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

July 4, 2021 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with knee osteoarthritis who underwent primary TKA

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Brainlab knee 3 navigation system is a kind of imageless computer-assisted navigation system.
Other Names:
  • Brainlab knee 3 navigation system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
lower limb alignment
Time Frame: Within 1 week after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: Immediately after surgery
Time from skin incision to wound closure.
Immediately after surgery
Blood loss
Time Frame: 3 days after surgery
Postoperative drainage volume refers to the drainage volume of the affected knee within 24 hours after the end of surgery, accurate to ml.Gross linear equation was used to calculate the total blood loss and latent blood loss at 3 days after surgery.
3 days after surgery
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 3 months、6 months and 12 months after surgery
The WOMAC is a self administered questionnaire to assess joint function and quality of life for patients with osteoarthritis; it consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). The higher the total score, the worse the patient's pain, stiffness, and functional limitations. The WOMAC is validated for various languages, including Chinese.
3 months、6 months and 12 months after surgery
HSS(Hospital for Special Surgery) score
Time Frame: 6 months and 12 months after surgery
HSS(hospital for special surgery) score HSS(hospital for special surgery) score to evaluate patients postoperative knee joint function. With a total of 100, it has 7 subscales: 1.Pain 0~30; 2. Function 0~22; 3. Mobility 0~18; 4. Flexion deformity 0~10; 6. Stability 0~10; 7. Deduction Item. For each scale, a higher value represents a better outcome. The sum of the subscales is the total score.
6 months and 12 months after surgery
Forgotten Joint Score-12 (FJS-12)
Time Frame: 6 months and 12 months after surgery
The FJS-12 is a PROM for patients who have undergone a TKA; it introduces the concept of a "forgotten" joint as the ideal objective to pursue in prosthetic surgery. It is composed of 12 items, measuring the patient's ability to forget the presence of an artificial joint in their daily life. For each item, there is a five-points Likert scale response. The raw results are converted to a 0-100 points scale. Highest score corresponds to good outcome with the patient not aware about the presence of the prosthesis. In the case of more than 4 answers are missing, the score should not be used .
6 months and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • navigation68480

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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