A Phase 3 interventional study of total knee arthroplasty in Osteoarthritis, Knee, sponsored by Police General Hospital, Thailand. Active, not recruiting at 1 site in Thailand. Open to participants aged 58 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Police General Hospital, Thailand · Phase 3, Interventional, and Treatment
Total knee arthroplasty (TKA) is a successful treatment for end-stage osteoarthritis of the knee. The main advantages of TKA are to relieve the pain of the knee, improve the knee function, restore lower limb alignment, and improve the quality of life for patients. During TKA, some surgeons prefer using a scalpel while others using electrocautery to expose the articular cavity. Whether the use of scalpel can lead to better and faster recovery after the primary TKA is still controversial.
The aim of this study was to compare the clinical outcomes of using the scalpel and the electrocautery in primary TKA
A randomized controlled trial of patients underwent primary TKA between October 2021 and October 2023. The groups will be determined by using the computer to generate a randomization lists. A total 132 patients were included with 66 patients in the scalpel group, 66 patients in the electrocautery group. All patients were evaluated using primary outcome : Post-operative Visual Analog Scale (VAS) of pain, secondary outcome: estimated blood loss and Knee Injury and Osteoarthritis Outcome Score (KOOS-JR)
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 132 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Police General Hospital, Thailand is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proceed with following step 1. Using electrocautery for stop bleeding at subcutaneous tissue layer 2. In deep layer still use scalpel for Remove anterior cruciate ligament and posterior cruciate ligament 3. Soft tissue removal and synovial tissue removal 4. No patellar denervation
Procedure: total knee arthroplasty
Using an electrocautery in following step 1. Stop bleeding at subcutaneous tissue layer 2. Remove anterior cruciate ligament and posterior cruciate ligament 3. Bony mark for further bone cut 4. Patellar denervation 5. Soft tissue removal 6. Synovial tissue removal
Procedure: total knee arthroplasty
total knee arthroplasty surgery with Police Arthroplasty joint academy center(PAJAC) Subvastus Approach
Postoperative pain (visual analog scale) day 1-4
measure the Postoperative pain by using visual analog scale from 1 - 10, higher scores means worse outcome
Time frame: postoperative day 1-4
Calculated blood loss
Calculated blood loss using Mercuruali's formula
Time frame: postoperative day 4
Functional score
Functional score using KOOS JR score, range from 0 to 100 with a score of 0 indicating total knee disability and 100 indicating perfect knee health
Time frame: follow up 2 weeks, 1,3,6 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Police General Hospital, Thailand