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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01305356
Eligibility Criteria:
KEY INCLUSION CRITERIA:
* at least 18 years old and considered skeletally mature
* diagnosed with degenerative joint disease (DJD) affecting the hindfoot due to a congenital or acquired deformity, osteoarthritis, rheumatoid arthritis, post- traumatic arthritis or ankylosing spondylitis of the ankle, subtalar, calcaneocuboid, and/or talonavicular joints
* requires one of the following hindfoot fusion proceduress with supplemental bone graft/substitute: ankle fusion (tibiotalar), subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints) OR double fusions (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints)
* fusion site able to be rigidly stabilized with no more than 3 screws across the fusion site
* supplemental pins or staples allowed
* supplemental screws external to the fusion site(s) allowed
* signed informed consent document, independent, ambulatory, and can comply with all post-operative evaluations and visits
KEY EXCLUSION CRITERIA:
* undergone previous fusion surgery at the proposed location, i.e., revision of a failed fusion
* more than one previous procedure at the involved joints
* retained hardware spanning the joint(s) intended for fusion
* procedure anticipated to require plate fixation (including claw plates), IM nails or more than 3 screws to achieve rigid fixation based on pre-op planning
* procedure expected to require more than 9cc of graft material based on pre-op planning
* procedure expected to require structural bone graft, allograft, bone graft substitute, platelet rich plasma (PRP) or bone marrow aspirate
* procedure expected to require a pantalar fusion, i.e., fusion of ankle plus all hindfoot joints (talonavicular, subtalar, and calcaneocuboid) or an ankle fusion in combination with any hindfoot fusion
* radiographic evidence of bone cysts, segmental defects or growth plate fracture near the fusion site that could negatively impact the proposed fusion procedure
* tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed surgical site
* pre-existing sensory impairment, e.g., diabetics with baseline sensory impairment, which limits ability to perform objective functional measurements and may be at risk for complications
\- diabetics not sensitive to the 5.07 monofilament (Semmes-Weinstein) are to be excluded
* metabolic disorder known to adversely affect the skeleton other than primary osteoporosis or diabetes, e.g., renal osteodystrophy or hypercalcemia
* use of chronic medications known to affect the skeleton, e.g., glucocorticoid usage \> 10mg/day
* pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to perform objective functional measurements
* physically or mentally compromised, e.g., current treatment for a psychiatric disorder, senile dementia, Alzheimer's disease, etc., to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant
* allergic to yeast-derived products or bovine collagen or other bovine-sourced products
* received an investigational therapy within 30 days of proposed surgery or during the follow-up phase of the study
* is a prisoner, known or suspected transient or a history of drug/alcohol abuse within the 12 months prior to screening
* pregnant or intending to become pregnant within 12 months of the study procedure
* morbidly obese defined as BMI \> 45 kg/m2
* currently has an acute infection at the surgical site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01305356
Study Brief:
Protocol Section:
NCT01305356