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

U

University of Jena

Status

Unknown

Conditions

Osteoarthritis, Knee

Treatments

Procedure: Implantation of TKA using the gap technique
Procedure: Implantation of TKA using anatomical alignment

Study type

Interventional

Funder types

Other

Identifiers

NCT02450409
REK_2015_1

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

56 participants in 2 patient groups

gap technique (GT)
Active Comparator group
Description:
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.
Treatment:
Procedure: Implantation of TKA using the gap technique
anatomical alignment (AA)
Experimental group
Description:
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.
Treatment:
Procedure: Implantation of TKA using anatomical alignment

Trial contacts and locations

1

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Central trial contact

Georg Matziolis, Prof. Dr.

Data sourced from clinicaltrials.gov

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