Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Study Details
Study Description
Brief Summary
STUDY OBJECTIVES:
To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)
STUDY HYPOTHESIS:
Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness
STUDY RATIONALE:
To evaluate a fully synthetic bone graft material to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
STUDY DESIGN:
Prospective, randomized, controlled, non-inferiority, multi-center trial
NUMBER OF STUDY CENTERS:
25
NUMBER OF SUBJECTS:
299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3 separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01)
STUDY POPULATION:
Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure.
TREATMENT GROUPS:
Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment® Injectable Bone Graft
Subjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft).
ROUTE OF ADMINISTRATION:
Investigational device is manually implanted inside and around the fusion space to ensure Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space
STUDY DURATION:
Twenty-four month follow-up post-surgery
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Augment® Injectable Bone Graft Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) |
Device: Augment® Injectable Bone Graft
Implantation of up to 9cc of Augment® Injectable Bone Graft
|
| Active Comparator: Autologous bone graft Standard Rigid Fixation + Autologous bone graft |
Procedure: Autologous bone graft
Implantation of up to 9cc of autologous bone graft
|
Outcome Measures
Primary Outcome Measures
- Pain on Weight Bearing [Baseline, 9, 12, 16, 24, 36, and 52 weeks]
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Secondary Outcome Measures
- Foot Function Index (FFI) [Baseline, 9, 12, 16, 24, 36, and 52 weeks]
The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.
- AOFAS Hindfoot and Ankle Score [Baseline, 9, 12, 16, 24, 36, and 52 weeks]
Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.
- Fusion Site Pain [Baseline, 9, 12, 16, 24, 36, and 52 weeks]
Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
- SF-12 Physical Component Score [Baseline, 9, 12, 16, 24, 36, and 52 weeks]
The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tucson Orthopaedic Research Center | Tucson | Arizona | United States | 85712 |
| 2 | University of Arizona | Tucson | Arizona | United States | 85724 |
| 3 | California Pacific Medical Center | San Francisco | California | United States | 94118 |
| 4 | Illinois Bone & Joint Institute, Ltd. | Glenview | Illinois | United States | 60025 |
| 5 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 6 | Union Memorial Hospital | Baltimore | Maryland | United States | 21218 |
| 7 | Mid Michigan Orthopaedic Institute | East Lansing | Michigan | United States | 48823 |
| 8 | Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan | United States | 49525 |
| 9 | Desert Orthopaedic Center | Las Vegas | Nevada | United States | 89121 |
| 10 | University of Medicine & Dentistry of New Jersey | Newark | New Jersey | United States | 07101 |
| 11 | Hospital for Special Surgery | New York | New York | United States | 10021 |
| 12 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 13 | OrthoCarolina, PA | Charlotte | North Carolina | United States | 28207 |
| 14 | Cleveland Clinic Orthopaedic | Cleveland | Ohio | United States | 44195 |
| 15 | Orthopedic Foot & Ankle Center | Columbus | Ohio | United States | 43231 |
| 16 | Health Research Institute, Inc. | Oklahoma City | Oklahoma | United States | 73109 |
| 17 | The Rothman Institute | Philadelphia | Pennsylvania | United States | 19107 |
| 18 | Campbell Clinic / InMotion Orthopaedic Research Center | Memphis | Tennessee | United States | 38138 |
| 19 | Texas Health Research & Education Institute | Dallas | Texas | United States | 75231 |
