M00-M99 S00-T98
Conditions
Interventions
Group 1: Arm 1- Standard therapy + Intervention
Patients in this arm receive 9 units of MBST therapy during their 7-day inpatient stay (following endoprosthesis implantation). One unit of MBST therapy has a duration of 60 minutes.
Group 2: Arm 2- S
Sponsors
MedTec Medizintechnik GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patient is at least 18 years old - Patient is scheduled for implantation of a total knee joint endoprosthesis - Patient is able to understand the nature, meaning and significance of his decision to participate in this study to recognize - Patient has given informed consent for study participation and data processing according to DSGVO signed - Compliance with the instructions for use of the MBST® ARTHRO-SPIN-FLEX
Exclusion criteria
Exclusion criteria: Implanted infusion, pain and insulin pumps; Cochlear implants and other implanted neurostimulators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Range of Motion (ROM) evaluate at visit 2, 3, 4, 5, 6 and 7; The investigator conduct this clinical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Questionnaire: Oxford Knee Score (OKS) at Visit 1, 2, 3, 4, 5, 6 and 7; - Questionnaire: Knee Injury Osteoarthritis Outcome Score (KOOS) at Visit 1, 2, 3, 4, 5, 6 and 7; - Questionnaire: Knee Society Score at Visit 1, 2, 3, 4, 5, 6 and 7; - Questionnaire: EQ-5D at Visit 1, 2, 3, 4, 5, 6 and 7; - Questionnaire: NRS Pain scale at Visit 1, 2, 3, 4, 5, 6 and 7; - Safety: Incidents, side effects | — |
Countries
Germany
Contacts
Public ContactLars;Daniela Stephan;Penn
Sportorthopaedie Dresden;medXteam GmbH
Outcome results
None listed