Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04927104
Study type Interventional
Source RenJi Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date June 25, 2021
Completion date December 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT03277066 - A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis Phase 2
Recruiting NCT03090698 - Outcomes of Injections in Patients Waiting for Total Knee Replacement Phase 4
Completed NCT02556710 - A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee Phase 3
Completed NCT02242435 - A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis Phase 3
Withdrawn NCT02237846 - Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis Phase 1/Phase 2
Completed NCT02096393 - Patient Specific Instrumentation in TKR N/A
Completed NCT01849445 - Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study N/A
Completed NCT01704157 - A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device N/A
Active, not recruiting NCT01374230 - Long-Term Multicenter Evaluation of the E1® Tibial Bearing N/A
Not yet recruiting NCT01270412 - Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis Phase 2/Phase 3
Completed NCT02156440 - Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee Phase 2
Completed NCT01410409 - Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement N/A
Completed NCT01207115 - A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee Phase 2
Completed NCT00970008 - Exploring Massage Benefits for Arthritis of the Knee Phase 2
Completed NCT00988091 - Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee Phase 3
Completed NCT01331278 - A Comparative Study of Knee Systems Phase 4
Completed NCT00792727 - HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain Phase 3
Completed NCT00531427 - Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee Phase 3
Completed NCT00449696 - Gel-200 Versus Placebo in Osteoarthritis of the Knee Phase 3
Completed NCT04145011 - Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain N/A