A Randomized Controlled Trial of the Sagittal Alignment Difference Between Mako Robotic TKA and Manual TKA

NCT06527911 | Not Yet Recruiting

• 1 other identifier: 2023KY023-KS001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

As China transitions into an aging society, the proportion of the elderly population is escalating, with a corresponding rise in the number of patients with knee joint diseases. Total knee arthroplasty stands as an effective treatment for joint disorders, effectively reducing knee pain, restoring functionality, and enhancing quality of life. The objectives of total knee arthroplasty are to relieve pain, restore function, and ensure a long-lasting implant. In recent years, technological advancements have integrated robotic assistance into total knee arthroplasty (TKA), aiding surgeons in planning and executing more accurate surgical plans, significantly enhancing precision and post-operative outcomes. However, the Mako mechanical axis alignment demonstrated during the Mako robot-assisted TKA procedure does not correspond to the actual straightening of the lower limb, and discrepancies may exist in sagittal alignment between Mako-assisted and manual TKA procedures, necessitating adjustments by surgeons based on their experience. Consequently, there is an urgent need to develop a mathematical formula that quantifies these differences to guide intraoperative alignment. Additionally, the Mako-assisted TKA femoral prosthesis exhibits a head-lowering issue, and differences exist in the posterior slope angle of the tibial plateau compared to manual TKA, necessitating further comparative analysis to draw definitive conclusions. This study will be carried out at the People's Liberation Army General Hospital, with an anticipated enrollment of approximately 100 participants.

Conditions

Arthroplasty; Replacement; Knee; Osteoarthritis; Robotic Surgical Procedures

Outcome Measures

Primary Outcomes (4)

• The extension angle displayed by the Mako robot at the conclusion of the Mako-assisted Total Knee Arthroplasty (TKA) procedure

  From admission to discharge, up to 1 week

• Sagittal plane femoral anterior arch angle

  From admission to discharge, up to 1 week

• Preoperative and postoperative coronal hip-knee-ankle (HKA) angles, lateral distal femoral angle (LDFA), and medial proximal tibial angle (MPTA) in Mako robot-assisted TKA and manual TKA

  From admission to discharge, up to 1 week

• Preoperative and postoperative sagittal measurement of the tibial plateau posterior slope angle; postoperative femoral prosthesis head-down angle

  From admission to discharge, up to 1 week

Secondary Outcomes (1)

• Basic demographic profile of the patient

  From admission to discharge, up to 1 week

Study Arms (2)

Mako robot assisted TKA

Patients with osteoarthritis (OA) who underwent Mako robot-assisted TKA at the Chinese PLA General Hospital between September 2024 and September 2026.

Manual TKA

Patients with OA who underwent manual TKA at the Chinese PLA General Hospital between September 2024 and September 2026.

Eligibility Criteria

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

Study Population

OA patients who underwent Mako robot assisted TKA and manual TKA (Stryker Triathlon prosthesis) in the Department of joint surgery of the PLA General Hospital from September 2024 to September 2026 were screened.

You may qualify if:

• The age ranged from 18 to 80 years old;
• OA patients who underwent Mako robot assisted TKA and manual TKA (Stryker Triathlon prosthesis) in the Department of joint surgery of the PLA General Hospital from September 2024 to September 2026;
• All patients were required to take full-length anteroposterior and lateral radiographs of lower limbs, anteroposterior and lateral radiographs of both knees, and lower limb sagittal EOS before and after surgery;
• Physical and mental health, able to participate in and cooperate with the test;
• Patients are willing to participate in the study and sign written informed consent.

You may not qualify if:

• People unable to conduct EOS inspection;
• Combined with knee meniscus injury, anterior cruciate ligament injury and other diseases that may affect the sagittal force line of the knee joint
• Combined with other diseases that may affect the study
• Patients refused to use their imaging data and knee score for this study.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wei Chai, doctorate

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Wei Chai, doctorate

CONTACT

13601372998; chaiwei301@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CN (1)