Exploratory Study on Safety of PEEK Knee Prosthesis

NCT ID: NCT04927104

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-25
• Study Completion Date: 2022-12-30

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.

Conditions

Rheumatoid Arthritis of Knee; Osteoarthritis of the Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEEK Knee Prosthesis

In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis.

Group Type: EXPERIMENTAL

PEEK Knee Prosthesis

Intervention Type: DEVICE

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.

Interventions

PEEK Knee Prosthesis

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou SinoMed Biomaterials Co., Ltd

INDUSTRY

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

You Wang

Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

You Wang, MD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Teng Long, MD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Renji Hospital，Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Countries

China

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

JSSZZK2020001

Identifier Type: -

Identifier Source: org_study_id