标题：Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus the PROFHER randomized clinical trial

作者：Rangan A1, Handoll H2, Brealey S3, Jefferson L3, Keding A3, Martin BC3, Goodchild L1, Chuang LH4, Hewitt C3, Torgerson D3; PROFHER Trial Collaborators.

网址:

求助者：jkbb

• 求助时间：2015/6/24 9:32:27
• 求助状态：AB图书馆客服已找到全文，详情咨询在线客服qq 1257749646
• 文献摘要：

IMPORTANCE:

The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing.

OBJECTIVE:

To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck.

DESIGN, SETTING, AND PARTICIPANTS:

A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis.

INTERVENTIONS:

Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups.

MAIN OUTCOMES AND MEASURES:

Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality.

RESULTS:

There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; P = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; P = .58); and mortality (9 patients vs 5 patients; P = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay.

CONCLUSIONS AND RELEVANCE:

Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus.

TRIAL REGISTRATION:

isrctn.com Identifier: ISRCTN50850043.

文献《Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus the PROFHER randomized clinical trial》已经找到全文，详情请咨询在线客服 qq 1257749646。
如果您还有其他需要寻找全文的文献，请点击文献求助提交

说明：文献求助是指AB图书馆根据读者的需求，为读者查找论文资料的服务。如果您搜索到相关资料，但不能获取全文，此时便可将有关信息提交求助，由值班客服为您寻找所需文献的全文。提供的文献均来自网络共享资源，不涉及版权交易；如侵犯了您的权利，请告知在线客服，立马删除。文件格式以PDF格式为主。