Comparison of Pinless Navigation and Conventional Method in Total Knee Arthroplasty

January 29, 2020 updated by: Chang Gung Memorial Hospital

Comparison of the Radiographic Outcomes and Total Blood Loss Between Pinless Navigation and Conventional Method in Minimally Invasive Total Knee Arthroplasty

The purpose of this study is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated total knee arthroplasty (TKA) and traditional TKA.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Minimal invasive surgery total knee arthroplasty (MIS-TKA) is an excellent surgical procedure for patients with end-stage knee diseases and can reduce the postoperative complications compared with traditional TKA procedures.

However, MIS-TKA procedures require a long learning curve to avoid malposition of prosthesis. In previous studies have demonstrated that the position of prosthesis and the postoperative mechanical axis are critical factors of outcome. Malposition of prosthesis and deviation more than 3 degrees of mechanical axis will lead to asymmetrical tibia-femoral tracking between prosthesis with the wear of linear, and increase the incidence of prosthesis loosening.

Computer navigation assisted system has been used in TKA procedures for more than one decade and has been proven to improve the accuracy of prosthesis placement and postoperative mechanical alignment. Moreover, navigated TKA avoids the use of intramedullary guide and preserve the medullary cavity of femur, so the risks of bleeding and venous thromboembolism are reduced. However, traditional navigation system requires additional procedure to set reference arrays with pin fixation of femur and tibia. Pin wound complications including bleeding, infection, and iatrogenic fracture were reported. Moreover, traditional navigation system requires conventional TKA approach in which the wound length of the knee will be as long as 15 to 20 cm. Therefore a combination of new navigation system with a MIS technique to perform TKA procedure is required The new pinless navigated system for TKA procedures has been developed, as the navigation tools were fixed in the surgical field without additional pin wounds. This advantage meets the rationale of MIS-TKA to take care of both minimal invasive procedures and accuracy of prosthesis placement. Therefore, the investigators want to investigate the application of this pinless navigation system in MIS-TKA procedures.

Our purpose is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated MIS-TKA and traditional MIS-TKA.

Material and Methods:

The investigators plan to enroll 100 patients who plan to undergo unilateral primary MIS-TKA and will be randomly assigned into two groups. The first group (50 patients) will be treated by pinless-navigation (Stryker, OrthoMap Express Knee Navigation) MIS-TKA, and the second group (50 patients) will undergo traditional MIS-TKA.

The investigators will record the surgical wound length, surgical time cost and calculate daily hemoglobin drainage and total blood loss after TKA procedures for all patients. At 3 months after operation, the whole leg scanography, AP and lat view of knee radiography will be take and the mechanical alignment (MA), anatomic alignment (AA), femoral bowing angle (FBA), and coronal femoral-component angle (CFA), coronal tibia-component angle (CTA) in coronary view and sagittal femoral component angle (SFA), sagittal tibial component angle (STA) in lateral view will be measured. The operating time and surgical wound length in knee full extension will be recorded. All complications including bleedings, wound complications, venous thromboembolism will be recorded.

Study year: one year Expecting Result The investigators anticipate that the position of prosthesis in pinless-navigated MIS-TKA is more accurate or equal to traditional MIS-TKA group. And the total blood loss in pinless-navigated MIS-TKA is less than traditional MIS-TKA group. The complication rate is similar between the two groups

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

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

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with osteoarthritis of the knee secondary to degeneration, inflammatory arthritis, gouty arthritis, posttraumatic arthritis, and undergoing primary unilateral minimally invasive TKA
  2. Age > 50 years and < 90 years
  3. Failure of medical treatment or rehabilitation.
  4. Hemoglobin > 11g/dl,
  5. No use of non-steroid anti-inflammatory agent one week before operation

Exclusion Criteria:

  1. Preoperative Hemoglobin <11 g/dl
  2. History of infection or intraarticular fracture of the affective knee
  3. Renal function deficiency (GFR <30 ml/min/1.73m2)
  4. Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
  5. History of deep vein thrombosis, ischemic heart disease, cardiac arrythmia requiring life-long anti-coagulants, or stroke
  6. Contraindications of tranexamic acid, rivaroxaban, or the excipients
  7. Allergy to tranexamic acid, rivaroxaban, or the excipients
  8. Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
  9. Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
Primary total knee replacement by pinless navigation and minimally invasive technique
Device: Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan)
The varus/valgus, extension/flexion, thickness of distal cut of femur was determined and done by pinless navigation system. After cutting, the instant information of resection level can show on the display screen. If the alignment is satisfying, the anterior/posterior femoral cut, chamfer cut and box resection were done by conventional jig
Active Comparator: Group II
Primary total knee replacement by traditional jig and minimally invasive technique
Procedure: Primary total knee replacement by traditional jig and minimally invasive technique
The femoral alignment was determined by intramedullary guide. The femoral alignment jig was set to 5-7 degree valgus dependent on the preoperative radiograph. A bone plug is impacted into the entry hole of femoral medullary canal before prosthesis placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic outcome: the mechanical alignment (MA)
Time Frame: Three months after operation
The mechanical alignment (MA): an angle between the mechanical axis of the femur and the tibial shaft axis
Three months after operation
Radiographic outcome: anatomic alignment (AA)
Time Frame: Three months after operation
The anatomic alignment (AA): an angle between the axis of the femoral shaft and the tibial shaft axis
Three months after operation
Radiographic outcome: femoral bowing angle (FBA)
Time Frame: Three months after operation
The femoral bowing angle (FBA): the angle between the distal and proximal femoral anatomical axes
Three months after operation
Radiographic outcome: coronal femoral-component angle (CFA)
Time Frame: Three months after operation
Tthe angle between the femoral mechanical axis and the femoral component
Three months after operation
Radiographic outcome: coronal tibia-component angle (CTA)
Time Frame: Three months after operation
The angle between the tibial shaft axis and the tibial component
Three months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Blood Loss
Time Frame: Postoperative Day 3
The total blood loss was calculated according to Nadler et al., which uses maximum postoperative decrease of the Hb level adjusted for weight and height of the patient. Total blood loss consists of amount of blood loss calculated from the maximum Hb loss and amount of blood transfused
Postoperative Day 3
Blood transfusion rate
Time Frame: Three months after operation
Record the event of blood transfusion, and calculate the incidence of transfusion
Three months after operation
Operating Time
Time Frame: After the procedure is done
Time needed for the surgical procedure (skin to skin) is recorded
After the procedure is done
Surgical wound length
Time Frame: After the procedure is done
The surgical wound length at full extension of knee is also recorded
After the procedure is done
Wound complications
Time Frame: Three months after operation
Any wound complications including superficial infection, wound dehiscence, poor healing, etc. are all recorded
Three months after operation
Venous thromboembolism
Time Frame: Postoperative Day 4
perform duplex ultrasound study of both lower limbs in all patients on postoperative day 4
Postoperative Day 4

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8J0311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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