In This SectionTexas Health Research & Education Institute
Disease or Condition
Orthopedics / Bone graft
Augment Injectable Compared to Autologous Bone Graft (Orthopedics Surgery)
This study is being conducted to see whether Augment Injectable is safe and effective as a bone regeneration(new bone growth) system for promoting bone fusions compared to using autologous bone graft (your own bone).
The subject has signed the Ethics Committee approved Informed Consent Form specific to this study prior to enrollment.
The subject has a minimum baseline VAS full weight bearing pain score of 40 mm on a 100mm scale without assistive devices.
The subject is 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 subtalar, calcaneocuboid, and/or talonavicular joints.
The subject requires hindfoot fusion with supplemental bone graft/substitute, requiring one of the following procedures:
a. Subtalar fusion (talocalcaneal).
b. Calcaneocuboid fusion.
c. Talonavicular fusion.
d. Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints).
e. Double fusions (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints)
The fusion site is able to be rigidly stabilized with no more than 3 screws across the fusion site. Supplemental pins or staples may be used. Supplemental screws external to the fusion site(s) are also allowed.
The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits.
The subject is at least 21 years of age and considered to be skeletally mature.
The subjects must be able to read, write and speak English.
The subject has undergone previous fusion surgery of the proposed site (i.e., revision of failed fusion attempt).
The subject has had a previous surgery of the hindfoot; with the exception of procedures that do not have significant compromise of the peri-articular soft tissue. Examples of procedures that do not create significant compromise of the peri-articular soft tissue and which would not exclude the subject include the following:
a. Diagnostic arthrotomy and debridement
b. Arthrotomy for removal of osteophytes
c. Open reduction internal fixation for tibial fractures or foot fracture
d. Ligament/ tendon repair or reconstruction
e. Hardware removal
The subject has had more than one previous procedure at the involved joints.
The subject has retained hardware spanning the joint(s) intended for fusion.
The procedure is anticipated to require use of plate fixation (including claw plates), intramedullary rods (or nails), or more than three (3) screws across the fusion site to achieve rigid fixation as determined by the pre-operative assessment (including clinical and radiologic).
The procedure is anticipated to require use of more than 9 cc of graft material as determined by the pre-operative assessment (including clinical and radiologic).
The fusion site requires structural bone graft, allograft, bone graft substitute, platelet-rich plasma (PRP), or bone marrow aspirate for completion of the fusion procedure.
The subject requires a pantalar fusion (i.e. fusion of the ankle plus all hindfoot joints [talonavicular, subtalar, and calcaneocuboid]) or an ankle fusion in combination with any hindfoot fusion.
The subject requires subsequent surgery of the concomitant hindfoot within 12 months of study treatment.
The subject has bilateral degenerative joint disease that may require fusion or surgical repair of the contralateral hindfoot within 12 months of study enrollment.
There is radiographic evidence of bone cysts, segmental defects or growth plate fracture around the fusion site that may negatively impact bony fusion.
The subject has tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or are currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment™ Injectable Bone Graft implantation site.
The subject has a pre-existing sensory impairment (e.g., diabetics with baseline sensory impairment), which limits the ability to perform objective functional measurements and may place subjects at risk for complications. For the purpose of this protocol, diabetics that are not sensitive to the 5.07 monofilament (Semmes-Weinstein) are to be excluded.
The subject has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis or diabetes (e.g., renal osteodystrophy or hypercalcemia).
The subject uses chronic medications known to affect the skeleton (e.g., glucocorticoid usage >10mg/day).
The subject has a pre-fracture neuromuscular or musculoskeletal deficiency, which limits the ability to perform objective functional measurements.
The subject has vascular insufficiency (large or small vessel disease) or kidney insufficiency.
The subject has a diagnosis or history of bi-polar disorder, schizophrenia, suicidal ideation, post traumatic stress disorder, senile dementia or Alzheimer’s disease as defined via standard, recognized methods such as the DSM-IV criteria, to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant.
The subject has an allergy to yeast-derived products.
The subject has an allergy to bovine collagen and/or other bovine source medication, supplements or products.
The subject has received an investigational therapy or approved therapy for investigational use within 30 days of surgery or during the follow-up phase of this study.
The subject is a prisoner, or is known or suspected to be transient.
The subject has a history of substance abuse within the 12 months prior to screening for study entry.
The subject is pregnant or a female intending to become pregnant within 12 months of the study procedure. A pregnancy test, urine or blood will be performed no earlier than 2 days before the scheduled surgery, e.g., during the required pre-op testing, to any female unless she is post-menopausal, has been sterilized or is practicing a medically-accepted method of contraception.
The subject is deemed morbidly obese (BMI >45 kg/m2).
The subject refuses to discontinue using tobacco products prior to surgery.
The subject currently has an acute infection at the surgical site.
The subject has a history of anaphylaxis or of multiple non-environmental allergies.
The subject medical history contraindicates the use of a tourniquet during the surgical procedure.