Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
162 participants
INTERVENTIONAL
2014-09-23
2016-11-23
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TC-A PS
Subject will be implanted with the TC-A PS Total Knee Replacement System
TC-A PS Total Knee Replacement System
Subject will be implanted with the TC-A PS Total Knee Replacement System
TC-PLUS Solution PS
Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System.
TC-PLUS Solution PS Total Knee Replacement System
Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System
Interventions
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TC-A PS Total Knee Replacement System
Subject will be implanted with the TC-A PS Total Knee Replacement System
TC-PLUS Solution PS Total Knee Replacement System
Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject presents with primary osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or avascular necrosis of knee joint requiring primary total knee replacement with the PS knee system.
* Subject who is able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained by signing and dating an EC-approved consent form.
* Subject who is able to understand this clinical study, co-operates with the investigational procedures and is willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.
* Life expectancy of subject is over 2 years.
Exclusion Criteria
* Subject has known or suspected metal sensitivity.
* Subject is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders, which cannot provide adequate support and/or fixation to the prosthesis.
* Subject is severely obese (BMI\>35).
* Subject has hip arthritis and/or replacement.
* Subject had an active infection or sepsis (treated or untreated)
* Subject has conditions that may compromise implant stability or postoperative recovery (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
* Subject has an emotional or neurological condition that would affect their ability or willingness to participate in the study (e.g. mental illness, mental retardation).
* Subject is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder. For examples, subject is on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or has acquired immunodeficiency syndrome (AIDS).
* Subject is a woman who is pregnant or lactating，or intends to become pregnant during the course of the study.
* Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
* Subject was enrolled in another investigational drug, biologic, or device study in the last 12 months.
* Known alcohol and/or drug abuse
50 Years
75 Years
ALL
No
Sponsors
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Smith & Nephew Medical (Shanghai) Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jianhao Lin, Professor
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Nanjing First Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Peking University People's Hospital
Beijing, , China
Countries
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Other Identifiers
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13-4060-04
Identifier Type: -
Identifier Source: org_study_id