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

The results of arthroscopic versus mini-open repair for rotator cuff tears at mid-term follow-up

<p>Abstract</p> <p>Background</p> <p>To prospectively evaluate patients who underwent a "mini-open" repair versus a completely arthroscopic technique for small to large size rotator cuff tears.</p> <p>Methods</p> <p>Fifty-two patients underwent "mini-open" or all arthroscopic repair of a full thickness tear of the rotator cuff. Patients who complained of shoulder pain and/or weakness and who had failed a minimum of 6 weeks of physical therapy and had at least one sub-acromial injection were surgical candidates. Pre and post-operative clinical evaluations included the following: 1) demographics; 2) Simple Shoulder Test (SST); 3) University of California, Los Angeles (UCLA) rating scale; 4) visual analog pain assessment (VAS); and 5) pre-op SF12 assessment. Descriptive analysis was performed for patient demographics and for all variables. Pre and post outcome scores, range of motion and pain scale were compared using paired t-tests. Analysis of variance (ANOVA) was used to evaluate any effect between dependent and independent variables. Significance was set at p is less than or equal to 0.05.</p> <p>Results</p> <p>There were 31 females and 21 males. The average follow-up was 50.6 months (27 – 84 months). The average age was similar between the two groups [arthroscopic x = 55 years/mini-open x = 58 years, p = 0.7]. Twenty-seven patients underwent arthroscopic repair and 25 underwent repair with a mini-open incision. The average rotator cuff tear size was 3.1 cm (range: 1–5 centimeters). There was no significant difference in tear size between the two groups (arthroscopic group = 2.9 cm/mini-open group = 3.2 cm, p = 0.3). Overall, there was a significant improvement from pre-operative status in shoulder pain, shoulder function as measured on the Simple Shoulder test and UCLA Shoulder Form. Visual analog pain improved, on average, 4.4 points and the most recent Short Shoulder Form and UCLA scores were 8 and 26 respectively. Both active and passive glenohumeral joint range of motion improved significantly from pre-operatively.</p> <p>Conclusion</p> <p>Based upon the number available, we found no statistical difference in outcome between the two groups, indicating that either procedure is efficacious in the treatment of small and medium size rotator cuff tears.</p> <p>Level of Evidence</p> <p>Type III</p