Escaping the Scalpel

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24 CHAPTER II Method Population This study was part of the ESCAPE trial, a noninferiority multicenter randomized controlled trial comparing arthroscopic partial meniscectomy with a nonoperatively treated control group receiving physical therapy.[24, 25] Between July 2013 and October 2015, 321 patients between 45 and 70 years of age with a symptomatic, nonobstructive, degenerative meniscal tear (confirmed per magnetic resonance imaging) were included. Exclusion criteria consisted of severe osteoarthritis (Kellgren-Lawrence 4), body mass index >35 kg/m2, locking of the knee, prior knee surgery, and knee instability attributed to anterior or posterior cruciate ligament rupture. Previous knee injuries (e.g., anterior cruciate ligament rupture) that can interfere with the treatment outcome were assessed on magnetic resonance imaging and excluded from the trial. Further details can be found in the study protocol.[25] The ESCAPE trial was approved by the Medical Ethical Committee (NL44188.100.13). All patients provided written informed consent for participation. Treatment Patients randomized to arthroscopic partial meniscectomy underwent surgery within 4 weeks after enrollment. The arthroscopic partial meniscectomy procedure started with a general assessment of the joint, whereupon the affected meniscus was partially removed, resulting in a stable and solid meniscus. Patients received standard written postoperative instructions. Participants were referred to physical therapy after arthroscopic partial meniscectomy if rehabilitation was not going according to the guideline of the Dutch Orthopaedic Association.[23] Physical therapy started 1 to 2 weeks after randomization. Patients in the physical therapy group participated in a supervised progressive exercise program consisting of 16 sessions of 30 minutes each (Appendix 1).[25] Data Collection Patients received self-administered questionnaires at baseline and 6 months after enrollment. Patients completed the questionnaires at home, either online or on paper. In the online questionnaires, no data were missing, as completion of each item was required to move on to the next item. When an item was missing in the paper-based questionnaires, the missing item was obtained by telephone. To enhance the response rate, up to 3 response reminders were sent to the patients. Details on patient inclusions, randomization, and follow-up are available in Appendix 2.
RESPONSIVENESS AND MINIMAL IMPORTANT CHANGE OF THE IKDC25 Table 1. Hypotheses with expected and calculated correlations Hypothesis Expected r Calculated r (95% CI) P Value 1 The change in total IKDC score shows at least a very strong positive correlation with the change on the PCS of the RAND-36 ≥0.7 0.74 (0.67 – 0.81)
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Chapter 7 General Discussion
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Chapter 9 Appendices
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APPENDICES139 Appendix 1 Physical t
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154 CHAPTER X List of publications
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