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

NCT ID: NCT02450409

Last Updated: 2015-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Implantation of TKA using the gap technique

Intervention Type PROCEDURE

Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control.

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.

Group Type EXPERIMENTAL

Implantation of TKA using anatomical alignment

Intervention Type PROCEDURE

Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental.

Interventions

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Implantation of TKA using the gap technique

Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control.

Intervention Type PROCEDURE

Implantation of TKA using anatomical alignment

Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Georg Matziolis

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Friedrich-Schiller University Jena, Campus Eisenberg

Eisenberg, Eisenberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Georg Matziolis, Prof. Dr.

Role: CONTACT

+49 36691 81010

Facility Contacts

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Georg Matziolis, Prof. Dr.

Role: primary

+49 36691 81010

Other Identifiers

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REK_2015_1

Identifier Type: -

Identifier Source: org_study_id

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