Early Radiographic and Clinical Outcomes of Robotic-Arm-Assisted Versus Conventional TKA

NCT05987839 | Completed

• 1 other identifier: robotTKARCT
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: A robotic system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized controlled trial (RCT) study was to determine whether robotic-arm-assisted TKA improves the clinical and radiological outcomes in patients compared to conventional TKA. Methods: One hundred and thirty patients who underwent primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. Five patients were lost to follow-up at 6 weeks after surgery. Therefore, 125 patients (63 in the intervention group and 62 in the control group) remained in the final analysis. The primary outcome was the rate of patients whose mechanical axis of the femur was less than 3° deviated from the mechanical axis of the tibia evaluated by full-length weight-bearing X-rays of the lower limb at 6 weeks postoperatively. Secondary outcomes will include operation times, 6-week postoperative functional outcomes evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-36, adverse events (AEs) and serious adverse events (SAEs). Hypothesis: Robotic-arm-assisted TKA is safe and effective as demonstrated in this trial.

Conditions

Total Knee Arthroplasty; Robotic

Outcome Measures

Primary Outcomes (1)

• rate of alignment inlier

  the rate of patients whose mechanical axis of the femur was less than 3° deviated from the mechanical axis of the tibia evaluated by full-length weight-bearing X-rays of the lower limb at 6 weeks postoperatively

  6 weeks postoperatively

Secondary Outcomes (6)

• operation time

  Intraoperative

• knee society score

  through study completion, an average of 6 weeks after the surgery

• the Western Ontario and McMaster Universities Osteoarthritis Index

  through study completion, an average of 6 weeks after the surgery

• SF-36

  through study completion, an average of 6 weeks after the surgery

• adverse events

  up to 6 weeks after the surgery

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Total knee arthroplasty assisted by knee navigation and positioning system. Specification Model: OP-RKL22

Procedure: robotic system

control group

NO INTERVENTION

Total knee arthroplasty without knee navigation and positioning system

Interventions

robotic system PROCEDURE

Total knee arthroplasty assisted by knee navigation and positioning system

intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years old and younger than 80 years old with knee osteoarthritis undergoing primary and unilateral TKA
• after receiving both an oral and a written explanation of the study protocol, they provided written informed consent that they were willing to complete all of the assessments and potential interventions

You may not qualify if:

• Allergic to metal implants
• Any active systemic and local infection
• Paralysis of muscles around the knee joint or neuropathic arthropathy
• The knee joint has been fused for a long time without pain and deformity
• Patients with severe systemic diseases (severe diabetes, severe osteoporosis, severe muscle loss, etc.), or those who cannot tolerate surgery through systemic evaluation
• Women who are pregnant or breastfeeding, or who expect to give birth during the clinical period
• Patients who are also participating in other clinical studies
• In any case, if the investigator believes that the patient is not suitable for this treatment (the patient's expectations are unrealistic or the patient has significant emotional problems)
• There are other factors that affect the efficacy of observation in this study

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Qianfoshan Hospital: collaborator
• Chifeng Municipal Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Officials

• Zheng Yuhang, MD

  Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group: Total knee arthroplasty assisted by knee navigation and positioning system. Specification Model: OP-RKL22 Control group: Total knee arthroplasty without knee navigation and positioning system The same joint prosthesis was used in both the experimental group and the control group, and was approved by the manufacturer.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-07

Locations

CN (1)