Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05391152
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 37

Study Details

Study Description

Brief Summary

This is a multicenter, prospective, and case-control study. Five joint centers and 100 participants will be included. The study group used robotic-assisted modified kinematic alignment total knee replacement, and the control study used traditional alignment manual total knee replacement. The knee society score (KSS), Hip-knee-ankle(HKA) angle, mechanical lateral distal femoral angle(mLDFA), mechanical medial proximal tibial angle(mMPTA), sagittal femoral component angle(SFCA), range of motion(ROM), WOMAC score, SF-36, Visual Analogue Scale(VAS score), surgical time, blood loss, and complications are evaluated and compared.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Device: robotic assisted total knee replacement; Device: traditional total knee replacement	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison Between Robotic-Arm Assisted Modified Kinematic Alignment Total Knee Replacement And Traditional Manual Alignment Total Knee Replacement：A Prospective Multicenter, Double-Blind Study
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: robotic-arm assisted modified kinematic alignment total knee replacement The patients in this group receive robotic-arm assisted total knee replacement. And these patients achieve modified kinematic alignment.	Device: robotic assisted total knee replacement; the study group used robotic-arm assisted total knee replacement.
Active Comparator: traditional manual total knee replacement The patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment.	Device: traditional total knee replacement; the control group used traditional total knee replacement

Outcome Measures

Primary Outcome Measures

1. KSS score [3 months]

   Keen Society Score

Secondary Outcome Measures

1. HKA angle [3 months]

   hip-knee-ankle angle

2. mLDFA [3 months]

   mechanical lateral distal femoral angle

3. mMPTA [3 months]

   mechanical medial proximal tibial angle

4. SFCA [3 months]

   sagittal femoral component angle

5. knee ROM [3 months]

   knee range of motion

6. blood loss [intraoperative]

   the intraoperative blood loss

7. surgical duration [intraoperative]

   the duration of the operation

8. complication [3 months]

   complications after the surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age between 18 years and 85 years

• primary total knee replacement

Exclusion Criteria:

• obvious bone defect

• infection

• BMI>>35kg/m2

• severe osteoporosis

• mental disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05391152
• Other Study ID Numbers: 202203
• First Posted: May 25, 2022
• Last Update Posted: May 25, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: robotic-arm assisted; total knee replacement; kinematic alignment
• Additional relevant MeSH terms: Osteoarthritis, Knee

Study Results

No Results Posted as of May 25, 2022