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1.  Efficacy of multimodal, systematic non-surgical treatment of knee osteoarthritis for patients not eligible for a total knee replacement: a study protocol of a randomised controlled trial 
BMJ Open  2012;2(6):e002168.
Introduction
It is recommended that non-operative treatment of knee osteoarthritis (KOA) should be individually tailored and include multiple treatment modalities. Despite these recommendations, no one has yet investigated the efficacy of combining several non-surgical treatment modalities in a randomised controlled study. The purpose of this randomised controlled study is to examine if an optimised, combined non-surgical treatment programme results in greater improvements in pain, function and quality of life in comparison with usual care in patients with KOA who are not eligible for total knee arthroplasty (TKA).
Methods and analysis
This study will include 100 consecutive patients from the North Denmark Region not eligible for TKA with radiographic KOA (K-L grade ≥1) and mean pain during the previous week of ≤60 mm (0–100). The participants will be randomised to receive either a 12-week non-surgical treatment programme consisting of patient education, exercise, diet, insoles, paracetamol and/or NSAIDs or usual care (two information leaflets containing information on KOA and advice regarding the above non-surgical treatment). The primary outcome will be the change from baseline to 12 months on the self-report questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living and quality of life. Secondary outcomes include the five individual KOOS subscale scores, pain on a 100 mm Visual Analogue Scale, EQ-5D, self-efficacy, pain pressure thresholds, postural control and isometric knee flexion and knee extension strength.
Ethics and dissemination
This study was approved by the local Ethics Committee of The North Denmark Region (N-20110085) and the protocol conforms to the principles of the Declaration of Helsinki. Data collection will be completed by April 2014. Publications will be ready for submission in the summer of 2014.
Trial registration number
This study is registered with http://clinicaltrials.gov (NCT01535001).
doi:10.1136/bmjopen-2012-002168
PMCID: PMC3533085  PMID: 23151395
Rheumatology; Rehabilitation Medicine
2.  Autologous Blood Transfusion after Local Infiltration Analgesia with Ropivacaine in Total Knee and Hip Arthroplasty 
Aims. To study the safety of autotransfusion following local infiltration analgesia (LIA) with ropivacaine. Background. Knowledge of blood concentrations of ropivacaine after LIA and autotransfusion is crucial. However, very limited data are available for toxicological risk assessment. Methods. Autotransfusion was studied in patients after total knee arthroplasty (TKA: n = 25) and total hip arthroplasty (THA: n = 27) with LIA using 200 mg ropivacaine, supplemented with two postoperative bolus injections (150 mg ropivacaine). Drainage blood was reinfused within 6 h postoperatively. Results. Reinfusion caused a significant increase in the serum concentration of total ropivacaine for TKA from 0.54 ± 0.17 (mean ± SD) to 0.79 ± 0.20 μg/mL (P < 0.001) and a nonsignificant increase for THA from 0.62 ± 0.17 to 0.63 ± 0.18 μg/mL. The maximum free (unbound) concentration after reinfusion was 0.038 μg/mL. Peak total and free venous ropivacaine concentrations after 8 h and 16 h postoperative bolus injections were 2.6 μg/mL and 0.11 μg/mL, respectively. All concentrations observed were below the threshold for toxicity and no side effects were observed. Conclusion. Autotransfusion of patients undergoing knee or hip arthroplasty after local infiltration analgesia with 200 mg ropivacaine can be performed safely, even supplemented with 8 h and 16 h postoperative bolus injections.
doi:10.1155/2012/458795
PMCID: PMC3420087  PMID: 22919377

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