This is a great day for the NITEP collaboration. Our proximal humerus fracture trial involving 3 and 4 part fractures is now finally published in the Plos Medicine. Our multicenter randomized trial revealed that surgical interventions, including locking plate fixation and hemiarthroplasty, offer no significant benefit over nonoperative treatment for displaced 3- and 4-part proximal humerus fractures in patients aged 60 and older. The study also highlighted a higher complication rate associated with surgical treatments.
The Nordic Innovative Trial to Evaluate Osteoporotic Fractures (NITEP) involved 160 patients from multiple centers between February 2011 and December 2019. Participants were randomly assigned to one of three groups: nonoperative treatment (54 patients), locking plate fixation (52 patients), or hemiarthroplasty (54 patients). The primary outcome measured was the Disabilities of the Arm, Shoulder, and Hand (DASH) score at a 2-year follow-up.
Key Findings
- Functional Outcomes: At the 2-year mark, the mean DASH scores were 30.4 for the nonoperative group, 31.4 for the locking plate group, and 26.6 for the hemiarthroplasty group. The differences between these groups were not statistically significant, indicating no clear advantage of surgical intervention over nonoperative treatment.
- Complication Rates: A total of 30 complications were recorded: 5.8% in the nonoperative group, 45% in the locking plate group, and 10% in the hemiarthroplasty group. The higher complication rate in the locking plate group is particularly noteworthy.
- Revisions: The revision surgery rate was 22% in the locking plate group, underscoring potential concerns regarding this surgical approach.
Clinical Implications
These findings suggest that for older adults with displaced 3- and 4-part proximal humerus fractures, nonoperative treatment may be as effective as surgical options, with a lower risk of complications. This challenges the prevailing preference for surgical intervention in such cases and highlights the need for individualized patient care strategies.
About the Study
The study, titled ”Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients (NITEP): An open-label randomized trial,” was published in PLOS Medicine on November 28, 2023. The research was a collaborative effort among institutions across Finland, Sweden, Estonia, and Denmark.