Degenerative Joint Disease, Osteoarthritis
Conditions
Keywords
Total knee arthroplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
Brief summary
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain, activity level, narcotic consumption, adverse events, and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).
Detailed description
Total knee replacement is a surgical procedure performed to replace the weight-bearing surfaces of the knee joint. The goal of total knee replacement is to improve a patient's mobility by improving the function of the the knee joint. The PEAK PlasmaBlade® uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing total knee replacement.
Interventions
DEVICEPEAK PlasmaBlade 4.0
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 21 and 80 years old 2. Physically healthy, stable weight 3. Requiring unilateral total knee arthroplasty (TKA) 4. Subject exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion 5. Subject has severe knee pain and disability due to degenerative joint disease 6. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure. 7. Subject must be willing and able to comply with all follow-up evaluations 8. Subject must be willing to undergo TKA using the Signature Knee System
Exclusion criteria
1. Age younger than 21 or greater than 80 years old 2. Previous history of infection in the affected joint 3. Peripheral vascular disease 4. Revision procedures 5. BMI \> 35 6. Valgus or varus deformity \> 15 degrees 7. Flexion contracture \> 15 degrees 8. History of diabetes 9. Anticoagulation therapy which cannot be discontinued 10. Cognitive impairment or mental illness 11. Severe cardiopulmonary deficiencies 12. Known coagulopathy 13. Immunocompromised 14. Kidney disease (any type) 15. Unable to follow instructions or complete follow-up 16. Currently taking any medication known to affect healing 17. Currently enrolled in another investigational device or drug trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain | Postoperative (0 to 10 days) | Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days. |
Secondary
| Measure | Time frame |
|---|---|
| Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS) | Intraoperatively and 1-2 weeks postoperatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PlasmaBlade The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision. | 11 |
| Standard of Care (SOC) Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. | 13 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study termination | 11 | 13 |
Baseline characteristics
| Characteristic | PlasmaBlade | Standard of Care (SOC) | Total |
|---|---|---|---|
| Age, Customized 21 to 80 years | 11 participants | 13 participants | 24 participants |
| Gender Female | NA participants | NA participants | 0 participants |
| Gender Male | NA participants | NA participants | 0 participants |
| Region of Enrollment United States | 11 participants | 13 participants | 24 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 11 | 9 / 13 |
| serious Total, serious adverse events | 3 / 11 | 1 / 13 |
Outcome results
Primary
Post-operative Pain
Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.
Time frame: Postoperative (0 to 10 days)
Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.
Secondary
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)
Time frame: Intraoperatively and 1-2 weeks postoperatively
Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.