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

Osteoarthritis, Knee Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450409
• Other study ID #: REK_2015_1
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2015
• Last updated: May 20, 2015
• Start date: January 2014

Study information

• Verified date: May 2015
• Source: University of Jena
• Contact: Georg Matziolis, Prof. Dr.
• Phone: +49 36691 81010
• Email: g.matziolis[@]krankenhaus-eisenberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Implantation of TKA using the gap technique
Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control.
• Implantation of TKA using anatomical alignment
Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental.

Locations

Country	Name	City	State
Germany	Friedrich-Schiller University Jena, Campus Eisenberg	Eisenberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Knee Society Score		1 year postoperatively	No
Primary	Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion	The outcome measures are given in mm.	intraoperatively immediately before implantation of definite implants.	No
Secondary	performance of soft tissue release (yes / no) and extend of release if done.	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	No