Termination due to acquisition of PEAK Surgical by Medtronic

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).

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.

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

Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.