen Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Acetaminophen
Patients will receive 650mg PO Acetaminophen every 6 hours as needed for pain
Drug: Acetaminophen
acetaminophen 600mg po q6 hours prn pain

Active Comparator: Ibuprofen
Patients will receive 600mg PO Ibuprofen every 6 hours as needed for pain
Drug: Ibuprofen 600 mg
ibuprofen 600mg Po q 6 hours prn pain




Primary Outcome Measures :
  1. Incidence of non-union after tibia fracture [ Time Frame: 6 months ]
    Fractures

  2. Functional Recovery after Achilles Tendon Rupture [ Time Frame: 6 months ]
    Achilles Tendon Total Rupture Score measures functional recovery after Achilles tendon rupture on a scale of 0 (worse) to 100 (best).


Secondary Outcome Measures :
  1. Functional Impairment after Tibia Fracture on a scale of 1 to 3 (none to severe) [ Time Frame: 6 months ]
    The score quantifies functional impairment on a scale of 1 (none) to 3 (severe)

  2. Degree of pain after Tibia Fracture on a scale of 1-9 [ Time Frame: 6 months ]
    The score quantifies pain on a scale of 1 (none) to 9 (severe)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Adult patients (over 18) presenting within 24 hours of a tibia fracture
  • Adult patients (over 18) presenting within 24 hours of an Achilles tendon rupture

Exclusions:

Patients will be excluded if they:

  • have a contraindication to Ibuprofen or Acetaminophen use
  • don't have access to e-mail
  • require emergent surgery (such as an open fracture)
  • have a diagnosis of osteoporosis
  • have already taken one of the study drugs since their injury
  • are pregnant (due to their inability to take NSAIDs)
  • are < 18 years old (due to differences in bone and tendon healing).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880981


Contacts
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Contact: Vanessa Franco, MD PhD (310) 794-0585 vfranco@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Vanessa Franco, MD PhD Assistant Professor

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Responsible Party: Vanessa Franco, MD, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03880981     History of Changes
Other Study ID Numbers: VFranco
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Vanessa Franco, MD, PhD, University of California, Los Angeles:
fracture
tendon rupture
NSAID
healing

Additional relevant MeSH terms:
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Rupture
Tibial Fractures
Wounds and Injuries
Fractures, Bone
Leg Injuries
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action