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Safety and Efficacy of Newly Developed Knee Prosthesis for Knee Arthroplasty

NCT03184129 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-02-09

No results posted yet for this study

Summary

To verify and assess the safety and efficacy of newly developed knee prosthesis (Wuhan Yijiabao Biomaterial Co., Ltd.) in total knee arthroplasty.

Conditions

  • Knee Disease

Interventions

DEVICE

trial group

Patients with knee disease who will undergo knee arthroplasty will be randomized into trial group. The patients from the trial group will receive newly developed knee arthroplasty with knee prostheses purchased from Wuhan Yijiabao Biomaterial Co., Ltd..

DEVICE

control group

Patients with knee disease who will undergo knee arthroplasty will be randomized into control group. The patients from the control group will receive knee arthroplasty with knee prostheses purchased from Beijing AKEC Medical Co., Ltd., Beijing, China (approved by China Food and Drug Administration).

Sponsors & Collaborators

  • Taihe Hospital

    lead OTHER

Principal Investigators

  • Taifang Gong, Ph.D · Taihe Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-09-01
Completion
2018-11-30

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 NCT03184129 on ClinicalTrials.gov