Exploratory Study on Safety of PEEK Knee Prosthesis

Shanghai Jiao Tong University

Status

Active, not recruiting

Conditions

Osteoarthritis of the Knee

Rheumatoid Arthritis of Knee

Treatments

Device: PEEK Knee Prosthesis

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04927104

JSSZZK2020001

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

55 to 74 years old

Volunteers

No Healthy Volunteers

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.