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The purpose of this study is to learn whether an investigational device called the Activ-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine.
The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control (the Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes Spine]) with respect to the rate of individual subject success at 24 months. Individual subject success is a composite of effectiveness and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational | Experimental | Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. |
|
| Control | Active Comparator | Implantation of either the ProDisc-L Total Disc Replacement or Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activ-L Artificial Disc | Device | Implantation at one level of the lumbar spine, either L4/L5 or L5/S1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Success at 24 Months Relative to Baseline | Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score. | 24 months |
| Device Success | Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months. | 24 months |
| Absence of Serious Device Related Adverse Events | Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC) | 24 months |
| Range of Motion (ROM) Success | Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline | 24 months |
| Neurological Success | Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline | 24 months |
| ODI Success | Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Success for Back and Leg Pain at Rest | Number of patients demonstrating improvement in back and leg pain at 24 months compared to baseline | 24 months |
| ODI Success Using Two Measures of Success |
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Inclusion Criteria:
Age 18 - 60, skeletally mature
Symptomatic DDD with objective evidence of lumbar DDD, with any of the following characteristics by MRI scan:
Single level symptomatic disease at L4/L5 or L5/S1.
ODI score ≥ 40/100.
Surgical candidate for an anterior approach to the lumbar spine.
Back pain at the operative level only, with or without leg pain.
Back pain VAS score greater than the higher of the two VAS leg pain scores.
VAS back pain score ≥ 40/100 mm.
Willing to return for follow-up visits and sign an Informed Consent and HIPAA Authorization.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolando Garcia, M.D. | Orthopedic Care Center | Principal Investigator |
| James J Yue, M.D. | Yale University | Principal Investigator |
| Dom Coric, M.D. | Carolina Neurosurgery and Spine Associates | Principal Investigator |
| Steven Dennis, M.D. | Hoag Memorial Hospital Presbyterian | Principal Investigator |
| Federico P. Girardi, M.D. | Hospital for Special Surgery, New York | Principal Investigator |
| Mick Perez-Cruet, M.D. | Michigan Head and Spine Institute | Principal Investigator |
| Harel Deutsch, M.D. | Rush University Medical Center | Principal Investigator |
| Glenn Buttermann, M.D. | Midwest Spine Institute | Principal Investigator |
| Dzung Dinh, M.D. | Neuroscience Education and Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Memorial Hospital La Jolla | La Jolla | California | 92037 | United States | ||
| Hoag Memorial Hospital Presbyterian |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20380708 | Derived | Yue JJ, Mo FF. Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L artificial disc in the treatment of degenerative disc disease. BMC Surg. 2010 Apr 9;10:14. doi: 10.1186/1471-2482-10-14. |
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Subjects were screened and enrolled at 19 US health care center sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational | Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1 |
| FG001 | Control | Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ProDisc-L Total Disc Replacement or Charité Artificial Disc | Device | Implantation at one level of the lumbar spine, either L4/L5 or L5/S1. |
|
Number of subjects demonstrating improvement in two measures of ODI success at 24 months compared to baseline
| 24 months |
| Improvement in SF-36 Scores | Number of subjects demonstrating a greater than or equal to 15% improvement in mental (MCS) and physical (PCS) component summary scores at 24 months compared to baseline | 24 months |
| Vikas Patel, M.D. |
| University of Colorado, Denver |
| Principal Investigator |
| Christopher Ames, M.D. | University of California, San Francisco | Principal Investigator |
| John Regan, M.D. | St. John's Hospital and Health Center | Principal Investigator |
| Andrew Dailey, M.D. | University of Utah Medical Center | Principal Investigator |
| Darren Bergey, M.D. | Rancho Specialty Hospital | Principal Investigator |
| Brian Dalton, M.D. | Hamot Medical Center | Principal Investigator |
| Scott Leary, M.D. | Scripps Memorial Hospital La Jolla | Principal Investigator |