| 20 | St. Luke's Episcopal Hospital | Houston | Texas | United States | 77030 |
| 21 | Life Mark Health Centre | Calgary | Alberta | Canada | |
| 22 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z1Y6 |
| 23 | Queen Elizabeth II Health Services | Halifax | Nova Scotia | Canada | B3H3A7 |
| 24 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1H8L6 |
| 25 | St. Michael's Hospital | Toronto | Ontario | Canada | M5C1R6 |
Sponsors and Collaborators
- BioMimetic Therapeutics
Investigators
- Study Director: Stephen Roach, Stryker Trauma GmbH
- Principal Investigator: Christopher DiGiovanni, MD, University Orthopaedics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BMTI-2010-01
- NCT01008891
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A propensity score matching analysis was performed in order to identify a single set of investigational and control subjects derived from the datasets (BMTI-2006-01, BMTI-2009-01, BMTI-2010-01) that were comparable and could be evaluated for the purpose of assessing the safety and effectiveness of AUGMENT® Injectable. |
| Arm/Group Title | Augment® Injectable Bone Graft | Autologous Bone Graft |
|---|---|---|
| Arm/Group Description | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) | Standard Rigid Fixation + Autologous bone graft |
| Period Title: Overall Study | ||
| STARTED | 132 | 167 |
| COMPLETED | 132 | 167 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Augment® Injectable Bone Graft | Autologous Bone Graft | Total |
|---|---|---|---|
| Arm/Group Description | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) Augment® Injectable Bone Graft: Implantation of up to 9cc of Augment® Injectable Bone Graft | Standard Rigid Fixation + Autologous bone graft Autologous bone graft: Implantation of up to 9cc of autologous bone graft | Total of all reporting groups |
| Overall Participants | 132 | 167 | 299 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
97
73.5%
|
109
65.3%
|
206
68.9%
|
| >=65 years |
35
26.5%
|
58
34.7%
|
93
31.1%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
62
47%
|
81
48.5%
|
143
47.8%
|
| Male |
70
53%
|
86
51.5%
|
156
52.2%
|
| Affected Foot/Ankle (Count of Participants) | |||
| Ankle fusion |
31
23.5%
|
46
27.5%
|
77
25.8%
|
| Subtalar fusion |
52
39.4%
|
59
35.3%
|
111
37.1%
|
| Calcaneocuboid fusion |
3
2.3%
|
0
0%
|
3
1%
|
| Talonavicular fusion |
6
4.5%
|
9
5.4%
|
15
5%
|
| Double fusion |
21
15.9%
|
17
10.2%
|
38
12.7%
|
| Triple arthordesis |
19
14.4%
|
36
21.6%
|
55
18.4%
|
| Ever smoked (Count of Participants) | |||
| No |
61
46.2%
|
83
49.7%
|
144
48.2%
|
| Yes |
71
53.8%
|
84
50.3%
|
155
51.8%
|
Outcome Measures
| Title | Pain on Weight Bearing |
|---|---|
| Description | Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). |
| Time Frame | Baseline, 9, 12, 16, 24, 36, and 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points. |
| Arm/Group Title | Augment® Injectable Bone Graft | Autologous Bone Graft |
|---|---|---|
| Arm/Group Description | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) | Standard Rigid Fixation + Autologous bone graft |
| Measure Participants | 132 | 167 |
| Baseline |
71.0
(2.0)
|
70.7
(1.8)
|
| Week 9 |
29.5
(2.9)
|
28.2
(2.5)
|
| Week 12 |
26.8
(2.5)
|
24.6
(2.2)
|
| Week 16 |
26.4
(2.4)
|
24.4
(2.1)
|
| Week 24 |
25.1
(2.4)
|
18.3
(2.1)
|
| Week 36 |
18.7
(2.3)
|
15.8
(2.0)
|
| Week 52 |
16.6
(2.4)
|
15.9
(2.1)
|
| Title | Foot Function Index (FFI) |
|---|---|
| Description | The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment. |
| Time Frame | Baseline, 9, 12, 16, 24, 36, and 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points. |
| Arm/Group Title | Augment® Injectable Bone Graft | Autologous Bone Graft |
|---|---|---|
| Arm/Group Description | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) | Standard Rigid Fixation + Autologous bone graft |
