Robert Zura1, Gregory J Della Rocca2, Samir Mehta3, Andrew Harrison4, Chris Brodie5, John Jones6, R Grant Steen7. 1. Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA. Electronic address: Robert.Zura@duke.edu. 2. Department of Orthopaedic Surgery, University of Missouri, Columbia, MO, USA. Electronic address: dellaroccag@health.missouri.edu. 3. Department of Orthopaedic Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. Electronic address: Samir.Mehta@uphs.upenn.edu. 4. Bioventus LLC, Amsterdam, Netherlands. Electronic address: Andrew.Harrison@bioventusglobal.com. 5. Bioventus LLC, Durham, NC 27703, USA. Electronic address: Chris.Brodie@bioventusglobal.com. 6. Bioventus LLC, Durham, NC 27703, USA. Electronic address: John.Jones@bioventusglobal.com. 7. Bioventus LLC, Durham, NC 27703, USA. Electronic address: Grant.Steen@bioventusglobal.com.
Abstract
BACKGROUND: Established fracture nonunions rarely heal without secondary intervention. Revision surgery is the most common intervention, though non-surgical options for nonunion would be useful if they could overcome nonunion risk factors. Our hypothesis is that low-intensity pulsed ultrasound (LIPUS) can enhance heal rate (HR) in fractures that remain nonunion after one year, relative to the expected HR in the absence of treatment, which is expected to be negligible. METHODS: We collated outcomes from a prospective patient registry required by the U.S. Food & Drug Administration. Patient data were collected over a 4-year period beginning in 1994 and were individually reviewed and validated by a registered nurse. Patients were only included if they had four data points available: date when fracture occurred; date when LIPUS treatment began; date when LIPUS treatment ended; and a dichotomous outcome of healed vs. failed, assessed by clinical and radiological criteria. Data were used to calculate two derived variables: days to treatment (DTT) with LIPUS, and days on treatment (DOT) with LIPUS. Every validated chronic nonunion patient (DTT>365 days) with complete data is reported. RESULTS: Heal rate for chronic nonunion patients (N=767) treated with LIPUS was 86.2%. Heal rate was 82.7% among 98 patients with chronic nonunion ≥5 years duration, and 12 patients healed after chronic nonunion >10 years (HR=63.2%). There was more patient loss to follow-up, non-compliance, and withdrawal, comparing chronic nonunion patients to all other patients (p<0.0001). Patient age was the only factor associated with failure to heal among chronic nonunions (p<0.004). Chronic nonunion patients averaged 3.1 surgical procedures prior to LIPUS, but some LIPUS-treated patients were able to heal without revision surgery. Among 91 patients who received LIPUS ≥90 days after their last surgery, HR averaged 85.7%, and the time from last surgery to index use of LIPUS averaged 449.6 days. CONCLUSIONS: Low-intensity pulsed ultrasound enhanced HR among fractures that had been nonunion for at least 1 year, and even healed fractures that had been nonunion >10 years. LIPUS resulted in successful healing in the majority of nonunions without further surgical intervention.
BACKGROUND: Established fracture nonunions rarely heal without secondary intervention. Revision surgery is the most common intervention, though non-surgical options for nonunion would be useful if they could overcome nonunion risk factors. Our hypothesis is that low-intensity pulsed ultrasound (LIPUS) can enhance heal rate (HR) in fractures that remain nonunion after one year, relative to the expected HR in the absence of treatment, which is expected to be negligible. METHODS: We collated outcomes from a prospective patient registry required by the U.S. Food & Drug Administration. Patient data were collected over a 4-year period beginning in 1994 and were individually reviewed and validated by a registered nurse. Patients were only included if they had four data points available: date when fracture occurred; date when LIPUS treatment began; date when LIPUS treatment ended; and a dichotomous outcome of healed vs. failed, assessed by clinical and radiological criteria. Data were used to calculate two derived variables: days to treatment (DTT) with LIPUS, and days on treatment (DOT) with LIPUS. Every validated chronic nonunion patient (DTT>365 days) with complete data is reported. RESULTS: Heal rate for chronic nonunion patients (N=767) treated with LIPUS was 86.2%. Heal rate was 82.7% among 98 patients with chronic nonunion ≥5 years duration, and 12 patients healed after chronic nonunion >10 years (HR=63.2%). There was more patient loss to follow-up, non-compliance, and withdrawal, comparing chronic nonunion patients to all other patients (p<0.0001). Patient age was the only factor associated with failure to heal among chronic nonunions (p<0.004). Chronic nonunion patients averaged 3.1 surgical procedures prior to LIPUS, but some LIPUS-treated patients were able to heal without revision surgery. Among 91 patients who received LIPUS ≥90 days after their last surgery, HR averaged 85.7%, and the time from last surgery to index use of LIPUS averaged 449.6 days. CONCLUSIONS: Low-intensity pulsed ultrasound enhanced HR among fractures that had been nonunion for at least 1 year, and even healed fractures that had been nonunion >10 years. LIPUS resulted in successful healing in the majority of nonunions without further surgical intervention.