Pain characteristics of patients recommended total knee arthroplasty due to painful osteoarthritis – a cross-sectional analysis of depersonalized real-world data of the German Pain e-Registry to evaluate the bio-psycho-social profile/burden of patients participating in an interdisciplinary second opinion program prior surgery (PACE-1)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2108

Study design details

• Main study objective:
  The primary objective of this exploratory study is to identify characteristic biopsychosocial features of patients with pOAK who are referred for TKA.
• Data analysis plan:
  Data analyses will be performed for the complete set of anonymized data provide by the GPeR according to the given in- and exclusion criteria (see below). Descriptive statistical analyses will be performed as reported. For continuous variables, descriptive statistics will be summarized by the number of patients (n), the mean, standard deviation (SD), 95% confidence intervals (95%-CI) of the mean, median, and range (minimum – maximum) values. For categorical and ordinal variables data will be summarized by frequency number (n), percentage (%) and (where appropriate) adjusted percentage (a%) of participants in each category, incl. 95% confidence intervals. As this project follows is a purely exploratory/descriptive approach, no confirmatory procedures will be applied. Only one data lock is planned for this study, when the anonymized data sets will be completely extracted from the GPeR.