IRCT20260408069035N1 IRCT 2026-05-24 Oroumia University of Medical Sciences splinted knee brace after total knee replacement surgery Evaluation of Knee Immobilizer Use on Immediate Postoperative Clinical Outcomes Following Total Knee Arthroplasty 2026-05-22 anticipated 72 Recruiting https://irct.ir/trial/89426 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: short-term (8-day) use of a locked-hinged knee brace post-TKA, employing full blinding of outcome assessors and data analysts to mitigate bias, while assessing comprehensive functional and safety outcomes, Randomization description: Participants will be randomized using block randomization with fixed block sizes of four. The random allocation sequence will be generated by computer software, and within each block, patients will be randomly assigned to either Group A or Group B. To prevent selection bias, allocation concealment will be ensured using the SNOSE method (Sequentially Numbered, Opaque, Sealed Envelopes). The random sequence will be placed inside opaque, sequentially numbered, sealed envelopes, which will be opened only after participant enrollment, Blinding description: Following TKA surgery and patient stabilization, participants will be randomly allocated to either the intervention or control group using a randomization table and block randomization. This process will be managed by an independent party using sealed, opaque envelopes. As blinding patients and the treatment team is not feasible, only the outcome assessor and data analyst will be blinded to group allocation to minimize bias (Single-blind). 3 Total Knee Arthroplasty. Intervention 1: Patients in this group will be placed in an extension-locked knee brace immediately after transfer to the ward. The intervention protocol includes continuous use of the brace for 8 days after surgery. To ensure adherence to the protocol, the patient will be provided with necessary training on how to properly fasten the brace, duration of use, and safety precautions. Intervention 2: Control group: Patients in this group will be placed under the Standard of Care protocol and will not use any external support or knee brace. This care includes pain management, medication protocols, initial rehabilitation, and routine physiotherapy programs. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I will make a decision to publish after the completion of the project and according to the results