Back to resultsTC-A Registration Study
Primary Purpose
Primary Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TC-A PS Total Knee Replacement System
TC-PLUS Solution PS Total Knee Replacement System
Sponsored by
About this trial
This is an interventional treatment trial for Primary Osteoarthritis focused on measuring Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Avascular necrosis, AVN
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
Sites / Locations
- Nanjing First Hospital
- The First Hospital of Jilin University
- The First Teaching Hospital of Xinjiang Medical University
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TC-A PS
TC-PLUS Solution PS
Arm Description
Subject will be implanted with the TC-A PS Total Knee Replacement System
Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Revision for any reason
Revision for any reason will be assessed and documented 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.
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.
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.
Number of subjects with adverse events
Safety will be evaluated by collecting the frequency and nature of all postoperative adverse events
Full Information
NCT ID
NCT02139345
First Posted
May 7, 2014
Last Updated
November 13, 2017
Sponsor
Smith & Nephew Medical (Shanghai) Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02139345
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 23, 2014 (Actual)
Primary Completion Date
November 23, 2016 (Actual)
Study Completion Date
November 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew Medical (Shanghai) Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis
Keywords
Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Avascular necrosis, AVN
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subject was randomized to receive the treatment of investigational device or the comparator.
Masking
Outcomes Assessor
Masking Description
Investigator who assesses KSS score is blinded to the subject's treatment.
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TC-A PS
Arm Type
Experimental
Arm Description
Subject will be implanted with the TC-A PS Total Knee Replacement System
Arm Title
TC-PLUS Solution PS
Arm Type
Active Comparator
Arm Description
Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System.
Intervention Type
Device
Intervention Name(s)
TC-A PS Total Knee Replacement System
Other Intervention Name(s)
TC-A PS
Intervention Description
Subject will be implanted with the TC-A PS Total Knee Replacement System
Intervention Type
Device
Intervention Name(s)
TC-PLUS Solution PS Total Knee Replacement System
Other Intervention Name(s)
TC-PLUS Solution PS
Intervention Description
Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System
Primary Outcome Measure Information:
Title
The Original Knee Society Clinical Score (KSCS)
Description
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.
Time Frame
1 year post-operative
Secondary Outcome Measure Information:
Title
The Original Knee Society Functional Score (KSFS)
Description
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.
Time Frame
1 year post-operative
Title
Revision for any reason
Description
Revision for any reason will be assessed and documented up to 1 year post-operative.
Time Frame
Up to 1 year post-operative
Title
Linear radiolucencies and radiographic abnormalities
Description
Radiographic measurements will be taken of linear radiolucencies and the radiographs will be evaluated for any abnormalities.
Time Frame
Up to 1 year post-operative
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
1 year post-operative
Title
SF-12 Health Survey
Description
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.
Time Frame
1 year post-operative
Title
Number of subjects with adverse events
Description
Safety will be evaluated by collecting the frequency and nature of all postoperative adverse events
Time Frame
Up to 1 year post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhao Lin, Professor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
100730
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
100035
Country
China
Facility Name
The First Teaching Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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