| Measure Participants | 132 | 167 |
| Baseline |
50.6
(1.6)
|
50.0
(1.4)
|
| 9 Weeks |
41.8
(1.7)
|
45.0
(1.5)
|
| 12 Weeks |
33.3
(1.8)
|
34.5
(1.6)
|
| 16 Weeks |
29.7
(2.0)
|
28.0
(1.7)
|
| 24 Weeks |
26.3
(1.8)
|
19.8
(1.6)
|
| 36 Weeks |
21.8
(1.8)
|
16.7
(1.6)
|
| 52 Weeks |
19.6
(1.9)
|
16.9
(1.6)
|
| Title | AOFAS Hindfoot and Ankle Score |
|---|---|
| Description | Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes. |
| Time Frame | Baseline, 9, 12, 16, 24, 36, and 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points. |
| Arm/Group Title | Augment® Injectable Bone Graft | Autologous Bone Graft |
|---|---|---|
| Arm/Group Description | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) | Standard Rigid Fixation + Autologous bone graft |
| Measure Participants | 132 | 167 |
| Baseline |
43.3
(1.5)
|
43.6
(1.3)
|
| 9 Weeks |
61.5
(1.1)
|
61.5
(1.0)
|
| 12 Weeks |
66.9
(1.3)
|
66.6
(1.1)
|
| 16 Weeks |
69.9
(1.3)
|
71.2
(1.1)
|
| 24 Weeks |
73.4
(1.5)
|
75.5
(1.3)
|
| 36 Weeks |
77.5
(1.5)
|
78.9
(1.3)
|
| 52 Weeks |
79.5
(1.6)
|
79.3
(1.4)
|
| Title | Fusion Site Pain |
|---|---|
| Description | Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). |
| Time Frame | Baseline, 9, 12, 16, 24, 36, and 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points. |
| Arm/Group Title | Augment® Injectable Bone Graft | Autologous Bone Graft |
|---|---|---|
| Arm/Group Description | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) | Standard Rigid Fixation + Autologous bone graft |
| Measure Participants | 132 | 167 |
| Baseline |
51.4
(2.4)
|
50.4
(2.1)
|
| Week 9 |
20.5
(2.1)
|
15.4
(1.8)
|
| Week 12 |
18.9
(2.1)
|
17.8
(1.8)
|
| Week 16 |
21.7
(2.2)
|
18.9
(2.0)
|
| Week 24 |
20.9
(2.2)
|
15.3
(1.9)
|
| Week 36 |
17.4
(2.1)
|
12.4
(1.8)
|
| Week 52 |
15.8
(2.2)
|
12.6
(1.9)
|
| Title | SF-12 Physical Component Score |
|---|---|
| Description | The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life. |
| Time Frame | Baseline, 9, 12, 16, 24, 36, and 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis conducted on patients at Baseline, 12, 16, 24, 36, and 52 weeks time points. |
| Arm/Group Title | Augment® Injectable Bone Graft | Autologous Bone Graft |
|---|---|---|
| Arm/Group Description | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) | Standard Rigid Fixation + Autologous bone graft |
| Measure Participants | 132 | 167 |
| Baseline |
30.8
(0.8)
|
30.8
(0.7)
|
| Week 12 |
36.9
(0.8)
|
36.3
(0.7)
|
| Week 16 |
37.9
(0.8)
|
39.0
(0.7)
|
| Week 24 |
40.3
(0.9)
|
42.2
(0.7)
|
| Week 36 |
42.1
(0.9)
|
44.5
(0.8)
|
| Week 52 |
42.9
(0.9)
|
45.5
(0.8)
|
Adverse Events
| Time Frame | Patients were assessed through study completion scheduled at 52 weeks following surgery. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Augment® Injectable Bone Graft | Autologous Bone Graft | ||
| Arm/Group Description | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) | Standard Rigid Fixation + Autologous bone graft | ||
All Cause Mortality |
||||
| Augment® Injectable Bone Graft | Autologous Bone Graft | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/132 (0%) | 0/167 (0%) | ||
Serious Adverse Events |
||||
| Augment® Injectable Bone Graft | Autologous Bone Graft | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/132 (15.2%) | 35/167 (21%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/132 (0.8%) | 0/167 (0%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/132 (0%) | 1/167 (0.6%) | ||
| Arrhythmia | 1/132 (0.8%) | 0/167 (0%) | ||
| Atrial fibrillation | 0/132 (0%) | 1/167 (0.6%) | ||
| Atrioventricular block complete | 0/132 (0%) | 1/167 (0.6%) | ||
| Cardiac failure congestive | 0/132 (0%) | 1/167 (0.6%) | ||
| Myocardial infarction | 0/132 (0%) | 1/167 (0.6%) | ||
| Congenital, familial and genetic disorders | ||||
| Congenital foot malformation | 0/132 (0%) | 1/167 (0.6%) | ||
| Gastrointestinal disorders | ||||
| gastrointestinal hemorrhage | 0/132 (0%) | 2/167 (1.2%) | ||
| Megacolon | 0/132 (0%) | 1/167 (0.6%) | ||
| General disorders | ||||
| Impaired healing | 1/132 (0.8%) | 0/167 (0%) | ||
| Hepatobiliary disorders | ||||
| Gallbladder pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 1/132 (0.8%) | 0/167 (0%) | ||
| Infections and infestations | ||||
| Clostridium difficile colitis | 0/132 (0%) | 1/167 (0.6%) | ||
| Infection | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Osteomyelitis | 0/132 (0%) | 1/167 (0.6%) | ||
| Pneumonia | 1/132 (0.8%) | 0/167 (0%) | ||
| Postoperative wound infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Staphylococcal infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Urinary tract infection | 1/132 (0.8%) | 0/167 (0%) | ||
| Wound infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Injury, poisoning and procedural complications | ||||
| Device related infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Overdose | 0/132 (0%) | 1/167 (0.6%) | ||
| Wound infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/132 (0.8%) | 0/167 (0%) | ||
| Osteoarthritis | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Osteoporosis | 0/132 (0%) | 1/167 (0.6%) | ||
| Pain in extremity | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Endometrial cancer | 0/132 (0%) | 1/167 (0.6%) | ||
| Renal cell carcinoma stage unspecified | 0/132 (0%) | 1/167 (0.6%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Pregnancy | 0/132 (0%) | 1/167 (0.6%) | ||
| Psychiatric disorders | ||||
| Alcohol withdrawal syndrome | 0/132 (0%) | 1/167 (0.6%) | ||
| Suicidal ideation | 1/132 (0.8%) | 0/167 (0%) | ||
| Renal and urinary disorders | ||||
| Ureteric injury | 0/132 (0%) | 1/167 (0.6%) | ||
| Urinary tract infection | 1/132 (0.8%) | 0/167 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 0/132 (0%) | 2/167 (1.2%) | ||
| Pneumonia | 1/132 (0.8%) | 0/167 (0%) | ||
| Pulmonary embolism | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Cellulitis | 1/132 (0.8%) | 0/167 (0%) | ||
| Vascular disorders | ||||
| Aneurysm | 1/132 (0.8%) | 0/167 (0%) | ||
| Aortic stenosis | 0/132 (0%) | 2/167 (1.2%) | ||
| Deep vein thrombosis | 2/132 (1.5%) | 3/167 (1.8%) | ||
| Hematoma | 1/132 (0.8%) | 0/167 (0%) | ||
| Pulmonary embolism | 0/132 (0%) | 1/167 (0.6%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Augment® Injectable Bone Graft | Autologous Bone Graft | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 116/132 (87.9%) | 135/167 (80.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/132 (0.8%) | 2/167 (1.2%) | ||
| Myelodysplastic syndrome | 1/132 (0.8%) | 0/167 (0%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/132 (0%) | 1/167 (0.6%) | ||
| Arrhythmia | 4/132 (3%) | 0/167 (0%) | ||
| Arrhythmia supraventricular | 0/132 (0%) | 1/167 (0.6%) | ||
| Atrial fibrillation | 2/132 (1.5%) | 2/167 (1.2%) | ||
| Atrioventricular block complete | 0/132 (0%) | 1/167 (0.6%) | ||
| Bradycardia | 0/132 (0%) | 1/167 (0.6%) | ||
| Cardiac failure congestive | 0/132 (0%) | 1/167 (0.6%) | ||
| Chest discomfort | 1/132 (0.8%) | 0/167 (0%) | ||
| Myocardial infarction | 0/132 (0%) | 1/167 (0.6%) | ||
| Syncope | 1/132 (0.8%) | 0/167 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Congenital foot malformation | 0/132 (0%) | 1/167 (0.6%) | ||
| Talipes | 0/132 (0%) | 1/167 (0.6%) | ||
| Ear and labyrinth disorders | ||||
| Labyrinthitis | 1/132 (0.8%) | 0/167 (0%) | ||
| Otitis media | 0/132 (0%) | 1/167 (0.6%) | ||
| Vertigo | 3/132 (2.3%) | 1/167 (0.6%) | ||
| Endocrine disorders | ||||
| Diabetes mellitus | 1/132 (0.8%) | 0/167 (0%) | ||
| Diabetic neuropathy | 1/132 (0.8%) | 0/167 (0%) | ||
| Hypothyroidism | 2/132 (1.5%) | 0/167 (0%) | ||
| Eye disorders | ||||
| Cataract | 0/132 (0%) | 1/167 (0.6%) | ||
| Chalazion | 1/132 (0.8%) | 0/167 (0%) | ||
| Eye pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Optic disc disorder | 0/132 (0%) | 1/167 (0.6%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 20/132 (15.2%) | 12/167 (7.2%) | ||
| Abdominal pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Constipation | 5/132 (3.8%) | 4/167 (2.4%) | ||
| Diarrhea | 1/132 (0.8%) | 2/167 (1.2%) | ||
| Dyspepsia | 1/132 (0.8%) | 0/167 (0%) | ||
| Flatulence | 1/132 (0.8%) | 0/167 (0%) | ||
| Gastric ulcer | 1/132 (0.8%) | 0/167 (0%) | ||
| Gastric ulcer haemorrhage | 1/132 (0.8%) | 0/167 (0%) | ||
| Gastroenteritis | 0/132 (0%) | 1/167 (0.6%) | ||
| Gastrointestinal haemorrhage | 0/132 (0%) | 2/167 (1.2%) | ||
| Gastroesophageal reflux disease | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Hiatus hernia | 1/132 (0.8%) | 0/167 (0%) | ||
| Megacolon | 0/132 (0%) | 1/167 (0.6%) | ||
| Mouth ulceration | 0/132 (0%) | 1/167 (0.6%) | ||
| Procedural nausea | 0/132 (0%) | 1/167 (0.6%) | ||
| Tooth infection | 1/132 (0.8%) | 0/167 (0%) | ||
| Toothache | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Vomiting | 4/132 (3%) | 8/167 (4.8%) | ||
| General disorders | ||||
| Feeling Hot | 16/132 (12.1%) | 6/167 (3.6%) | ||
| Local Swelling | 27/132 (20.5%) | 13/167 (7.8%) | ||
| Medical Device Discomfort | 7/132 (5.3%) | 3/167 (1.8%) | ||
| Pyrexia | 7/132 (5.3%) | 2/167 (1.2%) | ||
| Tenderness | 22/132 (16.7%) | 8/167 (4.8%) | ||
| Administration site pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Chills | 4/132 (3%) | 1/167 (0.6%) | ||
| Drug withdrawal syndrome | 0/132 (0%) | 1/167 (0.6%) | ||
| Impaired healing | 6/132 (4.5%) | 5/167 (3%) | ||
| Inflammation | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Necrosis | 1/132 (0.8%) | 0/167 (0%) | ||
| Non-cardiac chest pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Oedema | 0/132 (0%) | 2/167 (1.2%) | ||
| Oedema peripheral | 1/132 (0.8%) | 6/167 (3.6%) | ||
| Pain | 2/132 (1.5%) | 1/167 (0.6%) | ||
| Soft tissue inflammation | 0/132 (0%) | 1/167 (0.6%) | ||
| Swelling | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Ulcer | 0/132 (0%) | 1/167 (0.6%) | ||
| Hepatobiliary disorders | ||||
| Gallbladder pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Immune system disorders | ||||
| Drug hypersensitivity | 0/132 (0%) | 1/167 (0.6%) | ||
| Hypersensitivity | 1/132 (0.8%) | 0/167 (0%) | ||
| Infections and infestations | ||||
| Bronchitis | 1/132 (0.8%) | 5/167 (3%) | ||
| Cellulitis | 2/132 (1.5%) | 3/167 (1.8%) | ||
| Clostridium difficile colitis | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Cystitis | 0/132 (0%) | 1/167 (0.6%) | ||
| Ear infection | 1/132 (0.8%) | 0/167 (0%) | ||
| Fungal skin infection | 1/132 (0.8%) | 0/167 (0%) | ||
| Herpes zoster | 1/132 (0.8%) | 0/167 (0%) | ||
| Infected skin ulcer | 0/132 (0%) | 1/167 (0.6%) | ||
| Infection | 4/132 (3%) | 3/167 (1.8%) | ||
| Influenza | 1/132 (0.8%) | 2/167 (1.2%) | ||
| Kidney infection | 0/132 (0%) | 2/167 (1.2%) | ||
| Localised infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Lower respiratory tract infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Nasopharyngitis | 3/132 (2.3%) | 6/167 (3.6%) | ||
| Onychomycosis | 1/132 (0.8%) | 0/167 (0%) | ||
| Osteomyelitis | 0/132 (0%) | 1/167 (0.6%) | ||
| Pharyngitis streptococcal | 0/132 (0%) | 2/167 (1.2%) | ||
| Pneumonia | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Postoperative wound infection | 0/132 (0%) | 5/167 (3%) | ||
| Respiratory tract infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Sinusitis | 3/132 (2.3%) | 2/167 (1.2%) | ||
| Staphylococcal infection | 3/132 (2.3%) | 2/167 (1.2%) | ||
| Tooth abscess | 2/132 (1.5%) | 0/167 (0%) | ||
| Upper respiratory tract infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Urinary tract infection | 3/132 (2.3%) | 2/167 (1.2%) | ||
| Viral labyrinthitis | 0/132 (0%) | 1/167 (0.6%) | ||
| Wound infection | 1/132 (0.8%) | 2/167 (1.2%) | ||
| Injury, poisoning and procedural complications | ||||
| Arteriovenous graft site haematoma | 0/132 (0%) | 1/167 (0.6%) | ||
| Avulsion fracture | 0/132 (0%) | 1/167 (0.6%) | ||
| Blister | 0/132 (0%) | 1/167 (0.6%) | ||
| Burns second degree | 0/132 (0%) | 1/167 (0.6%) | ||
| Burns third degree | 0/132 (0%) | 1/167 (0.6%) | ||
| Bursa injury | 0/132 (0%) | 1/167 (0.6%) | ||
| Cartilage injury | 0/132 (0%) | 1/167 (0.6%) | ||
| Contusion | 4/132 (3%) | 3/167 (1.8%) | ||
| Corneal abrasion | 1/132 (0.8%) | 0/167 (0%) | ||
| Device related infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Eschar | 1/132 (0.8%) | 0/167 (0%) | ||
| Fall | 5/132 (3.8%) | 5/167 (3%) | ||
| Fibula fracture | 0/132 (0%) | 1/167 (0.6%) | ||
| Fracture | 0/132 (0%) | 2/167 (1.2%) | ||
| Graft complication | 0/132 (0%) | 8/167 (4.8%) | ||
| Graft infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Incision site complication | 1/132 (0.8%) | 0/167 (0%) | ||
| Joint dislocation | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Joint injury | 0/132 (0%) | 1/167 (0.6%) | ||
| Joint sprain | 0/132 (0%) | 3/167 (1.8%) | ||
| Limb injury | 0/132 (0%) | 2/167 (1.2%) | ||
| Medical device complication | 3/132 (2.3%) | 3/167 (1.8%) | ||
| Medical device pain | 0/132 (0%) | 6/167 (3.6%) | ||
| Medical device site reaction | 0/132 (0%) | 1/167 (0.6%) | ||
| Meniscus lesion | 1/132 (0.8%) | 0/167 (0%) | ||
| Necrotic preservation injury of graft | 1/132 (0.8%) | 0/167 (0%) | ||
| Nerve compression | 0/132 (0%) | 1/167 (0.6%) | ||
| Open wound | 1/132 (0.8%) | 0/167 (0%) | ||
| Overdose | 0/132 (0%) | 2/167 (1.2%) | ||
| Peroneal nerve injury | 1/132 (0.8%) | 0/167 (0%) | ||
| Post procedural cellulitis | 0/132 (0%) | 1/167 (0.6%) | ||
| Post procedural complication | 0/132 (0%) | 1/167 (0.6%) | ||
| Post procedural oedema | 0/132 (0%) | 1/167 (0.6%) | ||
| Postoperative wound infection | 1/132 (0.8%) | 0/167 (0%) | ||
| Procedural pain | 0/132 (0%) | 2/167 (1.2%) | ||
| Skin laceration | 1/132 (0.8%) | 2/167 (1.2%) | ||
| Spinal compression fracture | 0/132 (0%) | 1/167 (0.6%) | ||
| Stress fracture | 2/132 (1.5%) | 2/167 (1.2%) | ||
| Superficial injury of eye | 1/132 (0.8%) | 0/167 (0%) | ||
| Tooth fracture | 1/132 (0.8%) | 0/167 (0%) | ||
| Wound complication | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Wound decomposition | 1/132 (0.8%) | 0/167 (0%) | ||
| Wound dehiscence | 5/132 (3.8%) | 2/167 (1.2%) | ||
| Wound infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Investigations | ||||
| Blood cholesterol increased | 0/132 (0%) | 2/167 (1.2%) | ||
| Blood creatinine increased | 1/132 (0.8%) | 0/167 (0%) | ||
| Blood urea increased | 1/132 (0.8%) | 0/167 (0%) | ||
| Oxygen saturation decreased | 0/132 (0%) | 1/167 (0.6%) | ||
| Respiratory rate decreased | 0/132 (0%) | 1/167 (0.6%) | ||
| Urine analysis | 1/132 (0.8%) | 0/167 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 1/132 (0.8%) | 0/167 (0%) | ||
| Gout | 1/132 (0.8%) | 0/167 (0%) | ||
| Hypercholesterolaemia | 1/132 (0.8%) | 0/167 (0%) | ||
| Hypokalaemia | 1/132 (0.8%) | 0/167 (0%) | ||
| Hypothyroidism | 0/132 (0%) | 1/167 (0.6%) | ||
| Iron deficiency | 0/132 (0%) | 1/167 (0.6%) | ||
| Oedema | 1/132 (0.8%) | 0/167 (0%) | ||
| Oedema peripheral | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 28/132 (21.2%) | 19/167 (11.4%) | ||
| Back Pain | 9/132 (6.8%) | 7/167 (4.2%) | ||
| Joint range of motion decreased | 7/132 (5.3%) | 1/167 (0.6%) | ||
| Pain in extremity | 44/132 (33.3%) | 35/167 (21%) | ||
