Back to resultsA New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Implantation of TKA using the gap technique
Implantation of TKA using anatomical alignment
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total knee arthroplasty, Midflexion instability, Gap technique, Anatomical alignment
Eligibility Criteria
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.
Sites / Locations
- Friedrich-Schiller University Jena, Campus EisenbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
gap technique (GT)
anatomical alignment (AA)
Arm 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.
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.
Outcomes
Primary Outcome Measures
Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion
The outcome measures are given in mm.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02450409
Brief Title
A New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Total knee arthroplasty, Midflexion instability, Gap technique, Anatomical alignment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gap technique (GT)
Arm Type
Active Comparator
Arm 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.
Arm Title
anatomical alignment (AA)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Implantation of TKA using the gap technique
Intervention Description
Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control.
Intervention Type
Procedure
Intervention Name(s)
Implantation of TKA using anatomical alignment
Intervention Description
Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental.
Primary Outcome Measure Information:
Title
Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion
Description
The outcome measures are given in mm.
Time Frame
intraoperatively immediately before implantation of definite implants.
Secondary Outcome Measure Information:
Title
performance of soft tissue release (yes / no) and extend of release if done.
Description
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).
Time Frame
intraoperatively
Other Pre-specified Outcome Measures:
Title
The Knee Society Score
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg Matziolis, Prof. Dr.
Phone
+49 36691 81010
Email
g.matziolis@krankenhaus-eisenberg.de
Facility Information:
Facility Name
Friedrich-Schiller University Jena, Campus Eisenberg
City
Eisenberg
ZIP/Postal Code
07607
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Matziolis, Prof. Dr.
Phone
+49 36691 81010
Email
g.matziolis@krankenhaus-eisenberg.de
12. IPD Sharing Statement
Learn more about this trial
A New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty
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