Surgical and nonsurgical treatments offer similar functional outcomes for elderly patients with two-part proximal humerus fractures, according to a multinational research group.
Surgical procedures to implant locking plates for the treatment of those fractures produce no clinically significant benefit over nonoperative treatment among patients ages 60 or older at two-year follow-up, according to findings from the Nordic Innovative Trial to Evaluate osteoPorotic Fractures (NITEP) group. The group’s study, the first randomized controlled trial to examine surgical and nonsurgical treatment methods for two-part proximal humerus fractures, was published in PLOS Medicine.
“Randomized controlled studies comparing [locking plate procedures] and nonoperative treatments have been published only recently,” says Aleksi Reito, MD, PhD, NITEP researcher at the Central Finland Central Hospital. “There is no prior randomized controlled trial comparing nonoperative treatment and locking plate procedures for two-part fractures in this age group. However, our results are in line with previous studies investigating three- or four-part fractures.”
Indeed, a prior study in the Journal of Orthopaedic Trauma found that patients ages 60 or older with three- or four-part humerus fractures exhibited no functional outcome differences a year after their treatment was completed. Studies like these may help physicians better determine when surgery is indicated for addressing such fractures.
“[The NITEP] study certainly builds upon research that I’ve done previously,” says Addie Majed, BSc, FRCS (T&O), Dip Bio MD, Consultant Trauma & Orthopedic Surgeon at the Royal National Orthopaedic Hospital in the United Kingdom, whose research on treatment decision-making for proximal humerus fractures has appeared in Shoulder & Elbow. “It does parallel some other studies and reviews, but it helps add information to the overall picture as to whether medical evidence exists in favor of surgical intervention as opposed to conservative treatment.”
To assess whether locking plate surgery offered benefits compared to nonsurgical treatment, the NITEP study randomly divided 88 patients into two groups: one that underwent surgery with locking plates and another that utilized only conservative treatment.
Both groups wore a collar-cuff or sling for three weeks after hospitalization to reduce pain, and both received physiotherapy. This therapy included pendulum exercises and other range-of-motion activities as permitted by patients’ pain. Both groups also had access to supervised physiotherapy rehabilitation sessions. Four was the median number of supervised sessions for both groups.
Outcomes were primarily measured using the Disabilities of the Arm, Shoulder, and Hand (DASH) score. This score uses a 100-point scale, with a lower score indicating a better outcome. This patient-reported outcome measure was acquired two years after treatment.
“DASH has been the most widely used score for proximal humerus fracture studies,” Dr. Reito says. “A 10-point difference [in DASH scores] is considered as a clinically meaningful difference since the patient can observe it.”
At two-year follow-up, the operative group’s mean DASH score was 18.5, while the nonoperative group’s score was 17.4 — a statistically insignificant difference.
Secondary measures, including Constant-Murley score, the visual analogue scale for pain, the quality-of-life questionnaire, the EuroQol Group’s 5-dimension self-reported questionnaire and the Oxford Shoulder Score, also did not see clinically significant differences between groups.
“The study’s outcome measures ... looked at the most common measures for function,” Dr. Majed says. “The results echo what’s been published in the past. There is no clear evidence that surgical intervention provides any significant statistical improvement in outcomes compared with conservative management.”
In addition, the three instances of complications in the study all occurred in the surgical group. Though not statistically significant, that is still worth noting, according to Dr. Reito.
“These were all surgery-related complications, which highlight the risk-benefit ratio,” he explains.
Dr. Reito and his colleagues are currently studying three- and four-part proximal humerus fractures utilizing similar methods as they did to examine two-part fractures. They also plan on examining different forms of physiotherapy in nonoperative treatment for proximal humerus fractures.
Though the increased use of locking plates in the treatment of two-part proximal humerus fractures is not an evidence-based practice according to the NITEP and other studies, more research needs to be performed to reach a definitive conclusion about best practices regarding those fractures.
“All surgical interventions should be decided on a case-by-case basis,” Dr. Majed says. “Personally, I am looking at the process of how surgeons decide whether to operate or not, and hopefully, that will help us with the body of knowledge around these injuries.”