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| Name | Class |
|---|---|
| DePuy Spine | INDUSTRY |
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEALOS and Leopard Cage | Device | Placement in interbody space |
| |
| Leopard Cage and Autograft |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) | Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties). | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72205 | United States | |||
220 subjects were screened and 82 were excluded (59 did not meet criteria and 23 refused participation).Use of non-steroidal anti-inflammatory medications or cyclooxygenase-II (COX-2) inhibitors (a non-steroidal anti-inflammatory drug that directly targets COX-2, an enzyme responsible for inflammation and pain) at time of surgery were exclusionary.
Subjects were enrolled from 3Apr06 to 31Dec07. Subjects were seen at medical clinics/hospitals, usually by their regular doctor and not found through ads. Subjects were asked to enroll if they were having back surgery for back pain. Enrollment was stopped for administrative reasons at 138 subjects; the per protocol plan was at least 350 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | HEALOS | HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae. The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
Placement in the interbody space |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| Brandon | Florida | 33511 | United States |
| Jacksonville | Florida | 32204 | United States |
| Savannah | Georgia | 31405 | United States |
| Chicago | Illinois | 60611 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Annapolis | Maryland | 21401 | United States |
| Billings | Montana | 59101 | United States |
| Williamsville | New York | 14221 | United States |
| Norwood | Ohio | 45212 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Eugene | Oregon | 97401 | United States |
| Temple | Texas | 76508 | United States |
| Salt Lake City | Utah | 84108 | United States |
| Spokane | Washington | 99218 | United States |
| Milwaukee | Wisconsin | 53233 | United States |
| FG001 | Control | Autograft is bone taken from the subject's own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HEALOS | HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae. The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested. |
| BG001 | Control | Autograft is bone taken from the subject's own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Between 18-70 years old | Mean | Full Range | Years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) | Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties). | Safety Population:All subjects treated. Full Analysis Set(FAS):Subset of Safety Pop. w/follow up. All effectiveness measures were to be assessed on FAS. FAS is intent-to-treat pop. Per Protocol: Subset of FAS who complete study, treated as randomized w/no major protocol deviations. All analyses were to be on this subset. | Posted | Number | Subjects | 24 months |
|
|
|
4 years and 7 months
Regular assessments made via study visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HEALOS | HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae. The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested. | 23 | 92 | 77 | 92 | ||
| EG001 | Control | Autograft is bone taken from the subject's own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft. | 13 | 46 | 43 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Spondylolisthesis | Congenital, familial and genetic disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment | Hospitalization |
|
| Ileus | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment | Hospitalization |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment | 2 hospitalizations for the same patient |
|
| Implant Site Pain | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment | Hospitalization |
|
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Wound Secretion | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment | Hospitalization after a fall |
|
| Fracture Nonunion | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment | Hospitalization x4 |
|
| Intervertebral Discitis | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment | Hospitalization x6 |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment | Hospitalization x2 |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment |
| |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | Systematic Assessment |
| |
| Cervicobrachial Syndrome | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment | Hospitalization |
|
| Myelopathy | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA version 8.1 | Systematic Assessment |
| |
| Conversion Disorder | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Cystocele | Renal and urinary disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 8.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment | Does not meet the criteria for seriousness |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment | Does not meet the criteria for seriousness |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 8.1 | Systematic Assessment | Does not meet the criteria for seriousness |
|
| Asthenia | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 8.1 | Systematic Assessment | Does not meet criteria for seriousness |
|
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Back Injury | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Post Laminectomy Syndrome | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment | Does not meet criteria for seriousness |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Buttock Pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment | Does not meet criteria for seriousness |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment | Does not meet criteria for seriousness |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | Systematic Assessment | Does not meet criteria for seriousness |
|
| Cervicobrachial Syndrome | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment | Does not meet criteria for seriousness |
|
| Headache | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Hyporeflexia | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Sensory Loss | Nervous system disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | Systematic Assessment |
|
Stringent criteria for endpoint.Minimum sample size not reached; no hypothesis testing.High portion of current/prior smokers in both groups may impact fusion success.Product usage was appropriate and not low.This study is not on label for HEALOS.
The PI cannot publish the results without consent of Sponsor. The results must be given to Sponsor 60 days prior to use. This review is not meant to curtail distribution of data, but to identify confidential material and/or to review the content for conformance to regulations. The Sponsor has the right to edit materials to preserve confidentiality of proprietary information. If requested, the Institution and PI will withhold publication for 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manny Lazaro, Director, Clinical Affairs | Advanced Technologies and Regenerative Medicine, LLC | 508-828-2741 | mlazaro@its.jnj.com |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Male |
|