Prosthesis-related Infections, Wound Complications, Joint Diseases, Musculoskeletal Diseases
Conditions
Keywords
Revision total knee arthroplasty, Revision total hip arthroplasty, Negative pressure wound therapy system (NPWT), Drainage
Brief summary
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.
Detailed description
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).
Interventions
DEVICEPrevena
Device will be applied at end of procedure over closed incision.
Sponsors
KCI USA, Inc
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled revision Total Hip or Knee Arthroplasty Procedure * Presence of one of the following: body mass index (BMI) greater than 35, use of blood thinners other than acetylsalicylic acid (ASA) after surgery, peripheral vascular disease, depression, diabetes mellitus, current tobacco use, history of prior infection, current use of immunomodulators or steroids, current history of cancer or hematological malignancy, rheumatoid arthritis, renal failure or dialysis, malnutrition, liver disease, transplant status, or HIV.
Exclusion criteria
* Patient lives \>100 miles from hospital * Patient is \< 18 years old * Silver allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Wound Complications | Within 90 days after surgery | Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection. |
| Re-operation Rates | Within 90 days after surgery | Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision |
| Readmission Rates | Within 90 days after surgery | Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hip Range of Motion (Flexion) | 4 weeks postoperative | Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively |
| VR-12 Questionnaire | 90 days postoperatively | 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. |
| Knee Flexion | 4 weeks postoperative | Mean knee flexion (degrees) at 4 weeks postoperatively |
| Knee Extension | 4 weeks postoperative | Median knee extension (degrees) at 4 weeks postoperatively |
| Hip Range of Motion | 4 weeks postoperative | Median hip range of motion (extension, in degrees) at 4 weeks postoperatively |
| HOOS and KOOS Scores at 90 Days Postoperatively | 90 days postoperative | 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. |
| Timed-up-and-go Test | 4 weeks postoperatively | Median Timed-up-and-go test (seconds) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| Control A standard of care sterile wound dressing will be placed. | 80 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Total | Prevena |
|---|---|---|---|
| Age, Continuous | 65 years | 65 years | 65 years |
| American Society of Anesthesiologists score =<2 | 10 Participants | 24 Participants | 14 Participants |
| American Society of Anesthesiologists score >=3 | 70 Participants | 136 Participants | 66 Participants |
| Body mass index | 33.4 kg/m^2 | 32.7 kg/m^2 | 31.9 kg/m^2 |
| Charlson comorbidity index 0 | 24 Participants | 56 Participants | 32 Participants |
| Charlson comorbidity index 1 | 21 Participants | 40 Participants | 19 Participants |
| Charlson comorbidity index >=2 | 35 Participants | 64 Participants | 29 Participants |
| Race/Ethnicity, Customized Non-white | 14 Participants | 29 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 66 Participants | 131 Participants | 65 Participants |
| Sex: Female, Male Female | 35 Participants | 75 Participants | 40 Participants |
| Sex: Female, Male Male | 45 Participants | 85 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 9 / 80 | 24 / 80 |
| serious Total, serious adverse events | 26 / 80 | 31 / 80 |
Outcome results
Primary
Number of Patients With Wound Complications
Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.
Time frame: Within 90 days after surgery
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevena | Number of Patients With Wound Complications | 9 participants |
| Control | Number of Patients With Wound Complications | 22 participants |
Primary
Readmission Rates
Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision
Time frame: Within 90 days after surgery
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevena | Readmission Rates | 16 Participants |
| Control | Readmission Rates | 16 Participants |
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
Time frame: Within 90 days after surgery
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevena | Re-operation Rates | 5 Participants |
| Control | Re-operation Rates | 11 Participants |
Secondary
Hip Range of Motion
Median hip range of motion (extension, in degrees) at 4 weeks postoperatively
Time frame: 4 weeks postoperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prevena | Hip Range of Motion | 5 degrees |
| Control | Hip Range of Motion | 0 degrees |
Secondary
Hip Range of Motion (Flexion)
Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively
Time frame: 4 weeks postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prevena | Hip Range of Motion (Flexion) | 73.6 degrees | Standard Deviation 22.9 |
| Control | Hip Range of Motion (Flexion) | 75.3 degrees | Standard Deviation 25 |
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.
Time frame: 90 days postoperative
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS sports/rec | 18.8 units on a scale |
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS QOL | 43.8 units on a scale |
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS sports/rec | 0 units on a scale |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS sports/rec | 21.9 units on a scale |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS QOL | 34.4 units on a scale |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS sports/rec | 10 units on a scale |
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.
Time frame: 90 days postoperative
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS QOL | 42.7 units on a scale | Standard Deviation 21.3 |
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS symptoms | 58.9 units on a scale | Standard Deviation 18.1 |
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS ADL | 64.1 units on a scale | Standard Deviation 23.9 |
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS Pain | 72.4 units on a scale | Standard Deviation 23.7 |
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS Symptoms | 71.3 units on a scale | Standard Deviation 17.4 |
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS ADL | 60.5 units on a scale | Standard Deviation 24.7 |
| Prevena | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS pain | 57.1 units on a scale | Standard Deviation 24.9 |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS symptoms | 55.9 units on a scale | Standard Deviation 20.2 |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS QOL | 37.9 units on a scale | Standard Deviation 26.6 |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS Symptoms | 70.2 units on a scale | Standard Deviation 23.5 |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS pain | 55.8 units on a scale | Standard Deviation 25.5 |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS Pain | 70.3 units on a scale | Standard Deviation 26.5 |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | KOOS ADL | 54.3 units on a scale | Standard Deviation 22.9 |
| Control | HOOS and KOOS Scores at 90 Days Postoperatively | HOOS ADL | 66.4 units on a scale | Standard Deviation 25.3 |
Secondary
Knee Extension
Median knee extension (degrees) at 4 weeks postoperatively
Time frame: 4 weeks postoperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prevena | Knee Extension | 5 degrees |
| Control | Knee Extension | 5 degrees |
Secondary
Knee Flexion
Mean knee flexion (degrees) at 4 weeks postoperatively
Time frame: 4 weeks postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prevena | Knee Flexion | 89.7 degrees | Standard Deviation 21.6 |
| Control | Knee Flexion | 88.9 degrees | Standard Deviation 23.3 |
Secondary
Timed-up-and-go Test
Median Timed-up-and-go test (seconds)
Time frame: 4 weeks postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prevena | Timed-up-and-go Test | 25 seconds |
| Control | Timed-up-and-go Test | 24.2 seconds |
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.
Time frame: 90 days postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prevena | VR-12 Questionnaire | PCS | 33.3 z-score | Standard Deviation 9.6 |
| Prevena | VR-12 Questionnaire | MCS | 50.2 z-score | Standard Deviation 12.3 |
| Control | VR-12 Questionnaire | PCS | 31.5 z-score | Standard Deviation 10.3 |
| Control | VR-12 Questionnaire | MCS | 46.6 z-score | Standard Deviation 14.1 |