Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures

NCT05000281 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: W81XWH2020063
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. 1,000 patients with tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management and no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).

Conditions

Tibia Fracture

Keywords

NSAID; Nonsteroidal Anti-Inflammatory Drug; Pain Interference; Persistent Pain; Pain Control; Opioid Utilization; Nonunion Surgery; Fracture Healing; Orthopaedic trauma

Outcome Measures

Primary Outcomes (1)

• Numbers of participants with nonunion (secondary surgery to promote union)

  Nonunion will be assessed by the presence of a secondary surgery to promote union after 3 months post definitive fixation surgery. Surgery operative notes and radiographs of each case will be independently reviewed by members of the METRC Central Adjudication Committee and if at least 2 members agree with the assessment of secondary surgery to promote union, no further review will be necessary. The METRC Central Adjudication Committee will convene to discuss the cases for which there is disagreement regarding nonunion assessment.

  Between 3 months and 12 months after definitive fixation surgery

Secondary Outcomes (4)

• Pain as assessed by the Brief Pain Inventory (BPI)

  Baseline, 3, 6, 12, months

• Pain interference as assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference

  Baseline, 3, 6, 12, months

• Physical and Psychosocial functioning as assessed by Patient Report Outcomes Measurement Information System (PROMIS)

  Baseline, 3, 6, 12, months

• Radiographic union as assessed by the modified Radiographic Union Scale in Tibial Fractures (mRUST)

  Between 3 months and 12 months after definitive fixation surgery

Study Arms (2)

NSAID

EXPERIMENTAL

Standard of care pain medication regimen with NSAIDs.

Drug: Ibuprofen

No NSAIDs

NO INTERVENTION

Standard of care pain medication regiment with no NSAIDs

Interventions

Ibuprofen DRUG

600 mg Ibuprofen 3 times a day for up to six weeks.

Also known as: Advil, Motrin

NSAID

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
• Patients 18-80 years old inclusive.
• Patients able to be followed at a Major Extremity Trauma \& Rehabilitation (METRC) facility for at least 12 months following injury

You may not qualify if:

• Patient unable to provide informed consent
• Patients who are current - intravenous drug user.
• Patients with a history of allergy to the study drugs.
• Patients unable to swallow oral medications or without functioning GI tract.
• Patients with a history of gastrointestinal bleeds or gastric perforation.
• Patients with a history of stroke or heart attack.
• Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
• Patients with any bleeding disorders.
• Patients with severe renal failure \[glomerular filtration rate (GFR):\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose.
• Patients undergoing daily treatment with systemic glucocorticoids before surgery.
• Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
• Patients with a Glasgow Coma Scale (GCS) \<15 at discharge.
• Patients with a closed head injury that precludes NSAIDS.
• Patients who are pregnant or lactating at time of screening
• Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 841112, United States

RECRUITING

MeSH Terms

Conditions

Tibial Fractures; Agnosia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Tara Taylor Joseph, MPH

CONTACT

410-614-6081; ttaylo56@jhu.edu

Trisha Chaffee

CONTACT

tchaffe2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: September 14, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

US (1)