Comparison Between Brainlab Knee 3 Computer-assisted Navigation Systems and Conventional Instruments in TKA: a Prospective Cohort Study.

NCT04960345 | Unknown DMC

• 1 other identifier: navigation68480
• Study Type: observational
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a a prospective cohort study. According to the inclusion criteria, volunteers were recruited from patients undergoing total knee arthroplasty. The patients are devided into two groups: the conventional TKA,the computer-assisted surgery(CAS) using Brainlab Knee 3 system.The differences of postoperative alignment,operative time,blood loss will be studied between the two groups.Clinical and functional evaluation using the scoring system of HSS(Hospital for Special Surgery) score, Western Ontario and McMaster University osteoarthritis index (WOMAC), Forgotten joint score(FJS-12) will be compared between the 2 groups,after surgery, and at the follow-up of 3 months、6 months and 12 months.

Conditions

Total Knee Arthroplasty

Keywords

Total knee arthroplasty; Lower limb alignment; Navigation; Functional outcomes

Outcome Measures

Primary Outcomes (1)

• lower limb alignment

  knee-ankle angle (HKA) and components placement using coronal femoral-component angle (CFA) and coronal tibia- component angle (CTA)、sagittal femoral-component angle (SFA) and sagittal tibia-component angle（STA）.

  Within 1 week after surgery

Secondary Outcomes (5)

• Operation time

  Immediately after surgery

• Blood loss

  3 days after surgery

• the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  3 months、6 months and 12 months after surgery

• HSS(Hospital for Special Surgery) score

  6 months and 12 months after surgery

• Forgotten Joint Score-12 (FJS-12)

  6 months and 12 months after surgery

Study Arms (2)

The traditional group

The traditional group underwent prosthesis placement using traditional intramedullary positioning method.

The navigation group

The navigation group performed surgery using the Brainlab Knee 3 navigation system.Informed consent was signed after grouping.

Device: Brainlab Knee 3

Interventions

Brainlab Knee 3 DEVICE

Brainlab knee 3 navigation system is a kind of imageless computer-assisted navigation system.

Also known as: Brainlab knee 3 navigation system

The navigation group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with knee osteoarthritis who underwent primary TKA

You may qualify if:

• Patients with knee osteoarthritis who underwent primary TKA;
• Informed consent has been signed and medical records are complete;
• No severe varus or valgus deformity of the knee (\< 20°).

You may not qualify if:

• Patients undergoing revision knee replacement;
• patients with rheumatoid arthritis and secondary knee osteoarthritis;
• Patients with severe valgus deformity(≥ 20°);
• Taking anticoagulant drugs for a long time in the past, or suffering from the following diseases: Renal insufficiency, liver insufficiency, severe heart disease (or coronary stent implantation within the last 12 months), severe respiratory disease, history of deep vein thrombosis in the lower extremities or a high risk of thrombosis (hereditary/acquired thrombosis), coagulation dysfunction, stroke, and malignancy

Sponsors & Collaborators

• Peking University Third Hospital: lead

Central Study Contacts

Hua Tian

CONTACT

13511065187; tianhua@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 13, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: July 13, 2021

Record last verified: 2021-07