NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures

NCT03880981 | Unknown DMC

• 1 other identifier: VFranco
• Study Type: interventional
• Target: 456
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Musculoskeletal Injury

Keywords

fracture; tendon rupture; NSAID; healing

Outcome Measures

Primary Outcomes (2)

• Incidence of non-union after tibia fracture

  Fractures

  6 months

• Functional Recovery after Achilles Tendon Rupture

  Achilles Tendon Total Rupture Score measures functional recovery after Achilles tendon rupture on a scale of 0 (worse) to 100 (best).

  6 months

Secondary Outcomes (2)

• Functional Impairment after Tibia Fracture on a scale of 1 to 3 (none to severe)

  6 months

• Degree of pain after Tibia Fracture on a scale of 1-9

  6 months

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

Patients will receive 650mg PO Acetaminophen every 6 hours as needed for pain

Drug: Acetaminophen

Ibuprofen

ACTIVE COMPARATOR

Patients will receive 600mg PO Ibuprofen every 6 hours as needed for pain

Drug: Ibuprofen 600 mg

Interventions

Ibuprofen 600 mg DRUG

ibuprofen 600mg Po q 6 hours prn pain

Ibuprofen

Acetaminophen DRUG

acetaminophen 600mg po q6 hours prn pain

Acetaminophen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Fractures, Bone

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Vanessa Franco, MD PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Franco, MD PhD

CONTACT

(310) 794-0585; vfranco@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 19, 2019
• Study Start: August 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share