| David Hart, M.D. | University Hospitals Cleveland | Principal Investigator |
| Antonio Castellvi, M.D. | Foundatin for Orthopaedic Research and Education | Principal Investigator |
| Newport Beach |
| California |
| 92658 |
| United States |
| Rancho Specialty Hospital | Rancho Cucamonga | California | 91730 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| St. John's Hospital and Health Center | Santa Monica | California | 90404 | United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Yale University School of Medicine/New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Aventura Hospital and Medical Center | Aventura | Florida | 33180 | United States |
| University Community Hospital | Tampa | Florida | 33613 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Neurosciences Education and Research Foundation | Peoria | Illinois | 61605 | United States |
| HealthEast St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Carolinas Healthcare | Charlotte | North Carolina | 28203 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Hamot Medical Center | Erie | Pennsylvania | 16507 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Baseline |
|
| 24 Months |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational | Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1 |
| BG001 | Control | Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. |
| 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, Categorical | All enrolled subjects | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | All enrolled subjects | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | All enrolled subjects | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | All enrolled subjects | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | All enrolled subjects | Count of Participants | Participants |
| |||||||||||||||||
| Oswestry Disability Index (ODI) Scores for Low Back Pain | Scores on a scale from 0 (minimal disability) to 100 (bed-bound) | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Visual Analog Scale (VAS) Ratings for Back and Leg Pain | Ratings on a scale from 0 (no pain) to 100 (worst possible pain) | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Short-Form (36) Health Questionnaire (SF-36) Scores | Scores on a scale from 0 (maximum disability) to 100 (no disability) for mental component summary (MCS) and physical component summary (PCS) | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Rotational Range of Motion | Mean | Standard Deviation | degrees |
| |||||||||||||||||
| Translational Range of Motion | Mean | Standard Deviation | millimeters |
| |||||||||||||||||
| Normal Neurological Status | Number of subjects meeting the following criteria for normal status: Motor - Grade 5 (active movement vs. full resistance); Sensory - Grade 2 (normal); Reflexes - Grade 2 (normal) | Number | 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 | Overall Success at 24 Months Relative to Baseline | Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score. | Intent to treat population; missing data imputed as failures | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VAS Success for Back and Leg Pain at Rest | Number of patients demonstrating improvement in back and leg pain at 24 months compared to baseline | Intent to treat population; observed data (i.e. missing data not imputed as failures) | Posted | Number | participants | 24 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Device Success | Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months. | Intent to treat population; missing data imputed as failures | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Absence of Serious Device Related Adverse Events | Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC) | Intent to treat population; missing data imputed as failures | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Range of Motion (ROM) Success | Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline | Intent to treat population; missing data imputed as failures | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Neurological Success | Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline | Intent to treat population; missing data imputed as failures | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | ODI Success | Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline | Intent to treat population; missing data imputed as failures | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ODI Success Using Two Measures of Success | Number of subjects demonstrating improvement in two measures of ODI success at 24 months compared to baseline | Intent to treat population; observational data (i.e. missing data not imputed as failures) | Posted | Number | participants | 24 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement in SF-36 Scores | Number of subjects demonstrating a greater than or equal to 15% improvement in mental (MCS) and physical (PCS) component summary scores at 24 months compared to baseline | Intent to treat population; observational data (i.e. missing data not imputed as failures) | Posted | Number | participants | 24 months |
