Implementation of a new treatment scheme for primary knee prosthesis implantations in the German health care system in collaboration with DRV
- Conditions
- Patient with advanced osteoarthritis and indication for endoprosthetic joint replacement of the knee joint (knee TEP)
- Registration Number
- DRKS00032695
- Lead Sponsor
- Medizinische Hochschule Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Indication for primary implantation of a total knee joint endoprosthesis
- Age: 18 - 80 years
- Patient is gainfully employed
- ASA 3-6
- BMI > 34 kg/m2
- Diabetes mellitus with blood glucose imbalances (hypoglycemias)
- Chronic renal insufficiency with GFR < 60 (stage III according to NKF)
- Coronary artery disease with Z.n. intervention within the last 2 years or further complaints
- Permanent anticoagulation with heart valve replacement
- Dementia or other neurological diseases with alteration of gait (Parkinson's syndrome, myasthenia gravis, visual pathway disorders, etc.)
- Anemia/hemophilia/thrombophilia with secondary DVT/LAE
- Known depression/psychoaffective disorder
- Chronic pain patient with long-term opioid medication/fibromyalgia
- Rheumatoid arthritis with expected limitation in postoperative mobilization
- COPD with limitations in daily living/sleep apnea syndrome
- Massive ROM deficit
- Lack of compliance for complex treatment procedures
- Language barrier
Subsequent exclusion from clinical trial:
- Loss of assignment to OptiTrack Athletic group and continued treatment according to standard (time: until discharge).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the Knee Injury and Osteoarthritis Score including Western Ontario and McMaster Universities Osteoarthritis Index (KOOS including WOMAC) score after 3 months, reflecting the functionality and quality of life of patients who underwent two different treatment regimens. <br>We expect a superiority, in terms of postoperative outcome, of the Athletic group over the Classic group. The study will be considered successful if this superiority can be demonstrated.
- Secondary Outcome Measures
Name Time Method - Acquisition and comparison KOOS six, twelve and 24 months postoperatively<br>- Acquisition of PROMS University of California Los Angeles Activity Score (UCLA), Oxford Knee Score (OKS), Knee Society Score (KSS), Forgotten Joint Score (FJS), European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), Chronic Pain Grade according to von Korff ( CPG n. v. Korff), Depression Anxiety Stress Scales (DASS)<br>- Assessment of pain via Visual Analog Scale (VAS)<br>- Measurement of the knee joint extension force (M. quadriceps femoris) via dynamometer<br>- Recording of postoperative complications<br>- Recording of the readmission rate<br>- Assessment of the effect of the two treatment regimens on obesity, diabetes mellitus type II, chronic pain syndrome<br>- Assessment of the effects of the two treatment regimens on the time of complete reintegration into the profession or on the time of resumption of the profession or occupation, respectively.