Status:
COMPLETED
Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia
Lead Sponsor:
Riku Antero Palanne
Collaborating Sponsors:
Helsinki University Central Hospital
University of Helsinki
Conditions:
Knee Osteoarthritis
Arthropathy of Knee Joint
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Previous retrospective database studies suggest that total knee arthroplasty (TKA) surgery under spinal anesthesia has less complications than when performed under general anesthesia. In general, comp...
Eligibility Criteria
Inclusion
- Indication for total knee arthroplasty exists (patient has osteoarthritis, rheumatoid arthritis or other disease affecting knee joint that does not respond to conservative treatment)
- Patient understands the study information and is willing to participate
- Triathlon endoprosthesis is suitable for patient
- ASA Physical Status Classification 1-3
- Patient will be operated by a surgeon who has done at least 100 total knee arthroplasty procedures with Triathlon endoprosthesis before
Exclusion
- BMI \> 40 kg/m2
- ASA Physical Status Classification \> 3
- Valgus or varus \> 15° degrees in the knee that will be operated
- Extension deficit ≥ 20° or flexion ≤ 90° in the knee that will be operated
- Earlier major (open) surgery in the knee that will be operated
- Contraindication for drugs used in the study
- Contraindication for either spinal or general anesthesia
- Glomerular filtration rate \< 60ml/min/1.73m2 (by Chronic Kidney DIsease Epidemiology Collaboration formula)
- Known or suspected disease affecting the function of liver
- Preoperative use of strong opioids
- Patient is pregnant, cognitively disabled, under guardianship, a prisoner or in compulsory military service
- Patient will be operated by a surgeon who has done less than 100 total knee arthroplasty procedures before or by a surgeon who does not operate with Triathlon endoprosthesis
- Day of the surgery is not suitable for study (no research personnel available for 24 hours postoperative evaluation)
Key Trial Info
Start Date :
October 3 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT03364088
Start Date
October 3 2016
End Date
December 3 2019
Last Update
January 13 2020
Active Locations (1)
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1
Helsinki University Central Hospital, Peijas hospital
Vantaa, Finland, 00029