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| Name | Class |
|---|---|
| InGeneron, Inc. | INDUSTRY |
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The purpose of this research study is to evaluate the cause of thigh pain after knee replacement. Different surgical techniques will be used to help determine the cause of thigh pain, and all surgical techniques are accepted and produce good clinical results.
This research study will be a randomized study in which patients volunteer participate. "Randomized" means the patients who received the new treatment are chosen at random, similar to flipping a coin. Several factors have been identified as possible sources of thigh pain after surgery: use of a tourniquet around the thigh to control bleeding during surgery; use of an intramedullary rod during surgery or quadriceps muscle strain. Participants will be randomized into surgical groups that use/do not use a tourniquet and use/do not use intramedullary rod during surgery. A subset of participants in all surgical groups will have a MRI to look for quadriceps muscle strain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tourniquet used with intramedullary rod | Experimental | Patients will undergo a total knee replacement with a tourniquet and intramedullary rod. |
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| No tourniquet with intramedullary rod | Experimental | Patients will undergo a total knee replacement without a tourniquet and with an intramedullary rod. |
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| Tourniquet without intramedullary rod | Experimental | Patients will undergo a total knee replacement with a tourniquet and without an intramedullary rod. |
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| No tourniquet without intramedullary rod | Experimental | Patients will undergo a total knee replacement without a tourniquet nor an intramedullary rod. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee replacement | Procedure | Total knee replacement (TKA) |
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| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcomes Survey (KOOS) | Survey | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on Numerical Rating Scale | Pain scale from 0-10 with 0 representing no pain and 10 representing maximum pain. | up to 3 months |
| Knee swelling | Physician evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory W Stocks, MD | Fondren Orthopedic Group L.L.P. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondren Orthopedic Group, L.L.P. | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| up to 3 months |
| Knee Range of Motion | Goniometer measurement | up to 3 months |
| Number of Patients with Adverse Events as a Measure of Safety | Adverse events | up to 3 months |
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |