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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT05325060
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects
* Subjects must be at least 18 years of age and there will be no maximum age limit. The subjects age must be considered suitable by the Investigator for a knee arthroplasty using either of the two systems available in the evaluation.
* Subjects, who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
* Subjects, who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigation procedures and are willing to return to the hopsital for all the required post-operative follow-ups.
* Subjects who require a knee arthroplasty for primary surgical management of the idiopathic osteoarthritis.
* Subjects, who in the opinion of the Investigator, are considered to be suitable for treatment with a NexGen LPS Flex Total Knee Replacement.
Exclusion Criteria:
* Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in the study
* Subjects who require revision total knee arthroplasty surgery
* Subjects with any tibial deformity requiring tibial component augmentation.
* Subjects whom, in the opinion of the Investigator, require a constratined prosthesis.
* Subjects with inflammatory polyarthritis.
* Subjects with disorders of the feet, ankles, hips, or spine caising significant abnormal gait or significant pain.
* Subjects with osteoarthritis of the contralateral knee causing significant abnormal gait or significant pain.
* Subjects with poorly functioning contralateral total knee replacement causing significant abnormal gait or significant pain. Subjects with a well functioning contralateral total knee replacement will not be excluded.
* Subjects with neurological conditions affecting movement.
* Subjects with a pathology which, in the opinion of the Investigator, will adversely affect healing.
* Subjects with other disorders which, in the opinion of the Investigator, will/could impair rehabilitation.
* Contra-indications for the use of the device, as detailed in the package insert.
* Women who are pregnant
* Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
* Subjects who are currently invovled in another clinical study with an investigational product.
* Subjects who are currently invovled in any injury litigation claims.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT05325060
Study Brief:
Protocol Section:
NCT05325060