|
|
Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
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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 | Investigational | Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1 | 86 | 218 | 197 | 218 | ||
| EG001 | Control | Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. | 57 | 106 | 100 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Custom | Systematic Assessment |
| |
| High Cholesterol | Blood and lymphatic system disorders | Custom | Systematic Assessment |
| |
| Cardiac Issues | Cardiac disorders | Custom | Systematic Assessment | Includes arrhythmia, chest pain, heart disease and myocardial infarct |
|
| Eyes, Ears, Nose or Throat Issues | Ear and labyrinth disorders | Custom | Systematic Assessment |
| |
| Diabetes Mellitus | Endocrine disorders | Custom | Systematic Assessment |
| |
| Goiter | Endocrine disorders | Custom | Systematic Assessment |
| |
| Esophageal Issues | Gastrointestinal disorders | Custom | Systematic Assessment | Includes esophageal bleeding and esophagitis |
|
| Gastric Issues | Gastrointestinal disorders | Custom | Systematic Assessment | Includes abdominal pain, stomach flu, gastric infection and peptic ulcer |
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| Intestinal Issues | Gastrointestinal disorders | Custom | Systematic Assessment | Includes appendicitis and bowel obstruction |
|
| Other GI Issues | Gastrointestinal disorders | Custom | Systematic Assessment | Includes weight gain, colonoscopy and hernia repair |
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| Gall Bladder Issues | Hepatobiliary disorders | Custom | Systematic Assessment | Includes cholecystectomy, cholecystitis and gallstones |
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| Liver Fibrosis | Hepatobiliary disorders | Custom | Systematic Assessment |
| |
| Fever | Immune system disorders | Custom | Systematic Assessment |
| |
| Sjogren's Syndrome | Immune system disorders | Custom | Systematic Assessment |
| |
| Systemic Allergic Reaction | Immune system disorders | Custom | Systematic Assessment |
| |
| Systemic Infection | Infections and infestations | Custom | Systematic Assessment |
| |
| Trauma | Injury, poisoning and procedural complications | Custom | Systematic Assessment | Includes motor vehicle accident, fall, trip, slip or twist |
|
| Bone Fracture - Lumbar | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
| |
| Bone Fracture - Non-Lumbar | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
| |
| Degenerative Joint Disease - Lumbar | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes arthritis, facet joint degeneration and rheumatoid arthritis |
|
| Degenerative Joint Disease - Non-Lumbar | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes inflammatory polyarthritis |
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| Joint or Muscle Issues | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes ganglion cyst, hallux rigidus, hip-joint pain, surgery, torn meniscus and trigger finger |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
| |
| Non-Lumbar Radiographic Observation | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes disc bulge and disc herniation |
|
| Pain in Non-Lumbar or Leg | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes neck and thoracic |
|
| Plantar Fascitis | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
| |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Custom | Systematic Assessment | Includes breast, colon, prostate, rectal, skin and vulvar |
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| Lower Extremity Pain | Nervous system disorders | Custom | Systematic Assessment | Includes bilateral lower leg, unilateral upper and lower leg |
|
| Lumbar Only Pain | Nervous system disorders | Custom | Systematic Assessment |
| |
| Lumbar and Lower Extremeties Sensory Deficit | Nervous system disorders | Custom | Systematic Assessment |
| |
| Lumbar and Lower Extremities Motor Deficit | Nervous system disorders | Custom | Systematic Assessment | Includes general and transient unilateral motor deficit |
|
| Lumbar and Lower Extremity Pain | Nervous system disorders | Custom | Systematic Assessment | Includes lumbar + unilateral and bilateral radiation into upper and lower leg |
|
| Non-Lumbar and Lower Extremities Deficit | Nervous system disorders | Custom | Systematic Assessment | Includes brain tumor, headache, loss of consciousness, nerve entrapment, seizure, vertigo and carpal tunnel syndrome |
