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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT03169634
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing first time revision knee replacement for aseptic loosening or wear of the components
* Patient has signed an ethics committee approved consent form
* rTKR to be performed at The Royal Devon and Exeter Hospital
* AORI class 2 defects of femur and/or tibia
* Skeletally mature male or female
* Patient is willing and able to comply with postoperative scheduled clinical and radiological evaluations and rehabilitation
* Patient must be suitable for a rTKR with the Triathlon TS system i.e. must not have gross collateral ligament laxity
Exclusion Criteria:
* Refusal to consent to participate in the study
* Patients known to have an infected joint replacement prior to revision surgery
* Patients identified with an unexpected infected joint replacement identified per-operatively
* AORI class 1 defects of tibia or femur where metaphyseal cone fixation is not indicated
* AORI class 3 defects of tibia and femur where distal femoral replacement or proximal tibial replacement is required.
* Cases of ligamentous instability where condylar knee revision is not indicated
* Patient is diagnosed with a systemic disease or metabolic disorder leading to progressive bone deterioration
* Patient has a neuromuscular or neurosensory deficiency
* Patients undergoing patella revision in isolation
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03169634
Study Brief:
Protocol Section:
NCT03169634