Clinical trial NCT04927104: Exploratory Study on Safety of PEEK Knee Prosthesis
Official title: Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis of Knee
Osteoarthritis of the Knee
Keywords: TKA
PEEK Knee Prosthesis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Suzhou SinoMed Biomaterials Co., Ltd
First posted: 2021-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

* 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 .

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Safety measures at 12 months after surgery
timeFrame: 12 months
Secondary outcomes:
measure: X-ray examination
timeFrame: At 3 and 12 months postoperatively
measure: CT
timeFrame: one week and 12 months after surgery
measure: MRI
timeFrame: 3 and 12 months after surgery
measure: Hematological examination indexes 3 and 12 months after surgery
timeFrame: 3 and 12 months after surgery
measure: Excellent and good rates of the KSS knee scoring system at 3,6, 12 months postoperatively
timeFrame: 3,6, 12 months after surgery
Other outcomes:
measure: Incidence of other complications
timeFrame: 3,6, 12 months after surgery
Locations:
city: Shanghai
country: China
facility: Renji Hospital，Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: RenJi Hospital
name: You Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RenJi Hospital
name: Teng Long, MD
role: PRINCIPAL_INVESTIGATOR
References: