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This is a prospective, randomized, multicenter clinical study to compare the safety and efficacy of TC-A PS total knee system with TC-PLUS Solution PS total knee system in Chinese subjects.
Osteoarthritis (OA), also known as degenerative joint disease or hyperostosis, is the most common cause of knee arthritis. Pain, dyskinesia and disability induced by osteoarthritis impact severely on the subject's health and quality of life. Knee osteoarthritis is very common in the elderly population. As life expectancy has increased, the incidence of osteoarthritis rose significantly during the 20th century. For people over 60 years of age, approximately 50% show signs of osteoarthritis on x-rays, among which 35% -50% show clinical signs. For people over the age of 75, 80% had osteoarthritis symptoms.
There has been an increase in imported knee prostheses during the past decade, so that surgeons now have more choices of implants. However, the high cost of imported prostheses has become a barrier to the development of TKA in China and caused many OA subjects requiring immediate TKA to have to delay or miss their surgery. The development and promotion of high-quality domestic joint implants and surgical instruments is the key to the development of TKA technique in China.
The primary objective of this study is to demonstrate non-inferiority of subjects implanted with the TC-A PS total knee system compared to a randomized concurrent control group of subjects implanted with the TC-PLUS Solution PS total knee system in terms of Knee Society Clinical Score (KSCS) at 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TC-A PS | Experimental | Subject will be implanted with the TC-A PS Total Knee Replacement System |
|
| TC-PLUS Solution PS | Active Comparator | Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-A PS Total Knee Replacement System | Device | Subject will be implanted with the TC-A PS Total Knee Replacement System |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Original Knee Society Clinical Score (KSCS) | The Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. For the results, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor. | 1 year post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| The Original Knee Society Functional Score (KSFS) | The Knee Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For the result, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor. | 1 year post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianhao Lin, Professor | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | 100730 | China | ||
| The First Hospital of Jilin University |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Subject was randomized to receive the treatment of investigational device or the comparator.
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Investigator who assesses KSS score is blinded to the subject's treatment.
| TC-PLUS Solution PS Total Knee Replacement System | Device | Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System |
|
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| Revision for any reason |
Revision for any reason will be assessed and documented up to 1 year post-operative. |
| Up to 1 year post-operative |
| Linear radiolucencies and radiographic abnormalities | Radiographic measurements will be taken of linear radiolucencies and the radiographs will be evaluated for any abnormalities. | Up to 1 year post-operative |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of subjects with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. | 1 year post-operative |
| SF-12 Health Survey | The SF-12 Health Survey was first developed in 1995 as a shorter version of the SF-36 Health Survey used for measuring the overall health condition of the general population. The usefulness of SF-12 is improved by its simplicity and less time needed for completion, and it has a good reliability on the evaluation of quality of life. The SF-12v2 Health Survey is a 12-item generic Health-Related Quality of Life measure consisted of eight subscales: Physical functioning (PF), Role physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role emotional (RE) and Mental health (MH); and two composite summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All subscales and summary scores were ranged from 0-100. The higher the SF-12 score, the better the HRQOL outcome. | 1 year post-operative |
| Number of subjects with adverse events | Safety will be evaluated by collecting the frequency and nature of all postoperative adverse events | Up to 1 year post-operative |
| Changchun |
| Jilin |
| 100035 |
| China |
| The First Teaching Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |