M17
Conditions
Interventions
Group 1: Intervention group (ERAS): Participants receive an Enhanced Recovery After Surgery (ERAS) protocol for primary cemented total knee arthroplasty (TKA). The protocol includes preoperative patie
Sponsors
Orthopädie Universität Regensburg (im Asklepios Klinikum)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Primary cemented, navigated total knee arthroplasty (TKA) for primary or secondary osteoarthritis. • Implantation of the P.F.C.™ Sigma knee prosthesis system (DePuy Synthes). • Surgery performed using the mechanical alignment technique. • Written informed consent.
Exclusion criteria
Exclusion criteria: • History of deep vein thrombosis. • Ongoing therapeutic anticoagulation. • Limited preoperative mobility (walking distance 50 kg/m². • Recent open surgery (excluding arthroscopy). • Concurrent participation in another clinical study. • Refusal or inability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery of isokinetic muscle strength within one year after primary total knee arthroplasty (TKA), assessed by: - Peak Torque - Total Work - Power | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcome measures (PROMs), including: - Range of Motion - Pain intensity (Numeric Rating Scale, NRS) - Self-perceived health - Expectation fulfilment - KOOS subscale scores (Knee injury and Osteoarthritis Outcome Score) | — |
Countries
Germany
Contacts
Public ContactJulia Schiegl
Orthopädie Universität Regensburg (im Asklepios Klinikum)
Outcome results
None listed