Research

A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

IRB Number: 11040
(inactive trial)

Institutional Review Board, Hospital for Special Surgery

May 05, 2011

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Andrew J. Elliott, MD

Co-Investigators

Inga Zhygalo

Summary

The purpose of this study is to look at the safety and efficacy of a synthetic injectable bone graft (Augment™ Injectable Bone Graft) compared to Autologous Bone Graft (your own bone) in this hindfoot fusion. The study device, Augment™ Injectable physically fills bone voids by providing a biocompatible product to physically fill bone defects and allows for new bone formation by your own bone.  All materials used in the components have been previously approved/cleared by the U.S. Food and Drug Administration (FDA).
A total of 8-10 subjects will participate in this study at HSS. Overall participation will be over a period of 24 months in which you will be asked to come in 12 times.  Most visits are expected to last 2 hour
 

Inclusion/Exclusion Criteria

Inclusion Criteria:

Patients who meet the following criteria may be included in the study, if they present with all of the following:
1) The subject has signed the IRB approved Informed Consent Form specific to this study prior to enrollment.
2) The subject has a minimum baseline VAS full weight bearing pain score of 40 mm on
a 100mm scale without assistive devices.
3) The subject is diagnosed with degenerative joint disease (DJD) affecting the hindfoot
due to a congenital or acquired deformity, osteoarthritis, rheumatoid arthritis, posttraumatic arthritis or ankylosing spondylitis of the subtalar, calcaneocuboid, and/or
talonavicular joints.
4) The subject requires hindfoot fusion with supplemental bone graft/substitute,
requiring one of the following procedures:
• Subtalar fusion (talocalcaneal)
• Calcaneocuboid fusion
• Talonavicular fusion
• Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
• Double fusions (any combination of any two of the following: subtalar,
talonavicular and calcaneocuboid joints)
5) 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.
6) The subject is independent, ambulatory, and can comply with all post-operative
evaluations and visits.
7) The subject is at least 21 years of age and considered to be skeletally mature.


Exclusion Criteria:  

Subjects will be excluded from the study, if they present with any of the following:
1) The subject has undergone previous fusion surgery of the proposed site (i.e., revision or failed fusion attempt).
2) 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 periarticular
soft tissue and which would not exclude the subject include the following:
• Diagnostic arthrotomy and debridement
• Arthrotomy for removal of osteophytes
• Open reduction internal fixation for tibial fractures or foot fracture
• Ligament/ tendon repair or reconstruction
• Hardware removal
3) The subject has had more than one previous procedure at the involved joints.
4) The subject has retained hardware spanning the joint(s) intended for fusion.
5) 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).
6) 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).
7) The fusion site requires structural bone graft, allograft, bone graft substitute, plateletrich plasma (PRP), or bone marrow aspirate for completion of the fusion procedure
8) 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.
9) The subject requires subsequent surgery of the concomitant hindfoot within 12
months of study treatment.
10) The subject has bilateral degenerative joint disease that may require fusion or surgical repair of the contralateral hindfoot within 12 months of study enrollment.
11) There is radiographic evidence of bone cysts, segmental defects or growth plate
fracture around the fusion site that may negatively impact bony fusion.
12) 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.
13) 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.
14) The subject has a metabolic disorder known to adversely affect the skeleton, other
than primary osteoporosis or diabetes (e.g., renal osteodystrophy or hypercalcemia).
15) The subject uses chronic medications known to affect the skeleton (e.g.,
glucocorticoid usage >10mg/day).
16) The subject has a pre-fracture neuromuscular or musculoskeletal deficiency, which
limits the ability to perform objective functional measurements.
17) The subject has vascular insufficiency (large or small vessel disease) or kidney
insufficiency.
18) 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.
19) The subject has an allergy to yeast-derived products.
20) The subject has an allergy to bovine collagen and/or other bovine source medication, supplements or products.
21) 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.
22) The subject is a prisoner, or is known or suspected to be transient.
23) The subject has a history of substance abuse within the 12 months prior to screening for study entry.
24) 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.
25) The subject is deemed morbidly obese (BMI >45 kg/m2).
26) The subject refuses to discontinue using tobacco products prior to surgery.
27) The subject currently has an acute infection at the surgical site.
28) The subject has a history of anaphylaxis or of multiple non-environmental allergies.
29) The subject medical history contraindicates the use of a tourniquet during the surgical procedure.

Contact Information

Andrew J. Elliott, MD
elliotta@hss.edu
212.203.0740

IngaZhygalo
zhygaloi@hss.edu
212-774.7116



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