| Arthritis | 2/132 (1.5%) | 1/167 (0.6%) | ||
| Arthritis infective | 0/132 (0%) | 1/167 (0.6%) | ||
| Bone cyst | 1/132 (0.8%) | 0/167 (0%) | ||
| Bone pain | 0/132 (0%) | 1/167 (0.6%) | ||
| Bunion | 1/132 (0.8%) | 0/167 (0%) | ||
| Exostosis | 1/132 (0.8%) | 0/167 (0%) | ||
| Flank pain | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Foot deformity | 0/132 (0%) | 2/167 (1.2%) | ||
| Gout | 0/132 (0%) | 3/167 (1.8%) | ||
| Intervertebral disc protrusion | 1/132 (0.8%) | 0/167 (0%) | ||
| Joint contracture | 1/132 (0.8%) | 0/167 (0%) | ||
| Joint crepitation | 0/132 (0%) | 1/167 (0.6%) | ||
| Joint destruction | 2/132 (1.5%) | 0/167 (0%) | ||
| Joint dislocation | 0/132 (0%) | 1/167 (0.6%) | ||
| Joint instability | 1/132 (0.8%) | 0/167 (0%) | ||
| Joint sprain | 0/132 (0%) | 1/167 (0.6%) | ||
| Joint swelling | 3/132 (2.3%) | 2/167 (1.2%) | ||
| Monarthritis | 2/132 (1.5%) | 1/167 (0.6%) | ||
| Muscle spasms | 3/132 (2.3%) | 5/167 (3%) | ||
| Muscle tightness | 1/132 (0.8%) | 0/167 (0%) | ||
| Musculoskeletal pain | 2/132 (1.5%) | 5/167 (3%) | ||
| Myalgia | 2/132 (1.5%) | 0/167 (0%) | ||
| Neck pain | 0/132 (0%) | 2/167 (1.2%) | ||
| Osteoarthritis | 4/132 (3%) | 3/167 (1.8%) | ||
| Osteopenia | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Osteoporosis | 0/132 (0%) | 1/167 (0.6%) | ||
| Plantar fasciitis | 0/132 (0%) | 3/167 (1.8%) | ||
| Rotator cuff syndrome | 0/132 (0%) | 3/167 (1.8%) | ||
| Synovial cyst | 2/132 (1.5%) | 0/167 (0%) | ||
| Synovitis | 0/132 (0%) | 1/167 (0.6%) | ||
| Tendon pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Tendonitis | 1/132 (0.8%) | 2/167 (1.2%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Bone cyst | 1/132 (0.8%) | 0/167 (0%) | ||
| Endometrial cancer | 0/132 (0%) | 1/167 (0.6%) | ||
| Renal cell carcinoma stage unspecified | 0/132 (0%) | 1/167 (0.6%) | ||
| Tumour pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Nervous system disorders | ||||
| Headache | 7/132 (5.3%) | 2/167 (1.2%) | ||
| Hypoaesthesia | 10/132 (7.6%) | 10/167 (6%) | ||
| Carpal tunnel syndrome | 1/132 (0.8%) | 0/167 (0%) | ||
| Complex regional pain syndrome | 1/132 (0.8%) | 0/167 (0%) | ||
| Dizziness | 5/132 (3.8%) | 0/167 (0%) | ||
| Hyperpathia | 1/132 (0.8%) | 0/167 (0%) | ||
| Insomnia | 3/132 (2.3%) | 3/167 (1.8%) | ||
| Neuralgia | 2/132 (1.5%) | 3/167 (1.8%) | ||
| Neuritis | 0/132 (0%) | 1/167 (0.6%) | ||
| Neuropathy peripheral | 2/132 (1.5%) | 6/167 (3.6%) | ||
| Paraesthesia | 2/132 (1.5%) | 1/167 (0.6%) | ||
| Peroneal nerve injury | 0/132 (0%) | 1/167 (0.6%) | ||
| Sensory loss | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Sinus headache | 1/132 (0.8%) | 0/167 (0%) | ||
| Tarsal tunnel syndrome | 1/132 (0.8%) | 0/167 (0%) | ||
| Tension headache | 1/132 (0.8%) | 0/167 (0%) | ||
| Tremor | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Urinary incontinence | 1/132 (0.8%) | 0/167 (0%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Pregnancy | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Vomiting in pregnancy | 0/132 (0%) | 1/167 (0.6%) | ||
| Psychiatric disorders | ||||
| Alcohol withdrawal syndrome | 0/132 (0%) | 1/167 (0.6%) | ||
| Anxiety | 0/132 (0%) | 2/167 (1.2%) | ||
| Depression | 5/132 (3.8%) | 2/167 (1.2%) | ||
| Insomnia | 1/132 (0.8%) | 0/167 (0%) | ||
| Mood altered | 0/132 (0%) | 1/167 (0.6%) | ||
| Suicidal ideation | 1/132 (0.8%) | 0/167 (0%) | ||
| Renal and urinary disorders | ||||
| Bladder spasm | 0/132 (0%) | 1/167 (0.6%) | ||
| Dysuria | 1/132 (0.8%) | 0/167 (0%) | ||
| Incontinence | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Micturition urgency | 0/132 (0%) | 1/167 (0.6%) | ||
| Nephrolithiasis | 0/132 (0%) | 1/167 (0.6%) | ||
| Renal colic | 0/132 (0%) | 1/167 (0.6%) | ||
| Renal failure acute | 0/132 (0%) | 2/167 (1.2%) | ||
