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

NCT ID: NCT04960345

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-31

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.

Detailed Description

According to the inclusion criteria, patients receiving primary total knee arthroplasty were recruited and divided into two groups after doctor-patient joint decision: the traditional group underwent prosthesis placement using traditional intramedullary positioning method;The navigation group performed surgery using the Brainlab Knee 3 navigation system.Informed consent was signed after grouping. All patients were operated by the same knee prosthesis system. Both groups underwent the same procedures such as the installation of the soft tissue adjustment, prosthesis placement, wound closure and so on.All patients were given the same perioperative treatment, such as hemostasis, anti-infection and analgesia, and routine postoperative rehabilitation exercises. The full length anteroposterior and lateral radiographs of both lower extremities in weight-bearing position were taken preoperatively and one week postoperatively.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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The traditional group

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

No interventions assigned to this group

The navigation group

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

Brainlab Knee 3

Intervention Type: DEVICE

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

Interventions

Brainlab Knee 3

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

Intervention Type: DEVICE

Other Intervention Names

Brainlab knee 3 navigation system

Eligibility Criteria

Inclusion Criteria

1. Patients with knee osteoarthritis who underwent primary TKA;

2. Informed consent has been signed and medical records are complete;

3. No severe varus or valgus deformity of the knee (< 20°).

Exclusion Criteria

1. Patients undergoing revision knee replacement;

2. patients with rheumatoid arthritis and secondary knee osteoarthritis;

3. Patients with severe valgus deformity(≥ 20°);

4. 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hua Tian

Role: CONTACT

tianhua@bjmu.edu.cn

13511065187

Other Identifiers

navigation68480

Identifier Type: -

Identifier Source: org_study_id