NCT04927104

Exploratory Study on Safety of PEEK Knee Prosthesis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-06-25
• Primary completion: 2022-03-29
• Completion: 2022-12-30
• First posted: 2021-06-15
• Last updated: 2022-09-07

Locations

1 site across 1 country: China