| Primary | Percent Change in Lower Limb Volume | Percent change in lower limb volume as calculated using manual circumference measurements | This is the full analysis set which excludes one subject who lacks data at the 5-7 day visit. | Posted | | Mean | Standard Deviation | percentage of change in lower leg volume | | 5-7 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00014.7± 15.48
- OG00113.3± 12.43
|
|
| |
| Secondary | Percent Change in Lower Limb Volume | Percent change in lower limb volume as calculated using manual circumference measurements | This is the full analysis set which excludes two subjects who lack data at the 12-14 day visit. | Posted | | Mean | Standard Deviation | percentage of change in lower leg volume | | 12-14 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Percent Change in Lower Limb Volume | Percent change in lower limb volume as calculated using manual circumference measurements | This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit. | Posted | | Mean | Standard Deviation | percentage of change in lower leg volume | | 35-49 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Percent Change in Lower Limb Volume | Percent change in lower limb volume as calculated using manual circumference measurements | This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit. | Posted | | Mean | Standard Deviation | percentage of change in lower leg volume | | 77-91 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Percent Change in Lower Limb Circumference | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella | This is the full analysis set which excludes one subject who lacks data at the 5-7 day visit. | Posted | | Mean | Standard Deviation | % change in lower leg circumference | | 5-7 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Percent Change in Lower Limb Circumference | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella | This is the full analysis set which excludes two subjects who lack data at the 12-14 day visit. | Posted | | Mean | Standard Deviation | % change in lower leg circumference | | 12-14 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Percent Change in Lower Limb Circumference | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella | This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit. | Posted | | Mean | Standard Deviation | % change in lower leg circumference | | 35-49 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Percent Change in Lower Limb Circumference | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella | This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit. | Posted | | Mean | Standard Deviation | % change in lower leg circumference | | 77-91 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change in Knee Flexion Angle | Change in knee flexion angle from baseline to Visit 3 | This is the full analysis set which excludes three subjects who lack data at the 5-7 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 5-7 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change in Knee Flexion Angle | Change in knee flexion angle from baseline to Visit 4 | This is the full analysis set which excludes three subjects who lack data at the 12-14 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 12-14 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change in Knee Flexion Angle | Change in knee flexion angle from baseline to Visit 5 | This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 35-49 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change in Knee Flexion Angle | Change in knee flexion angle from baseline to Visit 6 | This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 77-91 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change in Knee Extension Angle | Change in knee extension angle from baseline to Visit 3 | This is the full analysis set which excludes three subjects who lack data at the 5-7 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 5-7 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change in Knee Extension Angle | Change in knee extension angle from baseline to Visit 4 | This is the full analysis set which excludes three subjects who lack data at the 12-14 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 12-14 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change in Knee Extension Angle | Change in knee extension angle from baseline to Visit 5 | This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 35-49 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change in Knee Extension Angle | Change in knee extension angle from baseline to Visit 6 | This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 77-91 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change of Total Range of Motion in Degrees | Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 3 | This is the full analysis set which excludes three subjects who lack data at the 5-7 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 5-7 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change of Total Range of Motion in Degrees | Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 4 | This is the full analysis set which excludes three subjects who lack data at the 12-14 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 12-14 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change of Total Range of Motion in Degrees | Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 5 | This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 35-49 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Change of Total Range of Motion in Degrees | Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 6 | This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit. | Posted | | Mean | Standard Deviation | Degrees | | 77-91 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Incidence of Surgical Site Complications (SSCs) | Incidence of surgical site complications defined as:
- Superficial Surgical Site Infection (SSI)
- Deep SSI
- Full thickness skin dehiscence
- Seroma or hematoma requiring drainage or surgery
- Skin necrosis
- Continued drainage at the time of dressing removal
| This is the full analysis set which excludes three subjects who lack data as of Day 49. | Posted | | Count of Participants | | Participants | | within 49 days of bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Incidence of Surgical Site Complications (SSCs) | Incidence of surgical site complications defined as:
- Superficial Surgical Site Infection (SSI)
- Deep SSI
- Full thickness skin dehiscence
- Seroma or hematoma requiring drainage or surgery
- Skin necrosis
- Continued drainage at the time of dressing removal
| This is the full analysis set which excludes three subjects who lack data as of Day 91. | Posted | | Count of Participants | | Participants | | within 91 days of bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Scar Cosmesis Assessment | Validated tool to assess the quality of postoperative scars in clinical and research settings. Scores range from 4 (best) to 14 (worst). Due to the lack of subjects and study data, only the value recorded at the final study visit was analyzed for each subject. The average score for each study arm was then calculated with the available data. | This is the full analysis set which excludes three subjects who did not complete study | Posted | | Mean | Standard Deviation | units on a scale | | Long Term Follow-up occurring 77-91 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Average Pain in Each Leg in the Last 24 Hours | The average pain in each leg in the last 24 hours, using an NPRS (numerical pain rating scale) of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data. | This is the full analysis set of available data | Posted | | Mean | Standard Deviation | score on a scale | | End of Treatment Visit occurring 12-14 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |
| Secondary | Worst Pain in Each Leg in the Last 24 Hours | The worst pain in each leg in the last 24 hours, using an NPRS of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data. | This is the full analysis set of available data | Posted | | Mean | Standard Deviation | score on a scale | | End of Treatment Visit occurring 12-14 days after bilateral TKA procedure | | | | ID | Title | Description |
|---|
| OG000 | Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision | | OG001 | Standard Silver-containing Dressing | Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision |
| |