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IRCT20160809029286N5 IRCT 2020-04-21 Joint Reconstruction Research Center The comparison between Intramedullary and Extramedullary tibial guides on preserving lower limb length in TKA patients. The Effect of Intramedullary vs Extramedullary Tibial Guides on the Alignment of Lower Extremity following Total Knee Arthroplasty (TKA): randomized clinical trial 2018-09-01 anticipated 70 Complete https://irct.ir/trial/46976 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the permuted balanced blocks method will be used. In this method, six balanced blocks (1 to 6) are defined regarding the two interventions of the study (A, B) including AABB, BBAA, ABAB, BABA, ABBA, and BAAB. The patients are divided into 21 groups of four patients. The patients’ numbers are inserted from 1 to 84 in a column using MS Excel software. In another column, the group of each patient is inserted, for example: patients 1 to 4 as group 1, patients 5 to 8 as group 2, …, patients 81 to 84 as group 21. In another Excel sheath, the groups are inserted from 1 to 21, and the blocks are inserted across each group from 1 to 6 in order till the end. In the next column, non-repeated random numbers are inserted using the “RANDL()” command. Subsequently, the order of the blocks is randomly changed. According to the block assigned with each group, the intervention regarding each patient is determined. For example, if group 1 is assigned with “AABB”, the interventions will be as follows: Patient 1, A; Patient 2, A; Patient 3, B; Patient 3, B, Blinding description: The patient and assessor who will gather the data, will be blinded about the type of treatment modality (Double-Blind). N/A lower Limb alignment following TKA. Intervention 1: Intervention group no. 1. : Intramedullary tibial guide. The Intramedullary tibial guide in TKA surgery will be the first intervention. In total knee arthroplasty for insertion of tibial component of prosthesis, we will need a tibial guide to achieve the neutral alignment of lower limb. There are two standard method in achieving the alignment including intramedullary (Tibial intramedullary guide nail) and Extramedullary guides. The Intramedullary method uses the tibial canal and anatomical axis in achieving true lower limb alignment. This standard method is more accurate especially in high BMI patients but has some complication in the patients with tibial deformity such as perioperative fractures. Intervention 2: Intervention group no. 2. : Extramedullary tibial guide. The Extramedullary tibial guide in TKA surgery will be the Second intervention. In total knee arthroplasty for insertion of tibial component of prosthesis, we need a tibial guide to achieve the neutral alignment of lower limb. There are two standard methods in achieving the alignment including intramedullary (Tibial intramedullary guide nail) and Extramedullary guides. The Extramedullary method uses the tibial shaft and metatarsi bone 2 as a guide in achieving true lower limb alignment. This standard method is faster and easier without complication but there is controversy in accuracy of Extramedullary. Yes - There is a plan to make this available What will be shared: The Effect of Intra- vs. Extramedullary Tibial Guides on the Alignment of Lower Extremity following Total Knee Arthroplasty When: January 2021 To whom: MD Conditions: not any more conditions Where to obtain: Email : a.moharramy@gmail.com How to obtain: In two weeks Comments:
public Alireza Moharrami
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran , IRAN
Tehran Iran (Islamic Republic of) 1955743849 +98 21 6119 0000 a-moharrami@student.tums.ac.ir Tehran University of Medical Sciences scientific Dr Seyed Mohammad Javad Mortazavi
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6653 1354 smjmort@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Primary Total Knee Arthroplasty Praimary Knee osteoarthritis no limit no limit Both The patients with Major Comorbidities (Heart failure, CVA, DM, MI,...) Revision Total knee Arthroplasty Unicompartment Knee Arthroplasty The knee osteoarthritis due to Trauma, Hemophilia, Septic Arthritis, Inflammatory Diseases such as RA, SLE, and other rheumatologic diseases BMI more than 40 The patients with knee Valgus Deformity M17 Osteoarthritis of knee Treatment - Surgery Treatment - Surgery Intervention group no. 1. : Intramedullary tibial guide. The Intramedullary tibial guide in TKA surgery will be the first intervention. In total knee arthroplasty for insertion of tibial component of prosthesis, we will need a tibial guide to achieve the neutral alignment of lower limb. There are two standard method in achieving the alignment including intramedullary (Tibial intramedullary guide nail) and Extramedullary guides. The Intramedullary method uses the tibial canal and anatomical axis in achieving true lower limb alignment. This standard method is more accurate especially in high BMI patients but has some complication in the patients with tibial deformity such as perioperative fractures. Intervention group no. 2. : Extramedullary tibial guide. The Extramedullary tibial guide in TKA surgery will be the Second intervention. In total knee arthroplasty for insertion of tibial component of prosthesis, we need a tibial guide to achieve the neutral alignment of lower limb. There are two standard methods in achieving the alignment including intramedullary (Tibial intramedullary guide nail) and Extramedullary guides. The Extramedullary method uses the tibial shaft and metatarsi bone 2 as a guide in achieving true lower limb alignment. This standard method is faster and easier without complication but there is controversy in accuracy of Extramedullary Range of Motion. Timepoint: Pre-op, 3 month , last Post-op. Method of measurement: Goniometer. Knee Society Score. Timepoint: Pre-op, 3 month , last Post-op. Method of measurement: Knee Society Scoring (0-100). Knee Society Functional Score. Timepoint: Pre-op, 3 month , last Post-op. Method of measurement: Knee Society Functional Scoring (0-100). Pain. Timepoint: Pre-op, 3 month , last Post-op. Method of measurement: VAS (visual analog scale) 1-10. Lateral distal femoral angle (LDFA). Timepoint: Pre-op, 3 month Post-op. Method of measurement: With 3 joint alignment view x-ray will be calculated by MediCAD software. Medial proximal tibial angle (MPTA). Timepoint: Pre-op, 3 month Post-op. Method of measurement: With 3 joint alignment view x-ray will be calculated by MediCAD software. Mechanical femoral mechanical tibial or Varus angle (MFMTA or VA). Timepoint: Pre-op, 3 month Post-op. Method of measurement: With 3 joint alignment view x-ray will be calculated by MediCAD software. Joint line convergence angle (JLCA). Timepoint: Pre-op, 3 month Post-op. Method of measurement: With 3 joint alignment view x-ray will be calculated by MediCAD software. - Approved 2017-07-15 Ethics committee of Tehran University of Medical science- Imam khomeini hospital Ethics committee, Imam Khomeini complex Hospital(Tehran university of Medical Science) , keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)