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Exploratory Study on Safety of PEEK Knee Prosthesis

Primary Purpose

Rheumatoid Arthritis of Knee, Osteoarthritis of the Knee

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEEK Knee Prosthesis
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis of Knee focused on measuring TKA, PEEK Knee Prosthesis

Eligibility Criteria

55 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Renji Hospital，Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEEK Knee Prosthesis

Arm Description

In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2021
Last Updated
September 3, 2022
Sponsor
RenJi Hospital
Collaborators
Suzhou SinoMed Biomaterials Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04927104
Brief Title
Exploratory Study on Safety of PEEK Knee Prosthesis
Official Title
Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Suzhou SinoMed Biomaterials Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis of Knee, Osteoarthritis of the Knee
Keywords
TKA, PEEK Knee Prosthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEK Knee Prosthesis
Arm Type
Experimental
Arm Description
In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis.
Intervention Type
Device
Intervention Name(s)
PEEK Knee Prosthesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety measures at 12 months after surgery
Description
The expected incidence of device-related complications within 12 months after surgery is 0.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
X-ray examination
Description
At 3 and 12 months postoperatively, the prosthesis observed for clear lines and signs of loosening.
Time Frame
At 3 and 12 months postoperatively
Title
CT
Description
The wear of the prosthesis measured one week and 12 months after surgery.
Time Frame
one week and 12 months after surgery
Title
MRI
Description
Inflammation and effusion around the prosthesis assessed 3 and 12 months after surgery.
Time Frame
3 and 12 months after surgery
Title
Hematological examination indexes 3 and 12 months after surgery
Description
Including: blood routine, liver and kidney function, erythrocyte sedimentation rate, C-reactive protein
Time Frame
3 and 12 months after surgery
Title
Excellent and good rates of the KSS knee scoring system at 3,6, 12 months postoperatively
Description
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.
Time Frame
3,6, 12 months after surgery
Other Pre-specified Outcome Measures:
Title
Incidence of other complications
Description
These include infection, knee stiffness, venous thrombosis in the lower extremities, and pulmonary embolism.
Time Frame
3,6, 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You Wang, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teng Long, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital，Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Exploratory Study on Safety of PEEK Knee Prosthesis

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