A New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty

May 20, 2015 updated by: Georg Matziolis, University of Jena
Beside the current standard of classical mechanical alignment of total knee replacements, increased interest is being shown in anatomical alignment. However, no surgical technique is capable of controlling the stability of the joint in midflexion. The purpose of the present study was to present and evaluate a new surgical technique, which aims to reduce the need for soft-tissue release and optimize stability in midflexion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients were to undergo surface replacement due to primary osteoarthritis of the knee

Exclusion Criteria:

  • Joints that had undergone open surgery beforehand (e.g. high tibial osteotomy, fracture treatment) were excluded.

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: gap technique (GT)

The patients receive a total knee arthroplasty using the established "gap technique" (gold standard serving as control). The intervention is the implantation of a total knee arthroplasty with this specific technique.

Implantation of TKA using the gap technique is the intervention. Intervention is not a drug but a specific operative technique.
Procedure: Implantation of TKA using the gap technique
Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control.
Experimental: anatomical alignment (AA)

The patients receive a total knee arthroplasty using the new "anatomical alignment technique" (experimental). The intervention is the implantation of a total knee arthroplasty with this specific technique.

Implantation of TKA using anatomical alignment Intervention is not a drug but a specific operative technique.
Procedure: Implantation of TKA using anatomical alignment
Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion
Time Frame: intraoperatively immediately before implantation of definite implants.
The outcome measures are given in mm.
intraoperatively immediately before implantation of definite implants.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
performance of soft tissue release (yes / no) and extend of release if done.
Time Frame: intraoperatively

The surgeon documents postoeperatively if a soft tissue release was done or not and what extend a release had.

The outcome measure is given in numbers (0 ... 4).
intraoperatively

Other Outcome Measures

Outcome Measure
Time Frame
The Knee Society Score
Time Frame: 1 year postoperatively
1 year postoperatively

Collaborators and Investigators

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

Sponsor

University of Jena

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

January 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK_2015_1

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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