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| Name | Class |
|---|---|
| KCI USA, Inc | INDUSTRY |
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The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk patients prevents wound complications and decreases reoperation rates.
One of the primary causes of un-planned readmission following lower extremity arthroplasty procedures is infection. Continuous wound drainage poses a serious risk for infection and is often initially treated with absorbent dressings and/or oral antibiotics. Comorbidities such as obesity, diabetes and tobacco abuse predisposes to wound complications and therefore infection after these procedures. NPWT has proven to be effective for postoperative drainage and decreases the risk for infection or further reoperation. This prospective randomized trial will involve 160 patients at high risk for infection undergoing revision total knee or hip arthroplasty; 80 patients will be randomly selected to be treated with the NPWT system (Prevena) and randomly selected to be treated with the current standard of care wound dressing (control group). Patients will be enrolled at a single site of the Cleveland Clinic Health System (Main Campus).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevena | Active Comparator | Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). |
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| Control | No Intervention | A standard of care sterile wound dressing will be placed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena | Device | Device will be applied at end of procedure over closed incision. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Wound Complications | Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection. | Within 90 days after surgery |
| Re-operation Rates | Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision | Within 90 days after surgery |
| Readmission Rates | Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision | Within 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Flexion | Mean knee flexion (degrees) at 4 weeks postoperatively | 4 weeks postoperative |
| HOOS and KOOS Scores at 90 Days Postoperatively | Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Higuera-Rueda, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 440195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23539123 | Background | Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3. | |
| 19554385 | Background | Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevena | Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2016 |
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| 90 days postoperative |
| Timed-up-and-go Test | Median Timed-up-and-go test (seconds) | 4 weeks postoperatively |
| Hip Range of Motion (Flexion) | Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively | 4 weeks postoperative |
| VR-12 Questionnaire | Mean VR-12 scores, presented as 2 composite scores physical component summary (PCS) and mental component summary (MCS). Physical Component Score (PCS): Provides greater emphasis on questions about general health, physical functioning and role playing and bodily pain. Mental Component Score (MCS): Provides greater emphasis on questions about role-emotional, vitality/mental health and social functioning. PCS and MCS summary scores are standardized using a z-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10. Higher MCS and PCS scores reflect better overall physical and mental health, respectively. | 90 days postoperatively |
| Hip Range of Motion | Median hip range of motion (extension, in degrees) at 4 weeks postoperatively | 4 weeks postoperative |
| Knee Extension | Median knee extension (degrees) at 4 weeks postoperatively | 4 weeks postoperative |
A standard of care sterile wound dressing will be placed. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevena | Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision. |
| BG001 | Control | A standard of care sterile wound dressing will be placed. |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body mass index | Mean | Full Range | kg/m^2 |
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| Charlson comorbidity index | The Charlson Comorbidity Index contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned with a score of 1,2,3 or 6 depending on the risk of dying associated with this condition. A higher score indicated a higher level of illness. | Count of Participants | Participants |
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| American Society of Anesthesiologists score | American Society of Anesthesiologists score a global score that assesses the physical status of patients before surgery, based on five classes 1 to 5. A higher score indicated a higher level of illness. | Count of Participants | Participants |
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| 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 | Number of Patients With Wound Complications | Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection. | 80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat. 80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat | Posted | Number | participants | Within 90 days after surgery |
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| Primary | Re-operation Rates | Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision | 80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat. 80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat | Posted | Count of Participants | Participants | Within 90 days after surgery |
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| Primary | Readmission Rates | Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision | 80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat. 80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat | Posted | Count of Participants | Participants | Within 90 days after surgery |
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| Secondary | Knee Flexion | Mean knee flexion (degrees) at 4 weeks postoperatively | Posted | Mean | Standard Deviation | degrees | 4 weeks postoperative |
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| Secondary | HOOS and KOOS Scores at 90 Days Postoperatively | Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score. | The number analyzed is different from the overall number because there are separate questionnaires for Hip and Knee, and there were Hips and Knees in both the Prevena and Control groups | Posted | Mean | Standard Deviation | units on a scale | 90 days postoperative |
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| Secondary | HOOS and KOOS Scores at 90 Days Postoperatively | Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score. | The number analyzed is different from the overall number because there are separate questionnaires for Hip and Knee, and there were Hips and Knees in both the Prevena and Control groups | Posted | Median | Inter-Quartile Range | units on a scale | 90 days postoperative |
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| Secondary | Timed-up-and-go Test | Median Timed-up-and-go test (seconds) | Posted | Median | Inter-Quartile Range | seconds | 4 weeks postoperatively |
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| Secondary | Hip Range of Motion (Flexion) | Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively | Posted | Mean | Standard Deviation | degrees | 4 weeks postoperative |
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| Secondary | VR-12 Questionnaire | Mean VR-12 scores, presented as 2 composite scores physical component summary (PCS) and mental component summary (MCS). Physical Component Score (PCS): Provides greater emphasis on questions about general health, physical functioning and role playing and bodily pain. Mental Component Score (MCS): Provides greater emphasis on questions about role-emotional, vitality/mental health and social functioning. PCS and MCS summary scores are standardized using a z-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10. Higher MCS and PCS scores reflect better overall physical and mental health, respectively. | Posted | Mean | Standard Deviation | z-score | 90 days postoperatively |
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| Secondary | Hip Range of Motion | Median hip range of motion (extension, in degrees) at 4 weeks postoperatively | Posted | Median | Inter-Quartile Range | degrees | 4 weeks postoperative |
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| Secondary | Knee Extension | Median knee extension (degrees) at 4 weeks postoperatively | Posted | Median | Inter-Quartile Range | degrees | 4 weeks postoperative |
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90 days
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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 | Prevena | Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision. | 0 | 80 | 26 | 80 | 9 | 80 |
| EG001 | Control | A standard of care sterile wound dressing will be placed. | 0 | 80 | 31 | 80 | 24 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prosthetic Joint Infection | Infections and infestations | Non-systematic Assessment |
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| Dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Venous Thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Readmission | Investigations | Non-systematic Assessment |
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| Reoperation | Investigations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound drainage | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| mild edema (lung) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison K. Klika, MS, Research Manager, Department of Orthopaedic Surgery | Cleveland Clinic | (216) 444-4954 | klikaa@ccf.org |
| Aug 17, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Non-white |
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| 1 |
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| >=2 |
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| >=3 |
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