A bone stimulator is unlikely to help your 2-year-old nonunion and is not recommended based on the best available evidence.
The 2017 BMJ clinical practice guideline makes a strong recommendation AGAINST using low-intensity pulsed ultrasound (LIPUS) for bone healing, including nonunions, based on moderate to high-quality evidence showing no benefit for patient-important outcomes. 1
Why This Recommendation Matters
The guideline panel specifically addressed whether LIPUS would work for nonunions (like your 2-year-old fracture) versus fresh fractures. After extensive deliberation, they found no compelling anatomical or physiological reasons why LIPUS would be beneficial in nonunion cases. The trials examining nonunions were either at high risk of bias or didn't contribute sufficient outcome data. 1
What the Evidence Shows
The systematic review underlying this guideline found that LIPUS has:
- No impact on time to return to work or full weight bearing (the outcomes patients care most about)
- No effect on pain reduction
- No reduction in need for subsequent operations
- No improvement in radiographic healing time
The Burden vs. Benefit Calculation
Even if there were marginal benefits (which the evidence doesn't support), consider:
- Cost: $1,300-5,000 per device
- Time commitment: 20 minutes daily for 14-140 days
- Compliance issues: Many patients in trials had difficulty adhering to the regimen
- Travel burden: Device is cumbersome and may require special authorization for air travel
The Contradictory Evidence You May Encounter
Older Observational Studies
You'll find older studies claiming success with bone stimulators for nonunions:
- A 2015 registry study reported 86.2% healing in chronic nonunions treated with LIPUS 2
- Studies from the 1980s-2000s showed positive results with pulsed electromagnetic fields 3, 4, 5
- A 2022 UK study reported 84% success with combined magnetic field stimulators 6
Critical limitation: These are all observational studies without control groups. Nonunions can heal spontaneously or with other interventions, making it impossible to attribute healing to the stimulator. The BMJ guideline specifically notes that trials of nonunions were at high risk of bias. 1
FDA Approval Doesn't Equal Effectiveness
The FDA approved LIPUS for nonunions in 2000, and NICE initially supported its use in 2010. 1 However, regulatory approval preceded the high-quality randomized controlled trials that showed no benefit. The guideline panel explicitly recommends that healthcare organizations stop reimbursing LIPUS based on current evidence. 1
What You Should Do Instead
For a 2-year-old nonunion, the guideline suggests future research should focus on:
- Operative stabilization with or without autologous bone grafts (the current standard of care)
- Surgical application of adjuvant biomaterials
- Extracorporeal shock wave therapy (still investigational but more promising than LIPUS)
The Bottom Line Algorithm
For your established nonunion:
- Consult an orthopedic surgeon to evaluate mechanical stability and biological factors
- Address any underlying issues: infection, inadequate fixation, metabolic problems, vitamin D deficiency
- Consider revision surgery with bone grafting if indicated
- Do not waste time or money on bone stimulators - the evidence shows they won't help and may delay definitive treatment
The guideline panel, which included patients with lived experience of fractures, unanimously agreed that informed patients would choose not to use LIPUS. One patient panel member noted that discussing LIPUS "would unnecessarily take valuable time from the patient-clinician encounter." 1