Not provided
Not provided
Not provided
Not provided
Not provided
Number of patients willing to participate in the study too low
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as concomitant pain medication are monitored during the first 20 postoperative days and will be compared for the two groups. Various scores are surveyed.
Accuracy of implant positioning and reconstruction of the mechanical leg axis are major requirements for achieving good long-term results in total knee arthroplasty (TKA). A minimally invasive approach might compromise the accuracy due to lacking intraoperative oversight. The purpose of this study is to compare a minimally invasive TKA approach that was performed under control of a navigation system with a standard navigated approach, with respect to patient pain and range of motion.
All patients receive a Columbus knee prosthesis and in both groups an OrthoPilot navigation system is used to control the alignment. Pain intensity using the Visual Analogue Scale (VAS) and concomitant pain medication intake are documented daily during the first 20 days after operation. As long as the patient is hospitalized the Range of Motion will also be documented daily. Knee society score, oxford score, as well as the WOMAC score are monitored pre- and postoperatively.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Navigated total knee arthroplasty with a minimally invasive approach |
|
| 2 | Active Comparator | Navigated total knee arthroplasty with a conventional approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigated TKA with a minimally invasive approach | Procedure | Navigated total knee arthroplasty with a minimally invasive approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake. | daily measurements for 20 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion (ROM) | daily measurements during hospital stay | |
| Knee Society Score (KSS) | preop, postop | |
| Oxford Knee Score (OKS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank Lampe, MD | Schön Kliniken Klinikum Eilbek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frank Lampe, MD | Hamburg | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Navigated TKA with a conventional approach | Procedure | A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed |
|
|
| preop, postop |
| WOMAC-Score | preop, postop |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided