CORD 1K

KEY POINTSManage pain and

inflammationManage scar formation

Improve ROM

CLARIX® FLO for Knee Osteoarthritis ManagementRamon Castellanos, MD - StemCell USA

BACKGROUNDKnee osteoarthritis (OA) is one of the most common painful orthopedic conditions in the US.1

The prevalence of OA increases with age and usually presents in patients between 50 and 85 years old.2, 3 Knee OA can cause severe disability due to the severe pain and interfere with normal activities of daily living (ADL). Current treatments include conservative therapy (medication, physical therapy and weight loss) and minimally invasive injections (intra-articular injection of steroids and hyaluronic acid) however results are variable. Not surprising, the incidence of total knee replacement is rising with approximately 700,000 knee replacement procedures performed annually at a cost of $50,000-70,000.4, 5

CLINICAL HISTORY

A 76 year old male presented with chronic (>1 year) right knee pain and history of diabetes type I, hypertension, hypercholesterolemia, and coronary artery disease. The patient’s pain was constant and severe (VAS score 9 of 10) that got progressively worse 3 months prior after missing a step. The patient had failed previous treatments. He was previously on NSAIDs but discontinued due to gastritis. Physical therapy was conducted without success for 1 month. Steroidal injections were avoided due his diabetes, so the patient received hyaluronic acid injections (x3) but the symptoms did not improve. The patient refused to have surgery due to potential complications.

TREATMENT PROCEDUREAn MRI was performed and examination revealed an area of cartilage loss in the medial compartment in T1 coronal view correlated with an extense area of remodeling in the FS coronal view (Figure 1). The degree of knee osteoarthritis was classified Grade II. Based on the MRI and treatment failures with prior therapies, an intra-articular injection of umbilical cord and amniotic membrane particulate* was warranted. Under asepsis and antisepsis, numbing of the suprapatellar area was performed with 2 cc lidocaine 2% under ultrasound guidance.

The patient also had moderate to severe synovitis so 20 cc of a synovial fluid was drained from the joint which removed the metalloproteinases and would also aid in accurate umbilical cord and amniotic membrane injection. Then 50mg of the particulate product was

reconstituted in 3cc of saline and injected within the joint under live ultrasound guidance.

OUTCOMESix weeks after the injection, the patient’s pain reduced from VAS 9/10 to 7/10, range of motion improved approximately 10 degrees �exion, and patient’s gait was much better. By week 12, patient VAS had decreased to 5/10 and the patient was instructed to start a pool exercise program. Six months after the injection, the patient’s VAS was 2-4/10 depending on

the level of activity. Overall, the patient was extremely satis�ed with the outcome. The patient is now able to exercise in the pool 3 times a week and continue his ADLs without disruption. There were no side effects from the injection.

*Note: CLARIX FLO comprises of the amniotic membrane and umbilical cord particulates. For complete indications, contraindications,

warnings, precautions, and adverse reactions, please reference full package insert. Copyright © 2018 TissueTech Incorporated. All

rights reserved. TissueTech and Clarix are registered trademarks of TissueTech, Inc.

7300 CORPORATE CENTER DR #700 MIAMI, FL 33126

888-709-2140 | WWW.AMNIOXMEDICAL.COM

AX-0415 Rev. 01

1. Lawrence RC, Felson DT, Helmick CG, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008; 58: 26-35.2. Anderson AS and Loeser RF. Why is Osteoarthritis an Age-Related Disease? Best Pract Res Clin Rheumatol. 2010; 24: 15.3. Loeser RF. Age-Related Changes in the Musculoskeletal System and the Development of Osteoarthritis. Clinics in geriatric medicine. 2010; 26: 371-86.4. Maradit Kremers H. Prevalence of Total Hip and Knee Replacement in the United. 2015; 97: 1386-97.5. Nichols CI and Vose JG. Clinical Outcomes and Costs Within 90 Days of Primary or Revision Total Joint Arthroplasty. The Journal of arthroplasty. 2016; 31: 1400-6.e3.

The techniques presented in this case study are for informational purposes

only and contain the opinions of and personal techniques practiced by the treating physician. Each surgeon must

evaluate the appropriateness of the

techniques based on his or her own medical

training and expertise. Many variables including

patient pathology, anatomy, and surgical

techniques may influence procedural outcomes.

While these clinical experiences are valid, the results are not necessarily

typical, indicative or representative of all procedures in which

TissueTech’s products are utilized. TissueTech’s

product line has been used successfully in many patients by physicians of varying specialties during

a variety of medical procedures, and

complications, reactions, and/or adverse events are possible with any medical

intervention. It is not possible to predict or

warrant specific results, nor is it possible to

guarantee patient and/or clinician satisfaction.