Exploratory Study on Safety of PEEK Knee Prosthesis

September 3, 2022 updated by: You Wang, RenJi Hospital

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

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Shanghai, China, 200127
        • Renji Hospital,Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEK Knee Prosthesis
In this study, 10 subjects will be underwent total knee arthroplasty with 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measures at 12 months after surgery
Time Frame: 12 months
The expected incidence of device-related complications within 12 months after surgery is 0.
12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of other complications
Time Frame: 3,6, 12 months after surgery
These include infection, knee stiffness, venous thrombosis in the lower extremities, and pulmonary embolism.
3,6, 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: You Wang, MD, Renji Hospital
  • Principal Investigator: Teng Long, MD, Renji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2021

Primary Completion (Actual)

March 29, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 3, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • JSSZZK2020001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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