Exploratory Study on Safety of PEEK Knee Prosthesis

NCT04927104 | Unknown DMC

• 1 other identifier: JSSZZK2020001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis of Knee; Osteoarthritis of the Knee

Keywords

TKA; PEEK Knee Prosthesis

Outcome Measures

Primary Outcomes (1)

• Safety measures at 12 months after surgery

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

  12 months

Secondary Outcomes (5)

• X-ray examination

  At 3 and 12 months postoperatively

• CT

  one week and 12 months after surgery

• MRI

  3 and 12 months after surgery

• Hematological examination indexes 3 and 12 months after surgery

  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

Other Outcomes (1)

• Incidence of other complications

  3,6, 12 months after surgery

Study Arms (1)

PEEK Knee Prosthesis

EXPERIMENTAL

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

Device: PEEK Knee Prosthesis

Interventions

PEEK Knee Prosthesis DEVICE

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.

PEEK Knee Prosthesis

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.
• Other conditions, in the opinion of the Investigator, are inappropriate for participation in this clinical investigation.

Sponsors & Collaborators

• RenJi Hospital: lead
• Suzhou SinoMed Biomaterials Co., Ltd: collaborator

Study Sites (1)

Renji Hospital，Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• You Wang, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Teng Long, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis

Model Details: 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 Record Dates

• First Submitted: June 10, 2021
• First Posted: June 15, 2021
• Study Start: June 25, 2021
• Primary Completion: March 29, 2022
• Study Completion: December 30, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)