Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for people with end-stage knee osteoarthritis (worn-out knee joint) that causes symptoms. It compares robot-assisted and standard knee replacement surgery.

Életkor

50 Years and older

Nem

All sexes

A betegség stádiuma

Symptomatic end-stage primary knee osteoarthritis (wear-and-tear arthritis not caused by injury or infection).

Korábbi kezelés

People who had major knee surgery before, such as high tibial osteotomies (HTO) or osteosynthesis, cannot join. Surgery that does not change the joint line, such as knee arthroscopy (meniscal repair), is allowed.

A részvétel fő kizáró okai

• Body mass index (BMI) > 40 kg/m²
• Severe knee deformity: >20° varus, >15° valgus or >15° flexion deformity
• Knee arthritis after injury or infection, or significant osteoporosis or bone loss
• ASA score more than stage 3, or poorly controlled diabetes or high blood pressure
• Infection that must be treated first, such as dental caries, chest infection or diabetic foot

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Total knee arthroplasty (TKA) remains the definitive treatment for advanced knee osteoarthritis and continues to be performed with increasing frequency worldwide. However, patient dissatisfaction remains reported in up to one-fifth of cases, despite technically successful procedures and acceptable radiographic results. This discrepancy has shifted attention toward early functional recovery and patient-reported outcomes as more meaningful indicators of success. In response, technological innovations such as robotic-assisted total knee arthroplasty have been introduced to enhance surgical precision and reduce alignment outliers. This study aims to determine whether these technical advantages translate into improved early clinical outcomes by comparing patient satisfaction, functional results, radiological accuracy, and perioperative parameters between robotic-assisted and conventional total knee arthroplasty over one year.

A vizsgálat 2 csoportja

• Mako4 Robotic Arm Assisted Total Knee ArthroplastyA vizsgált kezelés

  All patients will be managed by the same surgical team , performed with the patient in supine position. Prophylactic intravenous antibiotics will be administered 30 minutes before skin incision , using weight-adjusted dosing. An above-knee pneumatic tourniquet will be applied in all cases, and a standard medial parapatellar approach will be used. Patients allocated to the robotic-assisted group will undergo total knee arthroplasty using the Mako Robotic-Arm Assisted System (Stryker, Kalamazoo, Michigan, USA) with the Triathlon Total Knee System. Robotic assistance will be used for preoperative/intraoperative surgical planning, bone preparation, component positioning, and intraoperative assessment of soft-tissue balance. In both groups, all components will be implanted using cemented fixation. Stem extensions may be used selectively on a case-by-case basis.The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.

• conventional total knee arthroplasty using Triathlon Total Knee SystemMár használt kezelés, összehasonlításként

  All patients will be managed by the same surgical team , performed with the patient in supine position. Prophylactic intravenous antibiotics will be administered 30 minutes before skin incision , using weight-adjusted dosing. An above-knee pneumatic tourniquet will be applied in all cases, and a standard medial parapatellar approach will be used. Patients allocated to the conventional (control) group will undergo total knee arthroplasty using the Triathlon Total Knee System (Stryker, Kalamazoo, Michigan, USA) with standard manual instrumentation and conventional cutting jigs, without robotic assistance. Component sizing, bone preparation, positioning, and soft-tissue balancing will be performed using standard conventional techniques. All components will be implanted using cemented fixation. Stem extensions may be used selectively on a case-by-case basis. The patella will be managed with conventional patelloplasty in all patients. Closed-suction drains will be used routinely.