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| Name | Class |
|---|---|
| Stryker Orthopaedics | INDUSTRY |
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The purpose of this study is to compare two different surgical approaches for total knee replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the knee components. Both will have the same skin incision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mini-midvastus approach | Active Comparator | Mini Midvastus approach with skin incision less than 13 cm long and vastus medialis obliquus dissection not more than 3 cm from the patellar margin was used to perform total knee arthroplasty in 40 patients. |
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| Medial Parapatellar Approach | Active Comparator | Mini Medial Parapatellar approach with skin incision less than 13 cm. The extension into quadriceps tendon did not exceed 3 cm.Mini medial parapatellar approach was used to perform total knee arthroplasty. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty | Procedure | staged bilateral total knee arthroplasty (not more than 7 days between surgeries) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Strength | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. David Heekin, M.D. | Heekin Institute for Orthopedic Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heekin Orthopedic Specialists | Jacksonville | Florida | 32204 | United States |
Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
Forty consecutive patients who underwent staged bilateral TKA (within no more than 7 days)were assessed at 2,6, 12 weeks and 6,12, and24 months postoperatively
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| ID | Title | Description |
|---|---|---|
| FG000 | Mini-midvastus Incision | Total knee arthroplasty : staged bilateral total knee arthroplasty Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini-midvastus approach in one knee and mini-Medial Parapatellar Approachthe in another knee (left or right)within no more than 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
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| ID | Title | Description |
|---|---|---|
| BG000 | Median Parepatellar Approach or Minimidvastus Approach | Total knee arthroplasty : staged bilateral total knee arthroplasty |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knee Society Score | The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain | Posted | Mean | Standard Deviation | score | 2 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midvastus or Medial Parapatellar Approach | Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days. |
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The strength of the study is the standardized surgical protocol performed by a single surgeon and a prospectively randomized consecutive and blinded subjects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. David Heekin MD, FACS | Heekin Institute for Orthopaedic Research | 904-634-0640 | drheekin@heekinortho.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Quadriceps Strength | Not Posted | 2 year |
| 0 |
| 40 |
| 0 |
| 40 |
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| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |