MedTrace Logo

Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)

NCT03659318 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 674

Last updated 2019-07-23

No results posted yet for this study

Summary

Robotic-assisted total knee arthroplasty (TKA) was introduced to attempt to enhance the precision of bone preparation, component alignment and ultimately improve clinical results and survivorship of TKA. Although several published data suggest that bone preparation, and knee component alignment were improved by using robotic assistance, there is no high-quality evidence from randomized trials at long-term of which investigators are aware evaluating whether the improved bone preparation and knee component alignment improved clinical function or longevity of the TKA.

Conditions

Interventions

PROCEDURE

Robotic-assisted TKA

Total knee arthroplasty is carried out with help of robotic surgery system, using a Robodoc system. CT-based preoperative planning using ORTHODOC (Integrated Surgical Technology Corp) performed in the first step before the day of surgery, and the robotic-assisted surgery using the ROBODOC surgical assistance in the second step. The bone markers are registered to the computer, and the computer arm does all the cutting and preparation of bones. This is in contrast to conventional jigs and cutting blocks. Actual implantation of the implants is done by a surgeon. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.

PROCEDURE

Conventional TKA

Total knee arthroplasty is carried out with classical, conventional, manual method. A surgeon measures the angle, length of the cuts with bone landmarks and specialized surgical instruments. After all the cuts actual implantation is done. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.

Sponsors & Collaborators

  • Ewha Womans University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2008-02-29
Completion
2018-07-31

More Related Trials

Entities

Diseases

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 NCT03659318 on ClinicalTrials.gov