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AUGMENT
®
North American Pivotal Trial
Data Summary
Bone Graft
(rhPDGF-BB/β-TCP)
Purpose
To evaluate the safety and efficacy of
AUGMENT® Bone Graft as an alternative to
autograft in ankle and hindfoot arthrodesis.
Investigational Device
AUGMENT® Bone Graft
» rhPDGF-BB solution (0.3 mg/ml)
»β-TCP granules (1000-2000 µm)
Clinical Trial Design
»Prospective
»Randomized
»Controlled
»Multi-center
»Statistically-powered
Key Inclusion Criteria
Ankle or hindfoot arthrodesis requiring
supplemental bone graft. Individual joint
fusions and multiple joint fusions (e.g. triple
arthrodesis, double fusions) including:
» Tibiotalar arthrodesis
» Subtalar arthrodesis
» Calcaneocuboid arthrodesis
» Talonavicular arthrodesis
Principal Investigator
Christopher DiGiovanni, MD
Massachusetts General Hospital
AUGMENT
®
Bone Graft
Key Exclusion Criteria
» Revision fusion surgery
» Diabetes with pre-existing sensory
impairment (non-sensate to 5.07 SemmesWeinstein monofilament)
» Chronic use of medication known to affect
the skeleton (e.g. glucocorticoid usage
>10 mg/day)
» Pregnancy or females intending to become
pregnant during the study period
» Morbid obesity (BMI >45 kg/m2)
» Plate fixation (Plates were excluded for
imaging and hardware standardization
purposes.)
BioMimetic Therapeutics, LLC. | 389 Nichol Mill Lane • Franklin, TN 37067 USA | 615-236-4527 • 877-670-2684 | www.biomimetics.com
Wright Medical Technology, Inc. | 1023 Cherry Rd. • Memphis, TN 38117 USA | 901-867-9971 • 800-238-7117 | www.wright.com
™Trademarks and ®Registered marks of Wright Medical Technology, Inc. AUGMENT® is a registered trademark of Biomimetic Therapeutics, LLC.
©2015 Wright Medical Technology, Inc. All rights reserved. MKS003-03
Surgical Technique/Methods
The surgical approach was standardized
across all treatment centers. Each patient was
randomized (2:1) to receive AUGMENT® Bone
Graft or autograft to serve as an enhancement
to bone healing at the fusion site.
Autograft was harvested from either the iliac
crest, proximal or distal tibia, calcaneus, or
locally, per investigator preference. Screw
fixation (maximum three screws per joint) was
chosen to reduce the likelihood of radiographic scatter on CT scans and to standardize the
fixation hardware. Closure was meticulously
performed to maximize graft containment.
In general, the postoperative course
included patients remaining non weightbearing in a cast for six weeks, after which
time they were advanced to a walking boot
and permitted limited weight-bearing.
Patient Demographics
397 patients were evaluated at 37 centers
across the United States and Canada. 75% of
patients in both groups had one or more risk
factors for poor healing:
» Obesity (BMI >30 kg/m2): 48%
» Smoking History: 24%
» Prior Surgery: 23%
» Diabetes: 11%
(continued on reverse)
AUGMENT
®
North American Pivotal Trial
Data Summary
Bone Graft
(rhPDGF-BB/β-TCP)
Conclusion
For the first time, the published results
demonstrate Level 1 evidence that an
engineered biologic is a safe and effective
alternative to autograft in promoting
ankle and hindfoot fusion when tested in a
rigorously designed and executed clinical trial.
Moreover, patients treated with AUGMENT®
Bone Graft were spared the prolonged donor
site pain and morbidity associated with the
autograft harvest procedure.
Clinical Outcomes
Measures
Pivotal Trial Results†‡
24 Week Results*
All Patients (N=397)
P=0.010
100%
AUGMENT® Bone Graft
(N=260, 394)
24 Weeks
52 Weeks
Yes (p=0.012)
Yes (p<0.001)
AOFAS
Ankle-Hindfoot Score
Yes (p<0.001)
Yes (p<0.001)
SF-12 Mean PCS
Yes (p<0.001)
Yes (p=0.015)
Fusion Site Pain
Yes (p=0.001)
Yes (p<0.001)
Weight Bearing Pain
Yes (p=0.016)
Yes (p<0.001)
P<0.001
P=0.038
Part No.
Description
K20003010 AUGMENT® Bone Graft
Volume
3cc
AUGMENT® Bone Graft
(N=260)
Autograft (N=137)
75%
50%
25%
P<0.001
P<0.001
CT Fusion Rates
All Patients
(N=397)
CT Fusion Rates
All Joints
(N=597)
Clinical Healing
Therapeutic
Failure Rate**
Graft Harvest Site
Pain
† DiGiovanni C, et al. Recombinant human platelet-derived growth factorBB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): An alternative to
autogenous bone graft. J Bone Joint Surg Am. 2013; 95: 1184-92.
‡ FDA did not base its approval of AUGMENT® Bone Graft on radiologic
findings from the pivotal study, but instead relied on clinical outcomes.
Ordering Information
P=0.003
Autograft (N=137, 203)
Statistically Equivalent
Improvements in Clinical
Outcomes Measures†
(Non-inferiority established)
Foot Function Index
52 Week Results*
All Patients (N=397)
Please see the AUGMENT® Bone Graft Instructions
for Use for more information regarding the
surgical technique, contraindications, warnings,
precautions, and storage instructions.
BioMimetic Therapeutics, LLC. | 389 Nichol Mill Lane • Franklin, TN 37067 USA | 615-236-4527 • 877-670-2684 | www.biomimetics.com
Wright Medical Technology, Inc. | 1023 Cherry Rd. • Memphis, TN 38117 USA | 901-867-9971 • 800-238-7117 | www.wright.com
™Trademarks and ®Registered marks of Wright Medical Technology, Inc. AUGMENT® is a registered trademark of Biomimetic Therapeutics, LLC.
©2015 Wright Medical Technology, Inc. All rights reserved. MKS003-03
P<0.001
0%
Clinical Healing
Therapeutic
Failure Rate**
P<0.001
Graft Harvest Site
Pain
* All P values are for non-inferiority, except for graft harvest site pain,
which is for superiority.
**Therapeutic failure rate was defined as delayed union or nonunion
requiring surgery or further therapeutic intervention.