Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT01923805
Eligibility Criteria:
Inclusion Criteria:
* Patients must meet all of the following criteria in order to be considered appropriate candidates for participation in the study:
1. Is scheduled for RTKA (may be the second stage/reimplantation of a two-stage revision for infection);
2. Is able and willing to provide voluntary written informed consent for participation in the study and able to comply with protocol requirements;
3. Is between the ages of 18 and 85 at the time of surgery. Both male and female will be included;
4. Is physically and mentally willing and able to comply with the clinical and evaluation follow-up schedule;
Exclusion Criteria:
* The following exclusion criteria address safety and follow-up concerns or contraindications that could confound the study. If a patient exhibits any one of the following criteria, the patient is not eligible to participate in this study:
1. Is known to be sensitive to any materials of bovine origin;
2. Is undergoing a bilateral RTKA;
3. Is undergoing a single component revision (i.e. tibial or femoral component only)
4. Is undergoing a polyethylene revision only
5. Is predonating autologous blood;
6. Have a preoperative platelet count of less than 100,000
7. Have a previous history of venous thromboembolism or deep vein thrombosis;
8. Have a medical condition requiring anticoagulation
9. Currently using Coumadin;
10. Have a history of Heparin induced thrombocytopenia or Lovenox induced thrombocytopenia;
11. Have a history of rheumatoid arthritis or inflammatory arthritis;
12. Have peripheral vascular disease;
13. Have evidence of bleeding or metabolic-based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder;
14. Have a history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from the study if a baseline INR is greater than 1.3 or APTT greater than 32.4;
15. Have a history of failed treatment for abuse of, or are actively abusing, illegal drugs, solvents, or alcohol;
16. Have a systemic infection or infection at site of surgery;
17. Is a prisoner;
18. Is pregnant or nursing and;
19. Have a condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Exclusion Criteria (Intra-operative)
1. Clinical evidence of cancer and/or infection at surgical site
2. Use during the procedure of any other approved or unapproved product for the purpose of hemostasis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01923805
Study Brief:
Protocol Section:
NCT01923805