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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gap technique (GT) | Active Comparator | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of TKA using the gap technique | Procedure | Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Knee Society Score | 1 year postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georg Matziolis, Prof. Dr. | Contact | +49 36691 81010 | g.matziolis@krankenhaus-eisenberg.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich-Schiller University Jena, Campus Eisenberg | Recruiting | Eisenberg | Eisenberg | 07607 | Germany |
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| Implantation of TKA using anatomical alignment | Procedure | Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental. |
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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