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

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Implantation of TKA using the gap technique; Procedure: Implantation of TKA using anatomical alignment

• Registration Number: NCT02450409
• Lead Sponsor: University of Jena

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-20
• Last Update Submitted: 2015-05-20
• Study First Posted: 2015-05-21
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gap technique (GT)	Implantation of TKA using the gap technique	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.
anatomical alignment (AA)	Implantation of TKA using anatomical alignment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
performance of soft tissue release (yes / no) and extend of release if done.	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).

Trial Locations

Locations (1)

Friedrich-Schiller University Jena, Campus Eisenberg; 🇩🇪 Eisenberg, Germany