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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT01984450
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years to 65 years.
* Diagnosed with articular cartilage defect in the knee (ICRS/Outerbridge grade III/IV cartilage lesions as assessed on MRI scan).
* No other significant medical co-morbidities, as assessed by pre-operatively, that could interfere with surgery results of trial eg. Hypertension, COPD etc.
* Participant has clinically acceptable laboratory and ECG tests at pre-assessment clinic.
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Up to 3 lesions of sizes 2-8 square cm.
Exclusion Criteria:
* Generalized and/or inflammatory arthritis
* Active joint inflammation
* More than 5 degrees of varus or valgus deformity
* Age below 18 and over 65 years
* More than 4 lesions
* Lesions more than 8 square cm.
* Significant co-morbidities or classified as ASA grade 3/4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01984450
Study Brief:
Protocol Section:
NCT01984450