Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. The primary study hypothesis is that in comparing total knee replacement performed with the two different surgical techniques that respect four minimally invasive surgery principles (low-profile instrumentation, "minimally invasive" incision, overall minimal knee surgical intervention), a faster return to function will result when the technique does not incise the tendon.
This study does not include financial compensation for treatments involved.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | - Medial Parapatellar Arthrotomy (MPPA) technique |
|
| 2 | Active Comparator | - Subvastus (SV) technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPPA | Procedure | - Medial Parapatellar Arthrotomy |
| |
| SV |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome: Includes cost-effectiveness of the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups; EQ-5D, SF-12; radiographic assessment using Knee Society Radiographic Assessment. | 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ivan M Tomek, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C061191 | 15-phenyl-beta-methylpentadecanoic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
- Subvastus Technique |
|
| D012216 |
| Rheumatic Diseases |