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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/107502
• EU PAS number:
  EUPAS107501
• Study ID:
  107502
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The objective of this study is to perform a comprehensive real-world evidence cross-sectional evaluation of the bio-psycho-social profile (i.e. patient burden) of patients with end-stage painful osteoarthritis of the knee and a given recommendation for total knee arthropasty (TKA) who took the opportunity of the second opinion (SO) program of the IMC to reevaluate the rationality and to improve the risk-benefit probability of the surgical intervention – based on data gathered via the German Pain e-Registry as part of the standardized interdisciplinary evaluation process IVZ-G according to the standards defined in the quality assurance agreement for specialized pain management (QST, § 138 SGB V) and following the recommendations of the German Pain Association and the German Pain League.
• Study status:
  Finalised

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned: 14/07/2023

Actual: 14/07/2023

Study start date

Planned: 17/07/2023

Actual: 17/07/2023

Data analysis start date

Planned: 21/08/2023

Actual: 21/08/2023

Date of final study report

Planned: 03/11/2023

Actual: 03/11/2023

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Grunenthal, Institute of Neurological Sciences

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable