Exploratory Study on Safety of PEEK Knee Prosthesis

Not Applicable

Active, not recruiting

• Conditions: Rheumatoid Arthritis of Knee; Osteoarthritis of the Knee
• Interventions: Device: PEEK Knee Prosthesis

• Registration Number: NCT04927104
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-15
• Study Start: 2021-06-25
• Primary Completion: 2022-03-29
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-03
• Last Update Posted: 2022-09-07
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEK Knee Prosthesis	PEEK Knee Prosthesis	In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis.

Primary Outcome Measures

Name	Time	Method
Safety measures at 12 months after surgery	12 months	The expected incidence of device-related complications within 12 months after surgery is 0.

Secondary Outcome Measures

Name	Time	Method
CT	one week and 12 months after surgery	The wear of the prosthesis measured one week and 12 months after surgery.
X-ray examination	At 3 and 12 months postoperatively	At 3 and 12 months postoperatively, the prosthesis observed for clear lines and signs of loosening.
MRI	3 and 12 months after surgery	Inflammation and effusion around the prosthesis assessed 3 and 12 months after surgery.
Excellent and good rates of the KSS knee scoring system at 3,6, 12 months postoperatively	3,6, 12 months after surgery	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.
Hematological examination indexes 3 and 12 months after surgery	3 and 12 months after surgery	Including: blood routine, liver and kidney function, erythrocyte sedimentation rate, C-reactive protein

Trial Locations

Locations (1)

Renji Hospital，Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China