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Comparison of Pinless Navigation and Conventional Method in Total Knee Arthroplasty

NCT04235283 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Osteoarthritis, Knee

Interventions

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

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Jun-Wen Wang, MD · Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235283 on ClinicalTrials.gov