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Exploratory Study on Safety of PEEK Knee Prosthesis

NCT04927104 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-09-07

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis of Knee
  • Osteoarthritis of the Knee

Interventions

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.

Sponsors & Collaborators

  • Suzhou SinoMed Biomaterials Co., Ltd

    collaborator INDUSTRY

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • You Wang, MD · RenJi Hospital

  • Teng Long, MD · RenJi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2022-03-29
Completion
2022-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04927104 on ClinicalTrials.gov