Mobilisation after Primary Total Knee Replacement M25.46
Conditions
Interventions
Group 1: Use of electronic-balanced energy extraction (study device - CTS 100)
DOS: 1x 60 min., 1x 180 min.
1. d postop2x 120 min.
2. + 3. d postop 3x 60 min.
Group 2: Use of cryotherapy (control dev
Sponsors
Sevika Medical AG
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subject is between 60 and 80 years old 2. Men and women 3. Subject is candidate for non-navigated unilateral Primary Total Knee Replacement (PTKR) with the NexGen® System (fixed bearing only) performed by a mid-vastus approach who suffer from non-inflammatory knee disease, such as degenerative gonarthrosis, post-traumatic gonarthrosis, or osteonecrosis. 4. Subject agrees to comply with the required postoperative management and follow-up evaluations 5. Subject has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) > 40. 2. Acute fracture, inflammatory osteoarthritis, rheumatoid arthritis or tumour at the relevant knee 3. Previous surgery at the relevant knee other than arthroscopy 4. Previous surgical site infection or active systemic infection (HIV, Hepatitis B or C infection ) 5. History of active malignancy within the last 5 years 6. Patients suffering from allergies or intolerance to cold 7. Patients with suspected Raynaud disease 8. Patients with cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, or any disease which produces a marked cold pressor response 9. Decreased skin sensitivity 10. Compromised local circulation 11. Fibromyalgia or other chronic pain syndrome 12. Intake of medication that interfere with the immune system (e.g. corticoids, interferons, TNF antagonists), high dose non-steroidal anti-inflammatory drugs 13. Pharmaceutical or other drug abuse; alcoholism 14. Patient with other concurrent physical or mental conditions which are likely to affect the outcome 15. Pregnancy or potential to pregnancy without adequate anticonception 16. Patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule. 17. Patient who has not signed the Informed Consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Range of motion: average range of motion in degree during the first 3 days after surgery 2. Visual Analogue Scale (VAS) on severity of postoperative knee pain: total VAS measures in cm during the first 3 days after surgery 3. Subject eligible for discharge: first postoperative day, when the patient reaches >= 90° ROM and is able to climb stairs in the absence of an infection 4. Analgesic use: total doses per agent in mg/kg during the first 3 postoperative days 5. Visual Analogue Scale (VAS) on subjects satisfaction with postoperative cooling management: total VAS measures in cm during the first 3 days 6. Time management and cost analysis: hospital personals' time spent for therapy during hospital stay, hospital costs per day until subject is eligible for discharge and costs for pain medication during hospital stay | — |
Primary
| Measure | Time frame |
|---|---|
| Postoperative swelling of the relevant knee: mean knee circumference in cm 2. and 3. postop day | — |
Countries
Germany
Contacts
Public ContactSabine Mai
Vitos Orthopädische Klinik Kassel gGmbH
Outcome results
None listed