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| Pregnancy Related Issues | Pregnancy, puerperium and perinatal conditions | Custom | Systematic Assessment | Includes pregnancy, delivery and miscarriages |
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| Psychosocial Disorders | Psychiatric disorders | Custom | Systematic Assessment | Includes conversion disorder, depression and suicidal attempt |
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| Substance Related Disorders | Psychiatric disorders | Custom | Systematic Assessment | Includes substance dependence and withdrawal |
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| Suicide | Psychiatric disorders | Custom | Systematic Assessment |
| |
| Benign Prostatic Hypertrophy | Renal and urinary disorders | Custom | Systematic Assessment |
| |
| Kidney Issues | Renal and urinary disorders | Custom | Systematic Assessment | Includes kidney stones |
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| Female Reproductive System Issues | Reproductive system and breast disorders | Custom | Systematic Assessment | Includes breast implant leakage, irregular menstrual bleeding and ovarian or uterine cyst or mass or tumor |
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| Male Reproductive System Issues | Reproductive system and breast disorders | Custom | Systematic Assessment | Includes erectile dysfunction and retrograde ejaculation |
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| Reproductive System Related Surgeries | Reproductive system and breast disorders | Custom | Systematic Assessment | Includes breast reduction or enhancement and hysterectomy |
|
| Breathing Disorders | Respiratory, thoracic and mediastinal disorders | Custom | Systematic Assessment | Includes dyspnea |
|
| Respiratory Infections | Respiratory, thoracic and mediastinal disorders | Custom | Systematic Assessment | Includes bronchitis and pneumonia |
|
| Device Deficiency | Surgical and medical procedures | Custom | Systematic Assessment | Includes implant expulsion, malposition, migration and subsidence |
|
| Index Procedure Related Wounds | Surgical and medical procedures | Custom | Systematic Assessment | Includes deep wounds, dural injuries and incisional hernia |
|
| Subsequent Surgical Intervention Procedure Related Wounds | Surgical and medical procedures | Custom | Systematic Assessment | Includes incisional hernia |
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| Blood Loss | Vascular disorders | Custom | Systematic Assessment |
| |
| Blood Pressure | Vascular disorders | Custom | Systematic Assessment | Includes syncope |
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| Embolism | Vascular disorders | Custom | Systematic Assessment | Includes pulmonary embolism |
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| Thrombosis | Vascular disorders | Custom | Systematic Assessment | Includes deep vein thrombosis |
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| Vascular Issues | Vascular disorders | Custom | Systematic Assessment | Includes aneurysm, atherosclerosis and iliac vessel tear |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Pressure | Vascular disorders | Custom | Systematic Assessment | Includes hypertension and syncope |
|
| Vascular Issues | Vascular disorders | Custom | Systematic Assessment | Includes aneurysm, arterial dissection, atherosclerosis and iliac vessel tear |
|
| Cardiac Issues | Cardiac disorders | Custom | Systematic Assessment | Includes arrhythmia, chest pain, heart disease and myocardial infarct |
|
| Diabetes Mellitus | Endocrine disorders | Custom | Systematic Assessment |
| |
| Eyes, Ears, Nose or Throat | Ear and labyrinth disorders | Custom | Systematic Assessment |
| |
| Gastric Issues | Gastrointestinal disorders | Custom | Systematic Assessment | Includes abdominal adhesion, abdominal pain, acid reflux, indigestion, food poisoning, GERD, gastric lesions, gastritis, stomach flu, gastrointestinal infection and peptic ulcer |
|
| Intestinal Issues | Gastrointestinal disorders | Custom | Systematic Assessment | Includes bowel irregularity, constipation, diverticulitis, GI bleed, inflammatory bowel syndrome, nausea, vomiting and diarrhea |
|
| Pregnancy Related Issues | Pregnancy, puerperium and perinatal conditions | Custom | Systematic Assessment | Includes pregnancy and delivery |
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| Male Reproductive System Issues | Reproductive system and breast disorders | Custom | Systematic Assessment | Includes epididymitis, erectile dysfunction, inguinal or testicular pain, rectocele and retrograde ejaculation |
|
| Female Reproductive System Issues | Reproductive system and breast disorders | Custom | Systematic Assessment | Includes abnormal PAP smear results, breast, ovarian or uterine cyst, mass or tumor, cystocele, menopause, vaginal or yeast infection |
