Primary OsteoarthritisNCT02139345
TC-A Registration Study
A study testing TC-A PS Total Knee Replacement System and TC-PLUS Solution PS Total Knee Replacement System in people with Primary Osteoarthritis and Rheumatoid Arthritis, run by Smith & Nephew Medical (Shanghai) Ltd at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Primary Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
- What is being tested?
- TC-A PS Total Knee Replacement System and TC-PLUS Solution PS Total Knee Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 4 sitesChina
- Study dates
- 23 Sep 2014to 23 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University People's Hospital
Beijing, 100044
The First Hospital of Jilin University
Changchun, Jilin, 100035
Nanjing First Hospital
Nanjing, Jiangsu, 100730
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
About this 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
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.
Read the 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.
- Conditions
- Primary Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis
- Being tested
- TC-A PS Total Knee Replacement System, TC-PLUS Solution PS Total Knee Replacement System
- Keywords
- Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Avascular necrosis, AVN
- Medical subject headings
- Arthritis, Rheumatoid, Osteonecrosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-A PS Total Knee Replacement SystemDevice
Also called TC-A PS
Subject will be implanted with the TC-A PS Total Knee Replacement System
TC-PLUS Solution PS Total Knee Replacement SystemDevice
Also called TC-PLUS Solution PS
Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System
| Study group | Role | What they receive |
|---|---|---|
| TC-A PS | Experimental | Subject will be implanted with the TC-A PS Total Knee Replacement System Receives: Device: 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. Receives: Device: TC-PLUS Solution PS Total Knee Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post-operative
Secondary outcomes (6)
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.
Measured: 1 year post-operative
Revision for any reason
Revision for any reason will be assessed and documented up to 1 year post-operative.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study start23 Sep 2014
- Primary completion23 Nov 2016
- Study completion23 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subject was randomized to receive the treatment of investigational device or the comparator.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Medical (Shanghai) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianhao Lin, Professor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139345
- Sponsor's protocol ID
- 13-4060-04
- Status last verified
- Nov 2017
- First submitted
- 7 May 2014
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02139345
- Acronym / sponsor ID
- 13-4060-04
- Conditions
- Primary Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis
- Keywords
- Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Avascular necrosis, AVN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Smith & Nephew Medical (Shanghai) LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 23 Nov 2016 (actual)
- Study completion
- 23 Nov 2016 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subject was randomized to receive the treatment of investigational device or the comparator.
| Arm | Type | Receives |
|---|---|---|
| TC-A PS | Experimental | Device: TC-A PS Total Knee Replacement SystemSubject will be implanted with the TC-A PS Total Knee Replacement System |
| TC-PLUS Solution PS | Active comparator | Device: TC-PLUS Solution PS Total Knee Replacement SystemSubject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-A PS Total Knee Replacement SystemAlso: TC-A PSSubject will be implanted with the TC-A PS Total Knee Replacement System | Device | TC-A PS |
| TC-PLUS Solution PS Total Knee Replacement SystemAlso: TC-PLUS Solution PSSubject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System | Device | TC-PLUS Solution PS |
Primary outcome
The Original Knee Society Clinical Score (KSCS)
Time frame: 1 year post-operative
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.
6 secondary outcomes
The Original Knee Society Functional Score (KSFS)
Time frame: 1 year post-operative
Revision for any reason
Time frame: Up to 1 year post-operative
Linear radiolucencies and radiographic abnormalities
Time frame: Up to 1 year post-operative
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 1 year post-operative
SF-12 Health Survey
Time frame: 1 year post-operative
Number of subjects with adverse events
Time frame: Up to 1 year post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Primary Osteoarthritis
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Study Comparing Osteoarthritis Programs
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Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
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DEXA Bone Density Analysis of the CoreHip® Prosthesis System
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Condylar Offset and Outcomes in Primary Total Knee Arthroplasty
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A Randomized Comparison of the Efficacy of the IPACK Block Versus the Popliteal Plexus Block for Posterior Knee Analgesia, in Patients Undergoing a Total Knee Arthroplasty and Receiving a Continuous Distal Femoral Triangle Block
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianhao Lin, Professor principal investigator
Peking University People's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TC-A PS Total Knee Replacement System and TC-PLUS Solution PS Total Knee Replacement System in people with Primary Osteoarthritis and Rheumatoid Arthritis, run by Smith & Nephew Medical (Shanghai) Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Original Knee Society Clinical Score (KSCS) (time frame: 1 year post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.