Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial

BACKGROUND: Fractures of the proximal humerus are common injuries and account for 4-5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2-10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions. We aim to compare the effect of osteosynthesis with angle-stable plate with non-surgical management, and the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management. METHODS/DESIGN: We will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two-year period. We plan to include 162 patients. A central randomisation unit will allocate patients. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy regardless of treatment allocation. Patients will be followed at least one year. The primary outcomes will be the overall score on the Constant Disability Scale, and its pain subscale, measured at 12 months. A blinded physiotherapist will carry out the assessments. Other secondary outcomes are Oxford Shoulder Score, and general health status (Short Form-36)

Patients with shoulder impingement remain satisfied 6 years after arthroscopic subacromial decompression: A prospective study of 46 patients

Background Although arthroscopic subacromial decompression (ASD) is a common procedure for treatment of shoulder impingement, few long term results have been published. In this prospective study, we determined whether the high degree of patient satisfaction at 6 months postoperatively reported by us earlier remained at the 6-year follow-up. Patients and methods We originally reported high patient satisfaction 6 months after ASD for shoulder impingement in 50 prospectively studied patients using the Disability of the Arm Shoulder and Hand questionnaire (DASH) and the Visual Analog Scale (VAS). Patients with associated shoulder disorders were excluded. The surgeons were experienced shoulder arthroscopists. 6 years after surgery, the DASH questionnaire and the VAS were sent to these 50 patients. 2 patients had other medical problems of the upper extremity that affected the DASH and VAS scores, 1 patient was lost to follow-up, and another refused to participate. Thus, 46 patients with a mean age of 55 (33-78) years were included in this 6-year evaluation. Results The considerable improvement in both the DASH score and the VAS that was observed 6 months after surgery persisted or had even improved 6 years after surgery. Interpretation Properly selected patients with shoulder impingement treated with ASD remain satisfied 6 years after surgery

The Bankart repair versus the Putti-Platt procedure: A randomized study with WOSI score at 10-year follow-up in 62 patients

Background and purpose This randomized study compared clinical results after surgery for posttraumatic shoulder instability with either an anatomical repair or an older, less anatomical but commonly used method. The less anatomical procedure has been considered quicker and less demanding, but it has been questioned regarding the clinical result. We therefore wanted to compare the clinical outcome of the two different procedures. Our hypothesis was that the anatomical repair would give less residual impairment postoperatively

Rationale and design of the plate or pin (pop) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial

To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN) with a Titanium Elastic Nail (TEN) for adults with a dislocated midshaft clavicular fracture. Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures. Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed. The POP study is registered in the Dutch Trial Register (NTR NTR2438