A new study published in Journal of the American Medical Association (JAMA) explores the treatment of displaced fractures of the proximal humerus. Patients included in the study had unclear indications for surgery where a surgeon considered surgery, but the fracture did not have to meet surgical criteria by Neer (1 cm or 45° angulation of displacement). For study participants, surgical and non-surgical treatment with a sling did not show a clinically significant difference in treatment outcome.
33 UK hospitals participated in recruitment for this multi-center study. Patients did not qualify for the study if they had an injured shoulder joint, open fracture(s), inability to understand trial consent or rehabilitation procedures, contraindication for surgery, pathologic fracture not due to osteoporosis, terminal illness or were not a current resident of the hospital treatment area. The primary treatment measure was the Oxford Shoulder Score (OSS), a self-reported outcome measure found to correlate well with physical outcome measures such as strength, passive and active range of motion. Secondary measures consisted of the Short-Form 12 health survey, which measures both physical and mental health components and the 3-level EuroQol health status measure (EuroQol 5D/EuroQol 5D-3L), which rates health as a number with a 1 for perfect health, 0 for death and negative values for “states worse than death.” All measures were collected at 3, 6, 12 and 24-month intervals. Information about complications related to surgery and fracture, complications needing further treatment, medical complications from their hospital stay and mortality were also collected.
In an unpublished pilot study by one of the authors, a 5-point difference in OSS score was found between surgical and non-surgical groups. According to OSS developers, a 5-point difference was the threshold of a clinically important difference between groups. Based on the pilot study information, it was found 100 patients were needed per group to have a SD of 12, an effect size of 0.40, a power of 80% and 5% significance. With an estimated 20% loss to follow-up, the authors recruited 250 patients. The 250 patients in the study were either randomized to a surgical or non-surgical (sling) treatment group, with 125 patients per group. Among the surgical group, locking plates were the type of hardware most commonly used, but hemiarthroplasty, intramedullary nails, and other methods were also used. In the non-surgical group, slings were recommended for as long as needed (usually 3 weeks or more). Both groups were also referred to physiotherapy and other rehabilitation services as needed for treatment.
At the start of the study, there were no statistically significant differences between the surgical and non-surgical groups, except the non-surgical group had more smokers. Both treatment groups had cross-overs. In the surgical group, 16 participants did not have surgery as randomized, including 6 patients found unfit for surgery, and a further 8 patients who changed their mind. In the non-surgical group, 2 patients received surgery, 1 due to a patient changing their mind, and 1 due to a surgeon changing their mind.
During the treatment and the follow-up period, there were no statistically significant differences between treatment groups in OSS or other outcome measures. For patients in the study, non-surgical treatment with a sling appeared to be as effective as surgical treatment. It is important to note that patients in the study were not all of the displaced proximal humerus fractures which presented at participating clinics, but only those patients with unclear indications for surgery. Patients with clear indications for surgery still received surgical intervention. For example, in this study, only 45% of screened patients were found to be eligible. While this study presents evidence contrary to the trend of increased surgical treatment for most displaced proximal humerus fractures, this study should not be misinterpreted as meaning surgery should not be performed when clear surgical indications are present such as multiple upper limb fractures, open fractures, pathologic fractures or severe soft tissue compromise (Theivendran et al.)
Rangan A, Handoll H, Brealey S, Jefferson L, Keding A, Martin BC, Goodchild L, Chuang LH, Hewitt C, Torgerson D; PROFHER Trial Collaborators. Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial. JAMA. 2015 Mar 10;313(10):1037-47. doi: 10.1001/jama.2015.1629. PubMed PMID: 25756440.
Wise J. Surgery is no better than a simple sling for displaced fracture of upper arm, study finds. BMJ. 2015 Mar 10;350:h1304. doi: 10.1136/bmj.h1304. PubMed PMID: 25762346.
Theivendran K, Hassan S, Tambe A, Cresswell T, Clark D.I. Response to Wise J. Surgery is no better than a simple sling for displaced fracture of upper arm, study finds. BMJ 2015;350:h1304. doi: 10.1136/bmj.h1304.
Neer CS 2nd. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970 Sep;52(6):1077-89. PubMed PMID: 5455339. Abstract