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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00424567
Eligibility Criteria:
Inclusion Criteria:
* Type IIIA or IIIB fracture
* Fracture gap \< 6 cm.
* Distance of \> 4 cm from joint
* No clinical signs of infection at the wound site or fracture site.
* Adult patients \>18 years of age.
* Male patients or female patients who are not pregnant or lactating.
* Patients must have normal organ and marrow function as defined below:
1. Leukocytes \>=3000/microliters
2. Absolute neutrophil count \>=1500/microliters
3. Platelets \>=100,000/microliters
4. AST (SGOT)/ALT (SGPT) \<2.5 x institutional limits
5. Creatinine within normal limits or creatinine clearance calculated)\>=60 mL/min/1.73 square miter with creatinine above institutional normal.
* Patients able to give informed consent
Exclusion Criteria:
* Other long bone fractures, e.g clavicle
* Patients unable to discontinue ethanol use after surgery including those requiring pharmacologic adjuvant assistance.
1. Although not an exclusion criteria, the attending physician shall discuss with the patient the advantages of discontinuing smoking cigarettes and/or cigars during the term of the study including discontinuing the use of pharmacologic adjuvant assistance such as nicotine suppression.
2. The use or discontinuance of ethanol and/or cigarettes/cigars will be noted in the patient's case report forms.
* Patients who require corticosteroid anti-inflammatory therapy after surgery.
* Patients with genetic metabolic bone disease such as hypophosphatasia, or metabolic bone disorders such as primary or secondary hyperparathyroidism caused by chronic renal insufficiency or other disorders.
* Patients unable to tolerate general anesthesia defined as an ASA criteria of 0 or 1.
* Patients on systemic antibiotics for suspected wound or fracture site infection.
* Patients with diabetes.
* Glasgow score of \< 13.
* Injury severity score of \> 25.
* Allergy to protein products derived from mammalian sources (horse, bovine or porcine) required in the ex-vivo cell production process.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00424567
Study Brief:
Protocol Section:
NCT00424567