Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty

December 13, 2016 updated by: Yong In, The Catholic University of Korea

Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial

Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant loosening, and eventual early revision. To avoid these complications, achieving a postoperative alignment within the range of 0°±3° of the mechanical axis is recommended. Manual intramedullary/extramedullary guides are not thought to be capable of consistently achieving axes in this range, and though computer-assisted navigation has shown superior results in comparison with conventional instrumentation, it is also limited by increased surgical times and no clear superiority in improving short-term clinical outcomes. Thus, there has been in a push in the orthopaedic community to create more precise technologies to aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation (PSI), which uses anatomical data obtained primarily from pre-operative axial computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs individualized to the patient's unique anatomy, was created with this goal.

This study aims to compare the clinical results of conventional and patient-specific instruments in total knee arthroplasty.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objective of this work was to compare pain, stiffness, function and accuracy between groups at minimum 2 year postoperatively. The investigators hypothesized that PSI would lead to a neutral mechanical axis on average more frequently than conventional instrumentation.

The study design is a double-blind randomized controlled trial. Randomly, fifty patients planed to undergo total knee arthroplasty using conventional instruments and other fifty patients undergo total knee arthroplasty using patient-specific instruments. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale (preoperative and postoperative 6, 12, 24 months), Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior stress view on X-ray (preoperative and postoperative 6, 12, 24 months).

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.

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

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 19 year old
  • Patients for total knee arthroplasty of both knee
  • over 5 degree in lateral bowing of femur
  • having medicare insurance

Exclusion Criteria:

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Neuropsychiatric patients
  • Hepatic insufficiency
  • Renal insufficiency
  • over 40 of body mass index
  • Chronic opioid use (taking opioids for longer than 3 months)

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
Experimental: patient-specific instruments group
procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.
Procedure: patient-specific instruments
Device: The Signature™ Vanguard
Active Comparator: conventional instruments group
procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.
Procedure: conventional instruments
Device: Vanguard PS(posterior stabilized)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Range of Motion (ROM)
Time Frame: Changes from Baseline Range of Motion at postoperative 1 year
Changes from Baseline Range of Motion at postoperative 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
Time Frame: Changes from Baseline score to score of postoperative 1 year
Changes from Baseline score to score of postoperative 1 year
Changes in Knee Society Score
Time Frame: Changes from Baseline score to score of postoperative 1 year
Changes from Baseline score to score of postoperative 1 year
Changes in Anterior and posterior stress view on X-ray
Time Frame: Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year
Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year

Collaborators and Investigators

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

Sponsor

The Catholic University of Korea

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

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimate)

December 14, 2016

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • patient-specific instruments

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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