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IRCT20260523069503N1 IRCT 2026-06-16 I-Tech Company Safety assessment of I-Tech Prostheses (Iranian Company) in Patients with Knee Osteoarthritis Safety assessment of I-Tech Prostheses (Iranian Company) in Patients with Knee Osteoarthritis Following Total Knee Arthroplasty, at Shafa Yahyaian Hospital: A Phase-1 Clinical Trial 2026-07-23 anticipated 15 Recruiting https://irct.ir/trial/90788 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 knee osteoarthritis. Intervention group: Patients with knee osteoarthritis grade 3 or 4 K-L who underwent TKA with I-Tech prosthesis Iranian company. Yes - There is a plan to make this available What will be shared: All the necessary information will be published in the article extracted from this study, and more information can be obtained through correspondence and requests from the responsible author. When: Access period begins after results are Published. To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: The use of data for scientific and research activities will be permitted in consultation with the corresponding author. Where to obtain: Dr. Abolfazl Bagherifard - Shafa Yahyaian Hospital - Tehran, Shohada Square, Mojahedin Islam Street, not far from the Parliament building, opposite the gas station, Shafa Yahyaian Hospital - Postal Code: 1157637131 - Phone: 021 3354 2001-bagherifd@gmail.com How to obtain: Official email request to the corresponding author stating the reasons for the request from an academic email - after review within one to two business weeks Comments:
public Mohammad Hassanzadeh
Shafa Yahyaeian hospital, next to the Islamic Council, Mujahideen Islam Street, Tehran
Tehran Iran (Islamic Republic of) 1157637139 +98 21 3354 2001 mu_h22@yahoo.com Iran University of Medical Sciences scientific Abolfazl Bagherifard
Shafa Yahyaeian hospital, next to the Islamic Council, Mujahideen Islam Street,Tehran
Tehran Iran (Islamic Republic of) 1157637139 +98 21 3354 2001 bagherifd@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) age between 45-65 years Knee osteoarthritis grade 3 or 4 Kellgren Lawrence (diagnosis based on standing knee X-Ray) knee joint malalignment less than 30 degrees ( based on 3-joint view radiograph) Visual analog scale equal or more than 5 Written informed consent 45 years 65 years Both BMI > 35 Coagulopathic diseases or use of anticoagulant medications Proven immune system defect History of cancer or active cancer Uncontrolled underlying diseases [including: diabetes (HbA1c >8.5)] or organ failure [including: liver (ALT, AST >100 U/L), kidney (Cr>2), heart (EF<45%)] Need for corticosteroids Positive viral tests (including: HIV Ab+/HBSAg/ HTLV1,2 Ab+/ HCV Ab+/ VDRL+) Participating in another clinical trial at the same time Severe inflammation of the knee joint as a result of infection (septic arthritis) or a history of knee joint infection Substance abuse Lack of sufficient cooperation in carrying out the plan and necessary follow-up M17 Osteoarthritis of knee Treatment - Devices Intervention group: Patients with knee osteoarthritis grade 3 or 4 K-L who underwent TKA with I-Tech prosthesis Iranian company Pain after TKA. Timepoint: 4 weeks, 3, 6 and 12 months after surgery. Method of measurement: Using VAS questionnare. Quality of life after TKA. Timepoint: 3, 6 and 12 months after surgery. Method of measurement: (KSS:Knee society score - WOMAC:Western Ontario and McMaster Universities Osteoarthritis Score,- Kujala Anterior Knee Pain Scale. I-Tech Company Approved 2026-04-28 Ethics committee of Iran University of Medical Sciences Shafa Yahyaian Hospital, next to the Islamic Counci, Mujahideen Islam Street, Baharestan Sq,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)