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Completed

NCT Number: NCT06638047

Early Clinical and Radiological Outcomes of a Novel Robotic TKA System

This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.

144 patients undergoing primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes will include coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).

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Key information

Conditions

Total Knee Anthroplasty Robotic Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-85 years (including 18 and 85), regardless of gender;
  • Patients scheduled for unilateral primary total knee arthroplasty based on the clinical judgment of the study physician;
  • The subject or their guardian has been informed of the study, agrees to all terms of the trial, signs an informed consent form approved by the ethics committee, and agrees to participate in the trial.

Exclusion criteria

  • The side scheduled for surgery has significant hip joint disease, such as substantial bone defects or severe limitations in joint mobility;
  • Patients with active infections around the knee joint or systemic infections;
  • Discontinuity or severe functional loss of the knee extensor mechanism, painless knee joint fusion, Charcot joint, poor surgical tolerance, or other conditions that may adversely affect surgical prognosis;
  • Patients with contraindications for traditional TKA surgery;
  • Pregnant or breastfeeding women;
  • Patients known to have excessive alcohol consumption or substance abuse; Body mass index (BMI) > 35 kg/m²;
  • Patients who have participated in other clinical trials within one month prior to signing the informed consent form;
  • Patients with mental or intellectual disabilities that may affect clinical outcome evaluations;
  • Patients deemed unsuitable for participation in this clinical trial by the investigator.

Treatment and study plan

Robotic-assisted TKA

Procedure

Robotic-assisted TKA means that TKA surgery is operated with the guidance of robotic system.

CI-TKA

Procedure

TKA operated with conventional instruments

Primary outcomes

  1. HKA outliers

    Time frame: 12 weeks post-surgery

    the proportion of patients with a deviation of ≤ 3° between the mechanical axis (hip-knee-ankle angle, or HKA angle) measured from a full-length, frontal-view lower limb X-ray

Secondary outcomes

  1. FFC angle

    Time frame: 12 weeks post-surgery

    frontal femoral component (FFC) angle

  2. outliers of FFC angle

    Time frame: 12 weeks post-surgery

    outliers of frontal femoral component (FFC) angle (>3 degree)

  3. FTC angle

    Time frame: 12 weeks post-surgery

    frontal tibia component (FTC) angle

  4. outliers of FTC angle

    Time frame: 12 weeks post-surgery

    outliers of frontal tibia component (FTC) angle (>3 degree)

  5. LFC angle

    Time frame: 12 weeks post-surgery

    lateral femoral component (LFC) angle

  6. outliers of LFC angle

    Time frame: 12 weeks post-surgery

    outliers of lateral femoral component (LFC) angle (>3 degree)

  7. LTC angle

    Time frame: 12 weeks post-surgery

    lateral tibia component (LTC) angle

  8. outliers of LTC angle

    Time frame: 12 weeks post-surgery

    outliers of lateral tibia component (LTC) angle (>3 degree)

  9. Surgical duration

    Time frame: During operation

    In this study, surgical duration is defined as the time from the first incision to the completion of skin closure

  10. Blood loss

    Time frame: 3 days after surgery

    Postoperative blood loss is calculated using the Gross formula in this study. The Gross equation was used to calculate the total blood loss (mL) as preoperative blood volume×(preoperative HCT level-postoperative HCT level).

  11. ROM

    Time frame: 12 weeks post-surgery

    ROM refers to the maximum passive range of knee motion

  12. Knee Society Score (KSS)

    Time frame: screening and 12 weeks post-surgery.

    The KSS, developed by the American Knee Society, evaluates objective knee indicators, symptoms, patient satisfaction, patient expectations, and functional activities. A total score above 85 is considered excellent, 70-84 is good, 60-69 is fair, and below 60 is poor.

  13. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: screening and 12 weeks post-surgery.

    The WOMAC measures knee function in terms of pain, stiffness, and physical function across 25 items. Pain is assessed with five items, stiffness with two items, and physical function with 18 items. Each item is scored from 0 to 4, with higher scores indicating more severe symptoms.

  14. Incidence of adverse events and serious adverse events

    Time frame: Through study completion, an average of 12 weeks

    Throughout the study, any adverse events that occurred were recorded, and the corresponding incidence was calculated.

    Similarly, any serious adverse events that occurred during the study were recorded, and the corresponding incidence was calculated.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Acronym: RA-TKA

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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