Needle aspiration of calcific deposits versus shock wave therapy for conservative therapy resistant calcifying tendinitis of the shoulder: protocol of a randomized, controlled trial.

BACKGROUND: Calcific tendinitis of the shoulder (CT) is a common disorder with a large disease burden. The initial treatment is with conservative measures. However, when this fails the next step treatment remains unclear. Minimal invasive treatment modalities have emerged. Needle aspiration of the calcific deposits (NACD) and extracorporeal shock wave therapy (ESWT) have both shown good clinical results. Nonetheless, in the current orthopedic literature there are not any studies available that compare both the effectiveness and cost-effectiveness of those two treatment modalities. Therefore, our primary objective is to compare the effectiveness of NACD to ESWT. A secondary objective is to compare the cost-effectiveness of both treatment modalities and workability. METHODS: Following a power calculation using the minimal clinical important difference of our primary outcome (Constant-Murley score, CMS) 140 patients will be included in the study. Enrolment is based upon strict inclusion/ exclusion criteria outlined in the Methods section. Participants will be randomized by computer in two groups (e.g. 70 patients will receive NACD and 70 patients will receive ESWT). The NACD treatment will consist of a sonographically guided removal of the calcific deposits and the ESWT treatment will be a focused ESWT. Both treatments will be conducted according to a standardized protocol, as part of care as usual in our hospital. The primary outcome will be the between group differences in functional outcome (measured with the CMS) between baseline and after 12 months follow-up. Secondary outcomes will be questionnaires regarding the clinical outcome (SST) and quality of life (EQ-5D-5L). Furthermore, NRS pain and cost related questionnaires (iPCQ and ProDisQ) will be collected during follow-up after two months, six months and at final follow-up after 12 months. DISCUSSION: This study will provide more insight regarding treatment for conservative therapy resistant calcific tendinitis of the shoulder by comparing NACD to focused ESWT, which will aid the physician and patient in determining the appropriate treatment plan. TRIAL REGISTRATION: Dutch trial register: NTR7093 registered on 11 March 2018.

Translation and evaluation of psychometric properties of the Dutch version of the Single Assessment and Numeric Evaluation Method (SANEM) in shoulder patients.

BACKGROUND: The Single Assessment Numeric Evaluation Method (SANEM) is a holistic patient-reported outcome measure (PROM) that includes all aspects involving the shoulder. It is simple and easy to administer. It consists of only one question, namely how would you rate your shoulder today as a percentage of normal (0 to 100% with 100% being normal)? The purpose of this study was to translate the SANEM in Dutch and to assess its construct validity, reliability, and responsiveness. METHODS: The SANEM was translated into Dutch using forward and backward translation. Hypothesis testing was used to determine construct validity and responsiveness, 75% needed to be confirmed. Previous validated PROMs were used as comparator instrument for testing construct validity. Test-retest reliability (2-week interval), Standard Error of Measurement, and Smallest Detectable Change were calculated as reliability analyses. One year after baseline, we evaluated the responsiveness. RESULTS: One hundred seven patients (55% women) with a mean age of 54 years were included. Of the hypotheses formed in advance to assess construct validity, 67% was confirmed, meaning there was no adequate construct validity and the SANEM cannot replace all other PROMs. With an intraclass correlation coefficient of 0.95, excellent test-retest reliability was found. Of the hypotheses formed in advance to evaluate the responsiveness, 75% was confirmed, indicating the SANEM has good responsiveness. CONCLUSION: Although the SANEM cannot replace all other PROMs, it is a reliable instrument to assess if a patients' shoulder, regarding the whole shoulder, changes over time or stays unchanged. LEVEL OF EVIDENCE: Level II.

Evaluation of wound healing after total knee arthroplasty in a randomized prospective trial comparing fondaparinux with enoxaparin.

BACKGROUND: Fondaparinux, a new synthetic pentasaccharide has proven to be a more potent thromboprophylactic drug compared to enoxaparin after major orthopaedic surgery. However, the safety of fondaparinux regarding wound healing has not yet been investigated. METHODS: We performed a single-centre prospective clinical trial, in which patients undergoing total knee arthroplasty or revision of at least one of the components of a previous knee arthroplasty were randomly assigned to thromboprophylaxis with fondaparinux or enoxaparin. The trial included 109 patients and wound discharge was compared. Secondary outcome measures were the amount of blood in the suction drain, postoperative transfusion rate, change in haemoglobin levels, haematocrit, intervention rate, time to regain flexion and rate of symptomatic thromboembolic events. RESULTS: 55 patients were treated with fondaparinux and 54 with enoxaparin. Base-line characteristics were similar. In both groups wound dressings remained dry after five (5.17+/-2.5 and 5.19+/-3) days postoperatively. There were no significant differences in any of our outcome measures. CONCLUSIONS: We did not find any significant difference in wound healing with fondaparinux after major knee surgery. Post hoc analyses suggested the study should have had a sample size of 155 in each group. We believe this trial should be used as a pilot study for further investigations concerning the safety of thromboprophylaxis.