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Comparing serum systemic inflammatory biomarkers in Robotic TKA vs Robotic UKA : A prospective randomized controlled trial

Comparing serum systemic inflammatory biomarkers in Robotic TKA vs Robotic UKA : A prospective randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260505001
Enrollment
60
Registered
2026-05-05
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serum systemic inflammatory biomarker response in patients with medial compartment knee osteoarthritis undergoing robotic-assisted total knee arthroplasty versus robotic-assisted unicompartmental knee arthroplasty serum systemic inflammatory biomarkers, inflammatory biomarkers, IL-6, ESR, CRP, CK, LDH, robotic-assisted total knee arthroplasty, robotic TKA, robotic-assisted unicompartmental knee arthroplasty, robotic UKA, unicompartmental knee arthroplasty, total knee arthroplasty, medial compar

Interventions

Patients in this arm will undergo primary robotic-assisted total knee arthroplasty for medial compartment knee osteoarthritis using robotic-arm guidance. The procedure includes full knee joint replace
Active Comparator Procedure/Surgery,Experimental Procedure/Surgery
Robotic-assisted Total Knee Arthroplasty TKA,Robotic-assisted Unicompartmental Knee Arthroplasty UKA

Sponsors

Research facilitation division Vajira hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 50-80 years at the time of surgery. 2. Patients diagnosed with medial compartment knee osteoarthritis who have failed conservative treatment for at least 6 months. 3. Patients undergoing primary knee arthroplasty, including primary total knee arthroplasty TKA or primary unicompartmental knee arthroplasty UKA

Exclusion criteria

Exclusion criteria: 1. Patients with inflammatory arthritis, such as rheumatoid arthritis or systemic lupus erythematosus SLE. 2. Patients with lateral compartment knee osteoarthritis. 3. Patients with flexion contracture greater than or equal to 15 degrees. 4. Patients with preoperative arc of motion less than 90 degrees. 5. Patients with severe angular deformity, including varus deformity greater than or equal to 10 degrees or valgus deformity greater than or equal to 5 degrees. 6. Patients with a history of bone tumors or active malignancy. 7. Patients with a history of previous fracture of the distal femur, patella, or proximal tibia. 8. Patients with active systemic or local infection, including sepsis, urinary tract infection, respiratory tract infection, or infection around the knee joint. 9. Patients with severe medical comorbidities unsuitable for anesthesia, defined as ASA classification IV-VI.

Design outcomes

Primary

MeasureTime frame
Serum systemic inflammatory biomarker levels Preoperative baseline within 1 month before surgery, postoperative Day 1, Day 3, Week 3, Week 8, and Year 1 after surgery Serum IL-6 ESR CRP CK and LDH levels measured by laboratory blood tests and compared between groups at predefined perioperative and postoperative time points.

Secondary

MeasureTime frame
Postoperative pain score Postoperative Day 1, Day 3, Week 3, Week 8, and Year 1 Visual Analog Scale VAS pain score assessment,Knee functional outcome Preoperative baseline, Week 3, Week 8, and Year 1 Knee Society Score KSS,Range of motion Preoperative baseline, Week 3, Week 8, and Year 1 Knee flexion and extension angle measured using goniometer,Radiographic alignment Postoperative period within routine radiographic follow-up Postoperative radiographic evaluation of femoral and tibial component alignment and posterior slope,Perioperative outcomes During surgery, postoperative hospitalization, and discharge period. Operative time, perioperative blood loss, and length of hospital stay from medical records

Countries

Thailand

Contacts

Public Contactboonyarit atjanapanya

Vajira hospital

boonyarit.atj@nmu.ac.th0654477718

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026