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:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT01301950
Eligibility Criteria:
Inclusion Criteria:
* Subject is male or female and between the ages of 18 and 80 years old, inclusive.
* Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
* Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy
* Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures.
* Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch™ instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture are consistent with TruMatch™ instrumentation.
Exclusion Criteria:
* The Subject is a woman who is pregnant or lactating.
* The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
* The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
* The Subject has previously had a prosthetic knee replacement device (any type) of the affected knee.
* The Subject requires simultaneous bilateral total knee replacements.
* The Subject had a contralateral TKA and that knee was previously entered in the study.
* Subject in whom the surgeon intends to implant a knee prosthesis that is not in the PFC Sigma primary knee system.
* Subject who has inflammatory arthritis.
* Subject who has a Body Mass Index (BMI) of ≥ 40. (Please see Table 2-1: Definition of Terms, for BMI definition and calculation formulas).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01301950
Study Brief:
Protocol Section:
NCT01301950