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Medical device knee implant
- 1. Medical device Knee Implant Presentedby Valeria A. Aguirre Fellow at Academy of Applied Pharmaceutical Sciences, AAPS
- 2. Introduction Description of thedevice Indications Risks and complications Risks/ Benefits Cost Clinical Trials
- 3. Introduction: ▪ Although replacingthe total knee joint is the most common procedure, some people can benefit from just a partial knee replacement. ▪ Implants are made of metal alloys, ceramic material, or strong plastic parts, and can be joined to bones by acrylic cement. ▪ Several manufacturers make knee implants and there are more than 150 knee replacement designs on the market today.
- 4. Normal Knee anatomyand function:
- 5. Knee implant components The lowerends of the femur The top surface of the tibia The back surface of the patella.
- 7. Implant materials: ▪ Metalparts: titanium or cobalt-chromium based alloys. ▪ Plastic part: ultra high molecular weight polyethylene ▪ Cemented fixation: polymethylmethacrylate ▪ hybrid fixation: femoral component: without cement tibial and patellar components: with cement.
- 8. Indications for KneeReplacement Surgery: Knee pain that hinders walking, climbing stairs, or getting in and out of a chair Knee pain that interferes with sleep or does not subside with rest Inability to cope with side effects of pain relief medication Knee swelling that does not respond to treatment and that limits bending or straightening the knee Significant bowing in or out of the knee Osteoarthritis severe cases
- 9. Risk and complicationsof replacement surgery Complications from Anesthesia: Most common side effects: ▪ vomiting ▪ dizziness ▪ shivering ▪ sore throat ▪ aches and pains ▪ discomfort ▪ drowsiness Negative reactions: ▪ dental trauma ▪ croup (swelling of the windpipe) ▪ allergic reactions to latex ▪ wheezing ▪ vocal cord injury ▪ stomach problems ▪ injuries to arteries, veins, or nerves
- 10. Blood Clots: • deepvein thrombosis (DVT) and pulmonary embolism (PE) • typically occur within two weeks of surgery • they can also take place within a few hours or even in the operating room • smoking or obesity, increase the risk.
- 11. Infection: • The numberof people who get an infection after a knee replacement is very low • People with rheumatoid arthritis or diabetes have a greater risk of infection in the weeks following a procedure because of their altered immune system • Infection in another part of the body at the time of a knee operation, could lead to an infection in the knee months or even years later
- 12. Complications from aTransfusion •hives •fever •chills •shortness of breath •red urine Signs and symptoms of an adverse transfusion reaction usually occur within 24 hours
- 13. Allergy to MetalComponents Wound and Bleeding Complications Artery Injuries Nerve or Neurovascular Damage Knee Stiffness and Loss of Motion in the Knee
- 14. Prosthesis Problems andImplant Failure • Improper placement or a malfunction of the implant: -new knee might not bend properly -the prosthesis might loosen from the bone over the long- term -Other parts in the artificial knee could break down • These failures are extremely rare • Revision surgery is usually required to fix the problem when this does happen
- 15. Mortality: • The riskof death from knee replacement is very low, but it does occur • A 2010 study published in the Journal of Bone and Joint Surgery estimated the risk of mortality to be 0.1 percent • The risk is highest during the first month after surgery
- 16. Risks/ Benefits Benefits: ▪Pain relief ▪Improvejoint function Risks: ▪The same dangers as other major surgeries ▪The new joint may not work as well as hoped ▪Implant becomes loose or dislocates
- 17. Price Estimates ▪Including roomfee, nurse fee, food, pre- op tests, medical supplies, medication, operating room fee, x-rays, and consulation Country Price (USD) United States $45,000-$60,000 Singapore $18,000-$22,500 Thailand $12,000-$14,200 Taiwan $9,000 – $10,100 India $7,000 – $11,200
- 18. Cost of aknee replacement in selected countries as of 2015 (in U.S. dollars)
- 19. Clinical Trial: Phase-4Study ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the- Shelf Replacement
- 20. Sponsor: ConforMIS, Inc. http://www.conformis.com/ ClinicalTrials.govIdentifier: NCT02494544
- 21. Traditional knee replacements comein standardized sizes which require shaving the femur bone to fit the implant iTotal knee replacement implants are custom made to fit each individual patient
- 22. Purpose: • Patients willbe randomized to either ConforMIS iTotal Knee Replacement or Off the Shelf knee replacement • The patient will conduct functional testing and answer questionnaires • The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement
- 23. Study Type:Interventional Study Design: Allocation:Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Basic Science
- 24. Estimated Enrollment: 800 StudyStart Date: July 2015 Estimated Study Completion Date: August 2025 Estimated Primary Completion Date: August 2016 (primary outcome measure)
- 25. Primary Outcome Measures: •Functional Testing after 1 year • Comparing the functional testing differences between iTotal and off the shelf
- 26. Secondary Outcome Measures: •Patientreported outcome using questionnaires •Incidents of major procedure-related and device related complications •Post-operative limb alignment based using x-ray
- 27. Inclusion Criteria: • Clinicalcondition for the use of iTotal CR • Osteoarthritis • > 18 years of age
- 28. Exclusion Criteria: • Subjectwill require a simultaneous bilateral procedure • Other lower extremity surgery within 1 year • Severe (> 15º) fixed valgus or varus deformity • Severe (> 15º) extension deficit • Severe instability due to advanced loss of osteochondral structure • Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified • Insufficient bone stock on the femoral or tibial surfaces • Contralateral knee replacement surgery within the past 6 months • BMI > 40
- 29. • Active malignancy •Poorly controlled diabetes • Immunocompromised • Other physical disability affecting the hips, spine, or contralateral knee that limits function • Disabling chronic pain with narcotic dependence • Compromised PCL or collateral ligament • Prior history of failed implant surgery • Prior history of failed high tibial osteotomy (HTO) • Participation in another clinical study which would confound results • Inability to complete the protocol
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