Effectiveness of standardized ultrasound guided percutaneous treatment of lateral epicondylitis with application of autologous blood, dextrose or perforation only on pain: a study protocol for a multi-center, blinded, randomized controlled trial with a 1 year follow up.

BACKGROUND: In the treatment of Lateral Epicondylitis (LE) no single intervention concerning injection therapies has been proven to be the most effective with regard to pain reduction. In this trial 3 injection therapies (perforation with application of autologous blood, perforation with application of dextrose and perforation only) will be compared in a standardized and ultrasound guided way. The objective is to assess the effectiveness of these 3 injection therapies on pain, quality of life and functional recovery. By conducting this study, we hope to make a statement on the effectiveness of injection therapy in the treatment of LE. Hereby, unnecessary treatments can be avoided, a more universal method of treatment can be established and the quality of the treatment can be improved. METHODS/DESIGN: A multicenter, randomized controlled trial with a superiority design and 12 months follow-up will be conducted in four Dutch hospitals. One hundred sixty five patients will be recruited in the age of 18 to 65 years, with chronic symptomatic lateral epicondylitis lasting longer than 6 weeks, which have concordant pain during physical examination. Patients will be randomized by block randomization to one of the three treatment arms. The treatment will be blinded for patients and outcome assessors. The following three injection therapies are compared: perforation with application of autologous blood, perforation with application of dextrose and perforation only. Injections will be performed ultrasound guided in a standardized and automated way. The primary endpoint is: pain (change in 'Visual Analogue Scale'). Secondary endpoints are quality of life and functional recovery. These measurements are collected at baseline, 8 weeks, 5 months and 1 year after treatment. DISCUSSION: When completed, this trial will provide evidence on the effectiveness of injection therapy in the treatment of lateral epicondylitis on pain, quality of life and functional recovery. In current literature proper comparison of the effectiveness of injectables for LE is questionable, due to the lack of standardization of the treatment. This study will overcome bias due to manually performed injection therapy. TRIAL REGISTRATION: This study is registered in the Trial Register ( www.trialregister.nl ) of the Dutch Cochrane centre. Trial ID; NTR4569. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4569.

Eight respectively nine out of ten patients return to sport and work after distal femoral osteotomy.

PURPOSE: Distal femoral osteotomy (DFO) is a well-accepted procedure for the treatment of femoral deformities and associated symptoms including osteoarthritis, especially in younger and physically active patients in whom knee arthroplasty is undesirable. Still, there is an apparent need for evidence on relevant patient outcomes, including return to sport (RTS) and work (RTW), to further justify the use of knee osteotomy instead of surgical alternatives. Therefore, the purpose of the present study was to investigate the extent and timing of patients' RTS and RTW after DFO. METHODS: This monocentre, retrospective cohort study included consecutive DFO patients, operated between 2012 and 2015. Out of 126 eligible patients (18-70 years, 63% female), all patients responded, and 100 patients completed the questionnaire. Median follow-up was 3.4 years (range 1.5-5.2). The predominant indication for surgery was symptomatic unicompartmental osteoarthritis and valgus or varus leg alignment caused by a femoral deformity. The primary outcome measure was the percentage of RTS and RTW. Secondary outcome measures included time to RTS/RTW, sports level and frequency, the median pre-symptomatic and postoperative Tegner activity score (1-10, higher is more active) and the postoperative Lysholm score (0-100, higher is better). RESULTS: Out of 84 patients participating in sports preoperatively, 65 patients (77%) returned to sport postoperatively. Forty-six patients (71%) returned to sports within 6 months. Postoperative participation in high-impact sports was possible though less frequent compared to preoperative participation. Out of 80 patients working preoperatively, 73 (91%) returned to work postoperatively, of whom 59 patients (77%) returned within 6 months. The median pre-symptomatic Tegner activity score [4.0 (range 0-10)] was significantly higher (p < 0.01) than the reported Tegner score at follow-up [3.0 (range 0-10)]. The mean Lysholm score at follow-up was 68 (± 22). No significant differences were found between the osteoarthritis- and non-osteoarthritis group. CONCLUSION: Eight out of ten patients return to sport and nine out of ten patients return to work after DFO. These are clinically relevant findings, because they further justify DFO as a surgical alternative to KA in young, active knee OA patients who wish to return to high activity levels. LEVEL OF EVIDENCE: Retrospective cohort study, Level III.