| Ureteric injury | 0/132 (0%) | 1/167 (0.6%) | ||
| Ureteric stenosis | 1/132 (0.8%) | 0/167 (0%) | ||
| Urinary incontinence | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Urinary retention | 2/132 (1.5%) | 4/167 (2.4%) | ||
| Urinary tract infection | 2/132 (1.5%) | 1/167 (0.6%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Prostatitis | 2/132 (1.5%) | 0/167 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Apnoea | 2/132 (1.5%) | 0/167 (0%) | ||
| Asthma | 0/132 (0%) | 2/167 (1.2%) | ||
| Chronic obstructive pulmonary disease | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Cough | 2/132 (1.5%) | 1/167 (0.6%) | ||
| Dyspnoea | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Hypoxia | 0/132 (0%) | 1/167 (0.6%) | ||
| Nasopharyngitis | 0/132 (0%) | 1/167 (0.6%) | ||
| Oropharyngeal pain | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Pharyngolaryngeal pain | 0/132 (0%) | 1/167 (0.6%) | ||
| Pneumonia | 1/132 (0.8%) | 0/167 (0%) | ||
| Pulmonary embolism | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Pulmonary oedema | 0/132 (0%) | 1/167 (0.6%) | ||
| Respiratory tract infection | 0/132 (0%) | 1/167 (0.6%) | ||
| Sinus congestion | 0/132 (0%) | 1/167 (0.6%) | ||
| Sinusitis | 1/132 (0.8%) | 0/167 (0%) | ||
| Wheezing | 0/132 (0%) | 1/167 (0.6%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Application site vesicles | 0/132 (0%) | 1/167 (0.6%) | ||
| Blister | 6/132 (4.5%) | 3/167 (1.8%) | ||
| Blood blister | 0/132 (0%) | 1/167 (0.6%) | ||
| Cellulitis | 2/132 (1.5%) | 2/167 (1.2%) | ||
| Dermatitis contact | 0/132 (0%) | 1/167 (0.6%) | ||
| Erythema | 5/132 (3.8%) | 2/167 (1.2%) | ||
| Eschar | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Excessive granulation tissue | 1/132 (0.8%) | 0/167 (0%) | ||
| Excoriation | 0/132 (0%) | 1/167 (0.6%) | ||
| Hypoaesthesia facial | 1/132 (0.8%) | 0/167 (0%) | ||
| Onychomycosis | 0/132 (0%) | 1/167 (0.6%) | ||
| Pruritus | 5/132 (3.8%) | 5/167 (3%) | ||
| Pruritus generalised | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Rash | 5/132 (3.8%) | 4/167 (2.4%) | ||
| Rash generalised | 0/132 (0%) | 1/167 (0.6%) | ||
| Scar pain | 1/132 (0.8%) | 0/167 (0%) | ||
| Seborrhoeic keratosis | 0/132 (0%) | 1/167 (0.6%) | ||
| Skin disorder | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Skin irritation | 1/132 (0.8%) | 1/167 (0.6%) | ||
| Skin ulcer | 2/132 (1.5%) | 0/167 (0%) | ||
| Splinter haemorrhages | 1/132 (0.8%) | 0/167 (0%) | ||
| Surgical and medical procedures | ||||
| Bladder neoplasm surgery | 0/132 (0%) | 1/167 (0.6%) | ||
| Cast application | 0/132 (0%) | 1/167 (0.6%) | ||
| Endodontic procedure | 2/132 (1.5%) | 0/167 (0%) | ||
| Gastric banding | 0/132 (0%) | 1/167 (0.6%) | ||
| Incisional drainage | 0/132 (0%) | 1/167 (0.6%) | ||
| Mole excision | 0/132 (0%) | 1/167 (0.6%) | ||
| Splint application | 1/132 (0.8%) | 0/167 (0%) | ||
| Ureteral stent removal | 0/132 (0%) | 1/167 (0.6%) | ||
| Wound drainage | 3/132 (2.3%) | 2/167 (1.2%) | ||
| Vascular disorders | ||||
| Aneurysm | 1/132 (0.8%) | 0/167 (0%) | ||
| Aortic arteriosclerosis | 1/132 (0.8%) | 0/167 (0%) | ||
| Aortic stenosis | 0/132 (0%) | 2/167 (1.2%) | ||
| Deep vein thrombosis | 3/132 (2.3%) | 4/167 (2.4%) | ||
| Haematoma | 2/132 (1.5%) | 1/167 (0.6%) | ||
| Haemorrhage | 0/132 (0%) | 1/167 (0.6%) | ||
| Hypertension | 1/132 (0.8%) | 2/167 (1.2%) | ||
| Hypotension | 1/132 (0.8%) | 2/167 (1.2%) | ||
| Procedural hypertension | 0/132 (0%) | 1/167 (0.6%) | ||
| Pulmonary embolism | 0/132 (0%) | 1/167 (0.6%) | ||
| Rectal haemorrhage | 1/132 (0.8%) | 0/167 (0%) | ||
| Varicose vein | 0/132 (0%) | 1/167 (0.6%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Justin Moss |
|---|---|
| Organization | Wright Medical |
| Phone | 615-236-4984 |
| Justin.Moss@wright.com |
- BMTI-2010-01
- NCT01008891