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Pilot study for the evaluation of postoperative morbidity based on the POMS and collection of patient-related basic data after knee arthroplasty procedures

Pilot study for the evaluation of postoperative morbidity based on the POMS and collection of patient-related basic data after knee arthroplasty procedures - Pilot study TKA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034670
Enrollment
237
Registered
2024-10-30
Start date
2024-11-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective knee arthroplasty surgeries

Interventions

Group 1: The observational group consists of patients after elective knee arthroplasty surgeries. Data collection will take place from summer 2024 to summer 2027. The respective study duration per pat

Sponsors

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Klinik für Anästhesiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Ability to give consent - Present written informed consent of the study participants - Elective knee arthroplasty surgery

Exclusion criteria

Exclusion criteria: - Age <18 years - Current pregnancy - Absence of informed consent - Inability to give informed consent - Emergency patients

Design outcomes

Primary

MeasureTime frame
Assessment of POMS on the 1st, 3rd, 5th, and 8th postoperative day following knee arthroplasty procedures. The POMS is used to assess short-term postoperative morbidity. It consists of 9 categories that represent the various relevant organ systems and most common reasons for postoperative morbidity. Pulmonary, renal, hematologic, gastrointestinal, cardiovascular, and neurological complications, as well as pain, infections, and wound healing complications are considered. Each category determines the presence or absence of organ-specific postoperative complications.

Secondary

MeasureTime frame
- Prospective collection of basic data on the current patient population (including pain scale, performance, mobility) - Prospective survey of the Clavien-Dindo Score - Retrospective collection of basic data on the patient population (including pain scale, performance, mobility) - retrospective survey of the Clavien-Dindo Score - Exploratory analysis of the data collected in PROMISE regarding additional standardised rehabilitation scores - Validation of the POMS for knee arthroplasty procedures

Countries

Germany

Contacts

Public ContactGunther Pestel

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Klinik für Anästhesiologie

pestel@uni-mainz.de0049 6131 17-7175

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026