Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide

July 28, 2016 updated by: Phonthakorn Panichkul, Thammasat University

Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial

Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 4

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

  • Thailand
      • Pathumthani, Thailand, 12120
        • Thammasat University Hospital.

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

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 60-90
  • Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
  • Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
  • Correction of varus or valgus.
  • Willing to participate and return for follow-up study visits.

Exclusion Criteria:

  • Vascular insufficiency
  • Previous deep vein thrombosis and pulmonary embolism
  • Previous osteotomy
  • Previous patella fracture or surgery
  • Previous healed tibia or femur fractures
  • Previous joint replacement surgery

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard knee cutting guides
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Procedure: Standard knee cutting guides
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Active Comparator: Patient specific cutting guides
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Procedure: Patient specific cutting guides
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films
Time Frame: 3 Months Post-operative
Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation
3 Months Post-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative Bleeding
Time Frame: Intra-operative
Intra-operative
Operative time
Time Frame: During the procedure
During the procedure
Blood volume in suction drain
Time Frame: Post-operative Day 2
Post-operative Day 2
Hemoglobin level
Time Frame: Post-operative day1, 2, 3
Post-operative day1, 2, 3
WOMAC score
Time Frame: 6 weeks
6 weeks
WOMAC score
Time Frame: 3 Months
3 Months
WOMAC score
Time Frame: 6 Months
6 Months
WOMAC score
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
WOMAC Score
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Phonthakorn Panichkul, MD, Thammasat University

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

October 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTu-02 (Other Identifier: Thammasat University)

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.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Standard knee cutting guides

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe