Rheumatoid Arthritis of KneeNCT04927104
Exploratory Study on Safety of PEEK Knee Prosthesis
A study testing PEEK Knee Prosthesis in people with Rheumatoid Arthritis of Knee and Osteoarthritis of the Knee, run by RenJi Hospital at 1 site in China.
Trial summary
In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes… Read more about this study
- Who is it for?
- Ages 55 to 74 years
- Conditions the study is for
- Rheumatoid Arthritis of Knee, Osteoarthritis of the Knee
- What is being tested?
- PEEK Knee Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2021to 30 Dec 2022
- 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 55 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 55 years of age or older and less than 74 years of age, younger subjects should have urgent need for surgery.
- Subjects skeletal maturity.
- Subjects appropriate for total knee replacement, such as noninflammatory degenerative joint diseases (such as osteoarthritis, traumatic arthritis, or ischemic necrosis); Inflammatory degenerative joint diseases (including rheumatoid arthritis); Correction of functional deformity.
- The diseased side knee appropriate for primary total knee arthroplasty .
- Subjects or guardian is willing and able to sign the informed consent form .
Who cannot join
- Subjects with knee instability or abnormal gait caused by neuromuscular insufficiency.
- Subjects with bilateral knee joint disease who are expected to require replacement of both knees during the course of the study (i.e., within the next 12 months) .
- Alcoholics, drug addicts and drug abusers.
- Subjects with severe diabetes (fasting blood glucose > 10mmol/L)
- Body Mass Index, BMI>35.
- Female subjects who are pregnant or lactating.
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- Subjects have disease limited their participation in the investigation or have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- In the month before inclusion, subjects who participated in clinical studies of other drugs, biological agents or medical devices and failed to meet the main research endpoints.
- Other conditions, in the opinion of the Investigator, are inappropriate for participation in this clinical investigation.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital，Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
About this study
Official title: Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis
In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
Read the detailed description
According to the involved person's biomedical research ethics review method "(national health and family planning commission (11)) and the medical and health institutions to carry out the researchers launched a clinical research management method" (draft) on request, for national key development plan required for research and development production of PEEK knee prosthesis for clinical trials. In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
Since this study is an exploratory study, all subjects will be retrospectively studied one year after the end of the study.
- Being tested
- PEEK Knee Prosthesis
- Keywords
- TKA, PEEK Knee Prosthesis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK Knee ProsthesisDevice
After subjects drop out of the study for any reason, the researchers can perform revision surgery using the prosthetic joint that is now routinely used.
| Study group | Role | What they receive |
|---|---|---|
| PEEK Knee Prosthesis | Experimental | In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis. Receives: Device: PEEK Knee Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures at 12 months after surgery
The expected incidence of device-related complications within 12 months after surgery is 0.
Measured: 12 months
Secondary outcomes (5)
X-ray examination
At 3 and 12 months postoperatively, the prosthesis observed for clear lines and signs of loosening.
Measured: At 3 and 12 months postoperatively
CT
The wear of the prosthesis measured one week and 12 months after surgery.
Measured: one week and 12 months after surgery
MRI
Inflammation and effusion around the prosthesis assessed 3 and 12 months after surgery.
Measured: 3 and 12 months after surgery
Hematological examination indexes 3 and 12 months after surgery
Including: blood routine, liver and kidney function, erythrocyte sedimentation rate, C-reactive protein
Measured: 3 and 12 months after surgery
Excellent and good rates of the KSS knee scoring system at 3,6, 12 months postoperatively
The full score of KSS is 100, above 85 is excellent, 70-84 is good, 60-69 is acceptable, and less than 60 is poor. Calculate the proportion of excellent and good grades.
Measured: 3,6, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start25 Jun 2021
- Primary completion29 Mar 2022
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis of KneeStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou SinoMed Biomaterials Co., Ltd
- Responsible party
- Principal investigator, You Wang, RenJi Hospital
- Investigators
- You Wang, MD, Principal investigator, RenJi HospitalTeng Long, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927104
- Sponsor's protocol ID
- JSSZZK2020001
- Status last verified
- Sep 2022
- First submitted
- 10 Jun 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis
- ClinicalTrials.gov ID
- NCT04927104
- Acronym / sponsor ID
- JSSZZK2020001
- Keywords
- TKA, PEEK Knee Prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Suzhou SinoMed Biomaterials Co., Ltd
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Jun 2021 (actual)
- 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.
In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
Detailed description
According to the involved person's biomedical research ethics review method "(national health and family planning commission (11)) and the medical and health institutions to carry out the researchers launched a clinical research management method" (draft) on request, for national key development plan required for research and development production of PEEK knee prosthesis for clinical trials. In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
Since this study is an exploratory study, all subjects will be retrospectively studied one year after the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| PEEK Knee Prosthesis | Experimental | Device: PEEK Knee ProsthesisIn this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 55 years of age or older and less than 74 years of age, younger subjects should have urgent need for surgery.
- Subjects skeletal maturity.
- Subjects appropriate for total knee replacement, such as noninflammatory degenerative joint diseases (such as osteoarthritis, traumatic arthritis, or ischemic necrosis); Inflammatory degenerative joint diseases (including rheumatoid arthritis); Correction of functional deformity.
- The diseased side knee appropriate for primary total knee arthroplasty .
- Subjects or guardian is willing and able to sign the informed consent form .
Key exclusion criteria (9 listed)
- Subjects with knee instability or abnormal gait caused by neuromuscular insufficiency.
- Subjects with bilateral knee joint disease who are expected to require replacement of both knees during the course of the study (i.e., within the next 12 months) .
- Alcoholics, drug addicts and drug abusers.
- Subjects with severe diabetes (fasting blood glucose > 10mmol/L)
- Body Mass Index, BMI>35.
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 |
|---|---|---|
| PEEK Knee ProsthesisAfter subjects drop out of the study for any reason, the researchers can perform revision surgery using the prosthetic joint that is now routinely used. | Device | PEEK Knee Prosthesis |
Primary outcome
Safety measures at 12 months after surgery
Time frame: 12 months
The expected incidence of device-related complications within 12 months after surgery is 0.
5 secondary outcomes
X-ray examination
Time frame: At 3 and 12 months postoperatively
CT
Time frame: one week and 12 months after surgery
MRI
Time frame: 3 and 12 months after surgery
Hematological examination indexes 3 and 12 months after surgery
Time frame: 3 and 12 months after surgery
Excellent and good rates of the KSS knee scoring system at 3,6, 12 months postoperatively
Time frame: 3,6, 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No
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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.
You Wang, MD principal investigator
RenJi Hospital
Teng Long, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK Knee Prosthesis in people with Rheumatoid Arthritis of Knee and Osteoarthritis of the Knee, run by RenJi Hospital at 1 site 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 9 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: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Safety measures at 12 months after surgery (time frame: 12 months). 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 7 Sep 2022.