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Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a MRI generated cutting guide called Otismed. All patients have an MRI so both groups will be unaware of which surgical technique is used. All patients receive the usual pre-op care and same type of replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. Patients will be informed of which surgical technique they were randomized to at the conclusion of the study.
Objective(s):
Primary:
Compare the surgical and clinical outcomes between patients receiving total knee replacement after random assignment to one of two groups:
Secondary:
Evaluate the cost benefit ratio related to the two different cutting guide uses.
Research Plan: All patients that are referred to orthopedics, are eligible for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate. Patients will be randomly assigned to either the standard or the Otismed group. All patients will have a MRI of the knee. Patients and the research staff conducting measurements will be blinded to the type of cutting guide used for the surgery.
Methods: The study will be a randomized trial with the patient and data collector blinded to type of cutting guide used for the surgical procedure. The study will be conducted at one site and enrollment goal is 100 patients. Data collection will be done preoperatively and at 4 wks, 3 months, 6 months, one year and two year. Established instruments, the (Western Ontario and McMaster Universities Osteoarthritis Index) Womac and Oxford Knee Score, will be used. Measurements will be done to evaluate ROM (Range Of Motion) and assess post-op recovery. Surgical data and hospitalization data will be used for analysis of costs. Statistical analysis will be used for comparison of the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Usual standard cutting guide for TKA (Total Knee Arthroscopy) |
|
| Arm 2 | Experimental | Otismed MRI generated cutting guide for TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard cutting guide for TKA | Device | Use of the usual cutting guide for surgical replacement of a diseased knee |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient scores on Oxford, Womac, and Knee Society scores | 4 week, 3 mo. 6 mo. 1 yr. 2 yr. |
| Measure | Description | Time Frame |
|---|---|---|
| Leg alignment based on Long Leg CT scans | Post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold G. Dossett, MD MBA | Carl T. Hayden VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl T. Hayden VA Medical Center | Phoenix | Arizona | 85012 | United States | ||
| VA Salt Lake City Health Care System, Salt Lake City, UT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24986944 | Background | Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812. | |
| 37003458 | Derived | Dossett HG, Arthur JR, Makovicka JL, Mara KC, Bingham JS, Clarke HD, Spangehl MJ. A Randomized Controlled Trial of Kinematically and Mechanically Aligned Total Knee Arthroplasties: Long-Term Follow-Up. J Arthroplasty. 2023 Jun;38(6S):S209-S214. doi: 10.1016/j.arth.2023.03.065. Epub 2023 Mar 30. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 11, 2019 | |
| Reset | May 1, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2019 | May 1, 2019 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Otismed MRI generated cutting guide for TKA | Device | Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee |
|
|
| Salt Lake City |
| Utah |
| 84148 |
| United States |
| D012216 |
| Rheumatic Diseases |