A Double-Blinded Placebo Randomized Controlled Trial Evaluating Short-term Efficacy of Platelet-Rich Plasma in Reducing Postoperative Pain After Arthroscopic Rotator Cuff Repair: A Pilot Study.

BACKGROUND: We aimed to determine whether patients with arthroscopically repaired rotator cuff (RC) tears would have reduced pain and improved function after ultrasound-guided platelet-rich plasma (PRP) injections compared with placebo injection. HYPOTHESIS: PRP compared with placebo (saline) was more effective in reducing pain at the site of an RC injury that has undergone arthroscopic repair. STUDY DESIGN: Randomized controlled trial. LEVEL OF EVIDENCE: Level 2. METHODS: We conducted a 2-centered, blinded, randomized controlled trial comparing the level of pain in patients undergoing arthroscopic repair. Patients were randomized to either PRP or saline (placebo). They received 2 ultrasound-guided injections of the randomized product: 1 intraoperatively and 1 at 4 weeks postoperatively. The primary outcome measure was shoulder pain demonstrated using a visual analog scale (VAS) at 6 weeks postoperatively. Secondary outcomes included the EuroQol-5 Dimensions (EQ-5D); the Western Ontario Rotator Cuff Index (WORC); and the Disabilities of the Arm, Shoulder, and Hand Score (DASH), as well as adverse events and revision surgeries. Patients were assessed clinically preoperatively and at 2, 4, and 6 weeks postsurgery. A prespecified interim analysis was conducted after 50% of patients were recruited and followed. RESULTS: We recruited 25 patients when interim power analysis led to an early trial termination. Follow-up was 96%. The mean difference between groups was not statistically significant (-1.81; 95% CI, -4.3 to 1.2; P = 0.16). The EQ-5D, WORC, and DASH scores also did not show significant differences between groups at week 6 (P = 0.5, 0.99, and 0.9, respectively). There were no revision surgeries, and 4 adverse events (3 PRP, 1 saline). CONCLUSION: There was no statistical difference in outcome measures when augmenting arthroscopically repaired RC tears with PRP. CLINICAL RELEVANCE: Identifying therapies that improve outcomes in patients with RC tears remains a challenge and deserves ongoing investigation.

Ethical and Methodological Issues Surrounding the Use of Appropriate Comparators in Orthopaedic Surgery Randomized Controlled Trials.

Although randomized controlled trials (RCTs) have the ability to provide researchers with more concrete evidence than that of their nonrandomized counterparts, conducting an RCT brings with it many ethical and methodological considerations. It is understood that in order to progress knowledge, and create new knowledge to benefit future patients, research must include human subjects; however, the desire to further knowledge must be placed second to the safety and respect for trial participants. An important ethical and methodological step in the design of any trial once the intervention is established is the selection of the comparator treatment. This is especially a topic of interest in orthopaedic surgery trials, in which a placebo comparator is not always possible and, arguably, sometimes never ethical. We review the use of different comparators in the treatment of orthopaedic surgery injuries and conditions, taking into consideration methodological and ethical issues. Comparators assessed are established treatments, standard-of-care treatments, conservative treatments, placebos, and sham surgeries.

Conflict of interest reporting in dentistry randomized controlled trials: a systematic review.

OBJECTIVES: Conflict of interest (COI) reporting in the medical field has been a concern for a number of years. As the impact of industry on medical research increases, the need for transparency in these relationships increases. In this present study we aim to assess current practices and associations for COI reporting in the field of dentistry. STUDY DESIGN: We conducted a systematic review of conflict of interest reporting for randomized controlled trials (RCTs) in 6 journals of Dentistry published between Jan 2011 and Mar 2012. We extracted study characteristics in duplicate and used descriptive statistics and Chi-square tests to assess associations. RESULTS: Of 1755 studies across seven journals, we identified 66 eligible RCTs. Many included studies were conducted in Europe (39%), with an average sample size of 355. A total of 76% of studies mentioned the presence or absence of potential COI. No correlation between the direction of results and whether a COI was declared was found (p = 0.328), nor was there an association between funding source and whether COI was discussed (p = 0.120). The journal in which the article was published did however have a correlation as to whether COI was discussed (p ≤ 0.0001). CONCLUSIONS: RCTs published in the field of dental research inconsistently report the presence or absence of a conflict of interest. Dental journals should standardize conflict of interest reporting to aid dental researchers in understanding when a conflict of interest exists, and to provide transparency to readers and patients alike.

Radiographic union score for hip substantially improves agreement between surgeons and radiologists.

BACKGROUND: Despite the prominence of hip fractures in orthopedic trauma, the assessment of fracture healing using radiographs remains subjective. The variability in the assessment of fracture healing has important implications for both clinical research and patient care. With little existing literature regarding reliable consensus on hip fracture healing, this study was conducted to determine inter-rater reliability between orthopedic surgeons and radiologists on healing assessments using sequential radiographs in patients with hip fractures. Secondary objectives included evaluating a checklist designed to assess hip fracture healing and determining whether agreement improved when reviewers were aware of the timing of the x-rays in relation to the patients' surgery. METHODS: A panel of six reviewers (three orthopedic surgeons and three radiologists) independently assessed fracture healing using sequential radiographs from 100 patients with femoral neck fractures and 100 patients with intertrochanteric fractures. During their independent review they also completed a previously developed radiographic checklist (Radiographic Union Score for Hip (RUSH)). Inter and intra-rater reliability scores were calculated. Data from the current study was compared to the findings from a previously conducted study where the same reviewers, unaware of the timing of the x-rays, completed the RUSH score. RESULTS: The agreement between surgeons and radiologists for fracture healing was moderate for "general impression of fracture healing" in both femoral neck (ICC = 0.60, 95% CI: 0.42-0.71) and intertrochanteric fractures (0.50, 95% CI: 0.33-0.62). Using a standardized checklist (RUSH), agreement was almost perfect in both femoral neck (ICC = 0.85, 95% CI: 0.82-0.87) and intertrochanteric fractures (0.88, 95% CI: 0.86-0.90). We also found a high degree of correlation between healing and the total RUSH score using a Receiver Operating Characteristic (ROC) analysis, there was an area under the curve of 0.993 for femoral neck cases and 0.989 for intertrochanteric cases. Agreement within the radiologist group and within the surgeon group did not significantly differ in our analyses. In all cases, radiographs in which the time from surgery was known resulted in higher agreement scores compared to those from the previous study in which reviewers were unaware of the time the radiograph was obtained. CONCLUSIONS: Agreement in hip fracture radiographic healing may be improved with the use of a standardized checklist and appears highly influenced by the timing of the radiograph. These findings should be considered when evaluating patient outcomes and in clinical studies involving patients with hip fractures. Future research initiatives are required to further evaluate the RUSH checklist.

Cost-effectiveness and economic impact of the KineSpring® Knee Implant System in the treatment of knee osteoarthritis in the United Kingdom.

BACKGROUND: Knee osteoarthritis (OA) is a condition affecting 8.5 million individuals in the United Kingdom (UK). Although many treatment options are available, there is a need for a less-invasive treatment for individuals with mild to moderate knee OA. The purpose of the present study was to determine whether the KineSpring System is a more effective treatment for knee OA when compared to other standard treatments, taking into consideration cost-utility ratios. METHODS: Data was collected for the UK population breakdown. A literature search provided data on conservative and surgical treatment costs and functional outcome scores. The KineSpring System outcome scores were obtained from two trials. Quality-adjusted life years (QALYs) gained and cost-utility ratios were calculated for each treatment option, assuming a lifetime durability as well as 10-year durability. RESULTS: Assuming lifetime durability, the cost-utility ratios of surgical treatment, total knee arthroplasty (TKA), the KineSpring System, and conservative treatments, compared to no treatment are £1,303±22/QALY, £821±175/QALY, £796±73/QALY and £11,096±1188/QALY, respectively. Assuming a treatment durability of 10 years, the cost-utility ratio of surgical treatment, TKA, the KineSpring System, and conservative treatments, compared to no treatment are £4,153±95 per QALY, £2,698±768 per QALY, £2,848±345 per QALY, and £10,624±1528 per QALY, respectively. CONCLUSION: This study demonstrates that the KineSpring System is a cost-effective treatment for knee OA and is comparable to current standard-of-care treatments. Further research is needed to assess the long-term outcomes associated with the KineSpring System.