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| Reproductive System Related Surgeries | Reproductive system and breast disorders | Custom | Systematic Assessment | Includes abortion, hysterectomy and lumpectomy |
|
| Urinary Issues | Renal and urinary disorders | Custom | Systematic Assessment | Includes decreased urine output, bladder infection, hematuria, incontinence, dysuria, pelvic pain, urinary hesitance, retention, urgency or tract infection |
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| Non-Procedure Allergic Reactions | Immune system disorders | Custom | Systematic Assessment | Includes seasonal and systemic allergic reactions |
|
| Infections | Infections and infestations | Custom | Systematic Assessment | Includes abscess, cellulitis and non-procedure wound infections |
|
| Anemia | Blood and lymphatic system disorders | Custom | Systematic Assessment |
| |
| High Cholesterol | Blood and lymphatic system disorders | Custom | Systematic Assessment |
| |
| Degenerative Joint Disease - Lumbar | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes ankylosing spondylitis, arthritis, arthropathy and facet joint degeneration |
|
| Plantar Fascitis | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
| |
| Joint or Muscle Issues | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes non-lumbar benign mass or tumor, bursitis, ganglion cyst, gout, hallux rigidus, hiccups, hip joint pain, non-lumbar joint sprain, leg length discrepancy, SI joint pain, surgery, torn meniscus, torn hip labral tear and trigger finger |
|
| Pain in Non-Lumbar or Leg | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes ankle, back, upper extremities, neck and thoracic, fibromyalgia, and foot |
|
| Non-Lumbar Radiographic Observation | Surgical and medical procedures | Custom | Systematic Assessment | Includes disc bulge, protrusion and herniation |
|
| Lumbar and Lower Extremity Motor Deficit | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes general, persistent and transient unilateral and bilateral motor deficit |
|
| Lumbar and Lower Extremity Sensory Deficit | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment | Includes unilateral and bilateral general and upper extremity sensory deficit, positive or change in SLR test |
|
| Reflex Change or Abnormality | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
| |
| Non-Lumbar and Lower Extremity Deficit | Nervous system disorders | Custom | Systematic Assessment | Includes Bell's palsy, brain tumor, dysphagia, memory loss, headache, loss of consciousness, migraine, nerve entrapment, numbness, restlessness, seizure, tremor, vertigo, carpal tunnel, peripheral neuropathy, upper extremity motor/sensory deficits |
|
| Lower Extremity Pain | Nervous system disorders | Custom | Systematic Assessment | Includes unilateral and bilateral upper and lower leg |
|
| Lumbar Only Pain | Nervous system disorders | Custom | Systematic Assessment |
| |
| Lumbar and Lower Extremity Pain | Nervous system disorders | Custom | Systematic Assessment | Includes lumbar + unilateral and bilateral radiation into upper and lower leg |
|
| Psychosocial Disorders | Psychiatric disorders | Custom | Systematic Assessment | Includes anxiety, bipolar and depressive disorders |
|
| Substance Related Disorders | Psychiatric disorders | Custom | Systematic Assessment | Includes substance dependence or withdrawal |
|
| Sleep Disorders | Psychiatric disorders | Custom | Systematic Assessment | Includes fatigue, sleepiness, somnolence and insomnia |
|
| Breathing Disorders | Respiratory, thoracic and mediastinal disorders | Custom | Systematic Assessment | Includes dyspnea, sleep apnea, cough and asthma |
|
| Respiratory Infections | Respiratory, thoracic and mediastinal disorders | Custom | Systematic Assessment | Includes bronchitis, respiratory and sinus infection |
|
| Other Respiratory Disorders | Respiratory, thoracic and mediastinal disorders | Custom | Systematic Assessment | Includes COPD, hemoptysis, pleuritic chest pain, reactive airway disease |
|
| Trauma | Injury, poisoning and procedural complications | Custom | Systematic Assessment | Includes motor vehicle accident, fall, trip, slip or twist |
|
| Index Procedure Related Wounds | Surgical and medical procedures | Custom | Systematic Assessment | Includes abscess, deep wound, dehiscence, dural injuries, erythema, drainage, inflammation, incisional hernia, incisional cellulitis, pain at incision site, suture reaction and wound infection |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director of Medical and Scientific Affairs | Aesculap Inc. | 800-258-1946 | 5173 | mikhail.chkolnik@aesculap.com |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| VAS Right Leg Pain |
|
| VAS Left Leg Pain |
|
| SF-36 PCS |
|
| Lateral Bending AP |
|
| Sensory |
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| Reflexes |
|
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