PFD Management Shares Update PFD/iOI’s FIH Implant

Today, PFD/iOI announced that the final barriers to moving forward with its First-In-Human (FIH) implant of the iKnee have been met. As a result, PFD/iOI is hoping to schedule the FIH implant before the end of Q3, 2023.

The iKnee was created to fill the gap between the costly, inefficient, and non-therapeutic conservative care approaches and the invasive metal joint replacements of a Total Knee Arthroplasty (TKA) that limit care options to deal with knee pain and reduce daily activities and quality of life for patients suffering from osteoarthritis. By creating an arthroscopically implantable device that does not require the wide open joint resection in a patient, with the removal of large sections of bone, and the implantation of heavy hardware made from metals and hard polyethylene prosthetics, the RAD/iKnee allows a patient to be literally back on their feet in less time, at a lower cost, and with less chance of complications as those of TKA’s.

Eric has suffered from debilitating knee pain for more than eight years due to injuries sustained from both sports and heavy use issues and is currently at the point where a TKA would be the traditional next step.

As such Eric meets all the criteria established by the Institutional Review Board (IRB) for the iKnee Comfort Study’s protocols as a candidate for the iKnee implant. The surgery will be performed by PFD/iOI’s Chief Investigator, Dr. Christopher Woodson, who is a board-certified orthopedic surgeon and sports medicine physician, and founder of Beach Orthopedic Specialty Institute.

Dr. Woodson will also be serving as the Principle Investigator for the iKnee Comfort Study’s ongoing trials.

Objective

The objective of the iKnee Comfort Study is to determine the iKnee’s impact on quality of life issues and its ability to allow normal activities of daily living in patients awaiting TKA. The data will be used to improve possible designs to enhance ideal patient comfort.

Study Criteria

The PFD/iOI Comfort Study is designed to allow the company to gather critical data in three major areas:

• The ability of the patient to tolerate the iKnee implant both from a bio-compatibility standpoint and an ortho-comfort level.
• The ability of the iKnee implant to decrease or eliminate the patient’s pain level as it applies to the use of the impacted joint.
• The ability of the iKnee to maintain or expand the patient’s quality of life as it pertains to daily activity, leisure and recreational movement, and/or active sports engagement.

In addition, the study will be looking at additional areas of impact including the iKnee’s ability to provide:

• better patient outcomes
• faster recovery
• lower cost
• lower risk

Candidate Selection

Candidate selection for the study will be done by PFD/iOI’s IRB which is being sponsored and managed by Advarra, who is a global leader in supplying IRB allowances, institutional bio-safety committee and research compliance services to clinical trial sponsors, CROs, hospital systems, academic medical centers, and investigators. Candidates for the trial must meet the following criteria:
Debilitating knee pain and disability after failed conservative treatment.
Be a candidate for TKA but show a reasonable expectation of temporary comfort with an iKnee implant.

• Have a BMI of 30 or less.
• Have had continual and chronic adverse issues with their knee joint.
• Have a pre-operative Visual Analogue Pain Scale (VAS) score of ≥4.
• Be referred to the study by their Primary Care Physician (PCP) or by a qualified referring orthopedic specialist.
• Have no disqualifying health conditions or risks.

Once prospective candidates have submitted their applications, they are vetted by the PFD/iOI IRB for potential inclusion into the study. The application screening process consists of a series of steps to ensure that the candidate will be a viable cohort for the program and that there is an anticipated benefit to the patient’s knee condition and quality of life as a result of participation. The application review consists of an initial patient consult with a PFD/iOI-certified physician that includes:

• Initial patient background history (HPI, PMH, FH, ROS).
• Physical examination including a VAS and joint mobility assessment.
• Initial consult on study overview, implantation procedure, and benefit/risk assessment.
• Correlation of assimilated data and ancillary lab/imaging leading to predicted beneficial iKnee outcome.

Based on this evaluation, a request for medical records, copies of the latest radiological films, which can include X-rays, CT and MRI scans, and any needed lab work is made. Once procured, an in-depth review of the applicant’s records, films, and labs is made by the qualified PFD/iOI surgeon along with the IRB.

Candidate Acceptance and Implant

If at this point the applicant is deemed to be a viable cohort, a second consult is scheduled during which the study protocols and the implant procedure are once again thoroughly reviewed. If the applicant decides to move forward, a detailed Informed Consent document is signed along with any related additional release and medical information paperwork. Once processed the patient is given a case ID and a surgery date is scheduled.

The iKnee implant procedure itself is done on an outpatient basis at a qualified PFD/iOI-authorized surgery center. The surgery takes an hour to perform and barring any complications, the patient is released and able to bear weight on the implanted knee that day.

Patient follow-up for the study is performed at 10 days, week six, week 12, week 24, and at one year plus annually thereafter, in order to assess the patient’s response to the iKnee care. In these post-operative follow-ups, the patient is assessed for:

• Comfort and level of pain
• Joint mobility
• Infection or inflammation
• Evaluation of post-op imaging
• Quality of life changes.

Post-Operative Follow-Up

The data is carefully recorded at each step and becomes part of the ongoing evaluation to ascertain several criteria including:

• iKnee design for possible improvements.
• Material integrity and bio-compatibility.
• The ability of the implant to lower or eliminate joint pain.

If, as expected, the initial FIH procedure is successful as defined by the study’s criteria of comfort, reduced pain, and bio-acceptance, enrollment of the next group of cohorts will begin immediately and evaluation and approval of other surgical centers across the US will proceed.

PFD/iOI is very proud that it has been able to bring this much-needed vision for a cure to the point of FIH use and is excited to see the results of its efforts in not only moving the product technology forward but in restoring hope and vitality to its first recipient.