M17.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Indication for primary total knee arthroplasty due to primary or secondary osteoarthritis Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Neurological or musculoskeletal conditions that impair mobility independent of knee pathology Requirement for revision surgery Contraindications for a femoral pain catheter (e.g., coagulation disorders, infection at the puncture site) Cognitive impairment preventing reliable data collection (MMST < 24)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of early functional mobility assessed by a modified telephone-based 6-minute walk test at 6 weeks postoperatively. This parameter is evaluated preoperatively, at discharge (day 5–7), and during telephone follow-ups at weeks 6, 12, 26 and 52. Data are collected through standardized structured telephone interviews assessing walking distance, walking time, and joint function. Pain intensity (NRS 0–10 at rest and during movement) is recorded simultaneously as a supportive primary parameter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction assessed through the modified Knee Society Score (m-KSS) and the Forgotten Joint Score (FJS-12). Health-related quality of life measured by the telephone versions of SF-12 and EQ-5D at all follow-ups (weeks 6, 12, 26 and 52). Functional daily living abilities assessed by the modified Barthel Index and structured telephone interviews. Analgesic consumption recorded via standardized telephone interview. Postoperative complications (Clavien-Dindo classification), revision surgeries and length of hospital stay. | — |
Countries
Germany
Contacts
Kreiskliniken Herford-Bünde