What side effects are associated with this type of intervention?

Common treatments for tibia fractures, particularly NSAIDs, can lead to several side effects. These include gastrointestinal problems like ulcers and bleeding, increased cardiovascular risks, potential renal impairment, and possibly delayed bone healing. These side effects highlight the importance of carefully balancing pain relief with the potential for adverse outcomes.

What prior FDA approvals exist?

The FDA has approved various NSAIDs for the treatment of pain and inflammation associated with tibia fractures. These include drugs like ibuprofen, naproxen, and diclofenac, which inhibit the cyclooxygenase (COX) enzyme to reduce inflammation, pain, and fever. These medications are commonly used in clinical practice to manage pain and facilitate recovery in patients with tibia fractures.

What other types of research exist?

Promising novel alternatives to NSAIDs for tibia fracture patients include nerve growth factor inhibitors (e.g., tanezumab), dietary supplements like curcumin and Boswellia, and non-pharmacological interventions such as low-level laser irradiation and hyperbaric oxygen therapy. These options aim to manage pain and inflammation effectively while supporting bone healing.

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Ibuprofen for Tibia Fractures

Phase 3

Recruiting

Research Sponsored by Major Extremity Trauma Research Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 18-80 years inclusive

All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail

Must not have

Any bleeding disorders

Closed head injury that precludes NSAIDS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 12, months

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial will test if adding ibuprofen to usual care for a few weeks helps patients with tibia fractures feel better and use fewer opioids without increasing complications.

Who is the study for?

Adults aged 18-80 with tibia fractures treated with a nail, able to follow up at METRC for 12 months. Excluded are those allergic to NSAIDs, with severe renal failure or bleeding disorders, pregnant/lactating women, and others unable to consent or comply.

What is being tested?

The trial is testing if adding NSAIDs to standard pain management improves bone healing and reduces opioid use in patients with tibia fractures. It's a randomized study comparing two groups: one receiving NSAIDs for up to six weeks and the other not.

What are the potential side effects?

Possible side effects of taking NSAIDs may include stomach upset or bleeding, kidney problems in those already at risk, allergic reactions, and increased bruising or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have a tibia fracture treated with a nail.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder.

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I cannot take NSAIDs due to a head injury.

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I cannot swallow pills or have a non-functioning digestive system.

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I am allergic to the medication used in this study.

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I take aspirin or NSAIDs, but only low-dose aspirin (81mg).

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I am unable to understand and give consent for treatment.

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I am taking daily steroid medication before my surgery.

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I have had stomach bleeds or a hole in my stomach before.

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I have had a stroke or heart attack in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 12, months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 12, months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 12, months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Pain as assessed by the Brief Pain Inventory (BPI)

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

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

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NSAIDExperimental Treatment1 Intervention

Standard of care pain medication regimen with NSAIDs.

Group II: No NSAIDsActive Control1 Intervention

Standard of care pain medication regiment with no NSAIDs

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibuprofen

FDA approved

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

NSAIDs are commonly used in the treatment of tibia fractures due to their ability to inhibit cyclooxygenase (COX) enzymes, which are involved in the production of prostaglandins that cause inflammation, pain, and fever. By reducing prostaglandin levels, NSAIDs help manage pain and inflammation, which is crucial for improving patient comfort and mobility during recovery. This can also reduce the reliance on opioid analgesics, thereby minimizing the risk of dependency and other side effects associated with opioids.

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