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A prospective study will be performed to compare the clinical outcome after total knee arthroplasty (TKA) using two different alignment systems: an extramedullary system versus an intramedullary system. The extramedullary femoral alignment system is newly designed. These two systems are used to make the distal femoral resection in 100 patients in a random order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male Extramedullary | Experimental | In this group, patients are male and femoral extramedullary resection would be used. |
|
| Female Extramedullary | Experimental | In this group, patients are female and femoral extramedullary resection would be used. |
|
| Male Intramedullary | Active Comparator | In this group, patients are male and femoral Intramedullary resection would be used. |
|
| Female Intramedullary | Active Comparator | In this group, patients are female and femoral Intramedullary resection would be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distal femoral resection in total knee arthroplasty | Procedure | EM and IM alignment systems are used to make the distal femoral cut in a random order. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Imaging tests | Evaluate the X-ray changes. Measuring the hip-knee-ankle (HKA) angle by x-ray films | pre surgery and 3, 12 months post surgery |
| Assess the changes of KSS scores | KSS scores will be recorded. | pre surgery and 3, 12 months post surgery |
| Assess the changes of SF-36 scores | SF-36 scores will be recorded | pre surgery and 3, 12 months post surgery |
| Assess the changes of WOMAC scores | WOMAC scores will be recorded. | pre surgery and 3, 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| deep vein thrombosis (DVT) | DVT was diagnosed by 3 experienced radiologists 96 according to Robinov group's criterion. | pre surgery and 3, 12 months post surgery |
| Range of knee motion | Range of knee motion will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Jiang, PhD | Contact | +8613605192953 | qingj@nju.edu.cn | |
| Zhihong Xu, PhD | Contact | +8613912988032 | xuzhihongjoint@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhihong Xu | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21575792 | Background | Meding JB, Berend ME, Ritter MA, Galley MR, Malinzak RA. Intramedullary vs extramedullary femoral alignment guides: a 15-year follow-up of survivorship. J Arthroplasty. 2011 Jun;26(4):591-5. doi: 10.1016/j.arth.2010.05.008. | |
| 22610529 | Background | Nakahara H, Matsuda S, Okazaki K, Tashiro Y, Iwamoto Y. Sagittal cutting error changes femoral anteroposterior sizing in total knee arthroplasty. Clin Orthop Relat Res. 2012 Dec;470(12):3560-5. doi: 10.1007/s11999-012-2397-1. Epub 2012 May 19. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 11, 2020 | |
| Unrelease | Jan 15, 2020 | |
| Release | Jan 16, 2020 | |
| Reset | Jan 27, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 11, 2020 | Jan 15, 2020 | |||
| Jan 16, 2020 |
| 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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| pre surgery and 3, 12 months post surgery |
| 24912573 | Background | Kim CW, Seo SS, Kim JH, Lee HJ, Lee CR. Factors affecting the osteolysis around the components after posterior-stabilized total knee replacement arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1863-9. doi: 10.1007/s00167-014-3088-0. Epub 2014 Jun 11. |
| Jan 27, 2020 |
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |