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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01450332
Eligibility Criteria:
Inclusion Criteria:
1. Patient is \>= 18 years old
2. Patient has a ruptured ACL
3. Operated knee has full range of motion and no swelling
4. Patient understands the study requirements and the treatment procedures and rehabilitation and provides written Informed Consent before any study-specific tests or procedures are performed.
5. The patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic.
Exclusion Criteria:
1. Skeletal immaturity
2. Pregnancy
3. Patient with:
* Uncontrolled systemic hypertension
* Severe uncontrolled Diabetes Mellitus
* Epiphyses That Have Not Yet Closed
* Periarticular or Patella Fracture
* History of Metabolic Bone Disease (e.g.., Osteoporosis, Rickets)
* Crystal deposition disease, e.g., gout
* Inflammatory joint disease, e.g., rheumatoid arthritis
* Severe degenerative joint disease
* Known neoplastic disease
* HIV positive
* Current steroid therapy in excess of prednisone 5 mg/day
* Other severe, life-threatening systemic disease or any medical condition that interferes with their ability to participate in a rehabilitation program
4. The subject has participated in, or is planned to participate in, any investigational drug or device study within the past 30 days and for the duration of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01450332
Study Brief:
Protocol Section:
NCT01450332