Evaluation of Knee Immobilizer Use on Immediate Postoperative Clinical Outcomes Following Total Knee Arthroplasty

Determining the effect of using an immobilizing knee brace immediately after Total Knee Arthroplasty on the functional and clinical outcomes of hospitalized patients.

Parallel-group RCT, 72 TKA candidates (two groups of 36). Randomization via blocked allocation. Outcome assessor and data analyst are single-blinded. Phase: 3.

This research is an RCT conducted at Imam Khomeini Hospital (RA), Urmia. TKA candidates are divided into two groups: Intervention: Use of an extension-locked knee brace for 8 days post-surgery. Control: Standard care without the brace. Outcomes include pain, analgesic use, range of motion, and function, assessed pre-operatively and on days 1, 7, and 14 post-op. The outcome assessor and data analyst are blinded to group allocation (single-blind).

Inclusion: Knee OA patients, TKA candidates, 50+, consenting & cooperative. Exclusion: BMI>40, gait neuromuscular disorders, severe chronic illness, acute surgical complications.

Intervention Group: Immediately after transfer to the ward, patients receive an Extension-Locked Knee Brace, used for 8 days post-operatively per protocol. Patients receive full training on application and precautions. Control Group: Patients do not receive a knee brace or external support, only standard post-TKA care (pain control, initial rehabilitation, routine physiotherapy). Medication, analgesia protocols, and physiotherapy programs are identical for both groups.

The primary outcomes of this study include the assessment of post-operative pain severity using the VAS scale, the amount of opioid analgesic consumption, knee range of motion, patient’s functional ability, and the incidence of early post-operative complications such as falls and knee instability.

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.

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).