Clinical trial NCT02139345: TC-A Registration Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Avascular Necrosis
Keywords: Osteoarthritis
Rheumatoid arthritis
Post-traumatic arthritis
Avascular necrosis
AVN
Lead sponsor: Smith & Nephew Medical (Shanghai) Ltd
Sponsor class: INDUSTRY
First posted: 2014-05-15
Enrollment: 162
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subject was randomized to receive the treatment of investigational device or the comparator.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged between 50 and 75 years inclusive of Chinese ethnicity.
* 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:

* Bilateral knee disease with the anticipated need for bilateral knee implant during study participation (i.e., within the next 12 months).
* 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

Primary outcomes:
measure: The Original Knee Society Clinical Score (KSCS)
timeFrame: 1 year post-operative
Secondary outcomes:
measure: The Original Knee Society Functional Score (KSFS)
timeFrame: 1 year post-operative
measure: Revision for any reason
timeFrame: Up to 1 year post-operative
measure: Linear radiolucencies and radiographic abnormalities
timeFrame: Up to 1 year post-operative
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 1 year post-operative
measure: SF-12 Health Survey
timeFrame: 1 year post-operative
measure: Number of subjects with adverse events
timeFrame: Up to 1 year post-operative
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Ürümqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jianhao Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References: