Total Osteo-Cartilage Replacement for the Treatment of Osteoarthritis of Knee

Detailed Description Procedure for the TOCR: A cruciate knee replacement requires less bone and soft tissue resection. A more normal transmission of the weight-bearing stresses is possible compared to other knee Measures of Treatment Compliance: None. Study Procedures and Guidelines: replacements. Preserving both cruciate ligaments mandates the correct tension on all ligaments. Bi-cruciate retaining (BCR) TKA is considered to show improved clinical function and kinematics.The standard technique of the Bi-cruciate retaining (BCR) TKA is described. The importance of retaining both the cruciate ligaments cannot be over emphasized. In TOCR both the cruciate ligaments retained are native. The Cruciate ligaments, particularly the Anterior Cruciate Ligament (ACL), are vital for knee proprioception, acting as specialized sensors that inform the brain about knee position, movement, and load. They contain mechanoreceptors that initiate reflex muscle contractions to stabilize the joint. In standard TKR both the cruciate are removed making the stability on the implants. Figure I gives the standard cuts of the Femur and Tibia using the routine instrumentation of the Bi-cruciate retaining (BCR) TKA. During regular TKR, the bone segments removed are discarded, and this will follow the same procedure as TOCR. TOCR uses standard instrumentation of the bi-cruciate retaining TKR. All the cuts and procedures are similar to the TKR. Instead of metallic and polyethylene implants, a custom-matched Allograft of the femoral cartilage and Tibial plateau will be performed. The Allograft will be fixed with 2 Acutrak 2, 7.5mm X 120mm long, in the femur and tibia. The menisci will be sutured to the capsule of the native joint. The custom-matched allografts will be obtained by MTF Biologics, New Jersey, USA.The surgeons will carry out the initial 10 cases, and the cost will be borne by the Patent. Will take liability medical insurance for the patients to be treated if there are any complications. If the TOCR fails patients will undergo standard TKR and will be covered by the Insurance and Sponsors. The failure of the procedure could be infection which will be treated by antibiotics on out patient basis. As postoperatively patients will have routine physical therapy to strengthen the muscles and proper gait training for one month. The there is a failure of union then a bone graft can be further augmented and worse is to take out the allografts and perform the standard Total knee replacement. All patients will be instructed to report immediately to the hospital if any side effects are noted. Depending on the adverse effects, patients will continue or stop further treatment. All patients without or with adverse events will be followed for 36 months from the time they were operated on. All Adverse Events (AEs) were noted at every visit and were graded based on the intensity (mild, moderate, or severe) and relevance (serious, non-serious). Standard cuts of the Femur or Tibia in TKR. Schematic image of the post fixation in TOCR. Cadaveric Allografts of the Femur and Tibial Plateau. FIGURE I: Standard cuts of the Femur or Tibia in TKR.FIGURE II: Schematic image of the post fixation in TOCR Cadaveric TOCR. Figure IV: Cadaveric Allografts of the Femur and Tibial Plateau after fixation. Post-surgery patients will have the routine mobilization protocol by physical therapy as for standard TKR.

Inclusion criteria

• Being between 45 and 70 years of age of either gender. (OAK is common in this Age group)
• Diagnosed with OAK with Kellgren and Lawrence Grading III and IV.
• No ligamentous laxity and varus or valgus deformity. (In standard TKR patients with ligamentous laxity Constrained Condylar Knee (CCK) with intramedullary stem is used).
• Patients who wish to have an active lifestyle.
• Agreeing to participate and signing informed consent voluntarily.

Exclusion criteria

• Previous knee surgery within six months.
• Uncontrolled Diabetes Mellitus
• Chronic Kidney Disease. (Patients on hemodialysis)
• Metabolic bone disease. (Severe osteoporosis with T Score of -<3.5)
• Patients who will not consent to follow-up.
• Mental disorders and drug dependency (Patients who cannot understand the consent or the procedure of the TOCR).