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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT00225095
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 60, inclusive
* In need of medial meniscectomy
* Normal axial alignment
* Stable knee- previous ligament reconstruction, if stable
* Removal of at least 50% of the affected portion of the medial meniscus
* Intact articular cartilage in posterior meniscal weight-bearing zone
* Willingness to follow normal post-operative rehabilitation
* Willingness to participate in follow-up for two years from the time of meniscectomy surgery
* Ability to understand and willingness to sign consent form
Exclusion Criteria:
* Pregnant or lactating
* ACL or other support structure damage confirmed at surgery
* Grade III or IV cartilage damage (Cartilage loss greater than 50% thickness in area \>15mm on weight-bearing aspect of femoral condyle or tibial plateau)
* Synvisc, steroid, or corticosteroid injections in preceding 3 months
* Diffuse synovitis at time of arthroscopy
* Inflammatory arthritis
* Oral steroid, methotrexate therapy
* Unable to follow post-operative exercise regimen or return for evaluations
* Active alcohol or substance abuse within 6 months of study entry
* Current and active tobacco product use
* Patient is positive for HIV
* Patient is positive for hepatitis (past history of Hepatitis A is allowed)
* Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
* Indwelling pacemaker
* Cerebral aneurysm clips
* Ear, eye and penile implants with avian components
* Electrical indwelling device such as bone stimulator
* Indwelling magnets as tissue expander for future implants
* Known allergy to avian, bovine or porcine protein
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00225095
Study Brief:
Protocol Section:
NCT00225095