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Study aim
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1- Determination of the brace effect in rehabilitation of knee replacement patients
2. Improved knee replacement patients
3. Reducing pain in knee replacement patients
4. Reducing costs after knee surgery if Brace is ineffective
5- Reduction of complications after knee surgery in case of postoperative brace complication
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Design
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This is a Randomize Clinical Trial study. The title of study is "Comparison of new immobilizer brace effect on rehabilitation of Total knee arthroplasty patients in Imam Khomeini and Khatam hospitals, 2017". Study is parallel and the target sample size is seventy that will be divided to control and case groups. The case group randomly will use Immobilizer Brace after operation for 8 days. Control and case groups will be followed for 30 days. The groups will be visited 4 times include Pre-op, 1 Day Post-op, 9 Day Post-op, 30 Day Post-op. We split the patients one by one into groups with brace and without brace. We won't had any previous decision about "which patients will be in what group". this study hasn't ant allocation.
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Settings and conduct
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This study will be performed on patients with Total Knee Arthroplasty in Imam Khomeini and Khatam al-Anbia hospitals in Tehran. All of these patients will be operated by one surgeon in two hospitals. Patients will be visited on the day before the surgery and the next day in the hospital. On the 9th and 30th days after surgery, patients will be visited at the clinic. the variables will be measured in all of the visits.
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
1. Fully aware of the type of intervention
2. Consent to Inclusion
3. Diseases such as Hemophilia and do not interfere with the study
4-Performing knee replacement surgery in Imam Khomeini and Khatam hospitals
5. Cooperate in the study
Exclusion criteria:
1. The patient refused to intervene and participate in the study
2. Interference effects in the study, including fracture, infection, and ...
3. Create a lack of access to any patients
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Intervention groups
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Intervention group: The patients randomly who will use Knee Immobilizer Brace after Total knee arthroplasty for 8 days.
Control group: The patients randomly who won't use Knee Immobilizer Brace after Total knee arthroplasty. They can move active and passive their knee in first 8 days after surgery.
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Main outcome variables
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The variables of study:
1- Knee Range of Motion pre-op and 30th days post-op
2- Knee Society Score Pre-op and 30th days post-op
3- The day, The patient can do SLR (Straight Leg Raise) Post-op.
4- Visual Analog Scale (VAS) of pain Pre-op, First Day post-op, 9th days post-op and 30th days post-op
5-Knee Society Functional Score Pre-op and 30th days post-op.
6-The Day, The Patient can do knee Extension Post-op.