- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04064710
Biological Allograft Chain Tissue Implant
May 12, 2021 updated by: Lenoss Medical
The Biological Allograft Chain Tissue Implant & Associated Manual Surgical Instrumentation: A Prospective, Post-Market Study
A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Vertebral compression fractures can be associated with instability and severe, persistent pain and limitation of activities.
This post market study is being conducted to assess fracture stability over time.
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dom Messerli
- Phone Number: 484-988-0477
- Email: dom.messerli@lenoss.com
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Recruiting
- University of Colorado Denver | Anschutz Medical Campus
-
Contact:
- Nicola Haakonsen
- Phone Number: 720-848-2425
- Email: Nicola.Haakonsen@cuanschutz.edu
-
Principal Investigator:
- Corey Ho, MD
-
-
New York
-
Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center
-
Contact:
- Parina Shah
- Phone Number: 718-920-6267
- Email: parishah@montefiore.org
-
Principal Investigator:
- Allan Brook, MD
-
Manhasset, New York, United States, 11030
- Recruiting
- North Shore University Hospital
-
Contact:
- Brittany Hobbie
- Phone Number: 516-693-3976
- Email: bhobbie@northwell.edu
-
Principal Investigator:
- Athos Patsalides, MD
-
New York, New York, United States, 10029
- Recruiting
- Mount Sinai
-
Principal Investigator:
- Reade De Leacy, MD
-
Contact:
- Sukaina Davdani
- Phone Number: 212-241-2524
- Email: sukaina.davdani@mountsinai.org
-
-
Oklahoma
-
Edmond, Oklahoma, United States, 73013
- Active, not recruiting
- Clinical Investigations LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Skeletally mature adult ≥ 50 years of age at the time of surgery;
- Currently in an independent living environment;
- One- or two- level, acute (within six weeks of injury), thoracic or lumbar (T6-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI/CT;
- Adequate vertebral body height and geometry for insertion of the access instruments, as determined by the investigator and suitable candidate for standard kyphoplasty or vertebroplasty procedure;
- VAS back pain score ≥ 70 mm on a 100 mm scale;
- Has central pain over the spinous process upon palpation at the planned vertebral index level;
- Has failed prior non-surgical medical management (i.e. - physical therapy, narcotic and/or non-narcotic medication)
- Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
- Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion Criteria:
- More than two levels with a vertebral compression fracture;
- Previous treated or untreated vertebral compression fracture at the to be treated level(s);
- Uncorrectable coagulopathy;
- Previous instrumented spinal surgery;
- Significant vertebral collapse defined as > 70% of original vertebral height, or a burst, or pedicle fracture;
- Degenerative scoliosis, defined as Cobb angle > 20° at any level;
- Pre-existing neurological deficit or radicular pain that is not well defined or unstable;
- Disabling back pain secondary to causes other than acute fracture;
- Inability to walk or stand prior to sustaining the vertebral compression fracture;
- Active systemic or local infection;
- Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
- Morbid obesity defined as a body mass index > 40 kg/m2;
- Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
- Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
- Currently involved in study of another investigational product that may affect outcome;
- History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
- Pregnant or planning to become pregnant during the study period;
- Involved in active spinal litigation;
- Involved in a workers compensation case;
- Prisoner or ward of the state;
- Unable to undergo a MRI/CT procedure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Allograft Tissue
Allograft tissue product for patients with painful vertebral compression fractures
|
Use allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures.
Lenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate fracture stability assessed via subject- reported pain over time
Time Frame: 12 months
|
Subject-reported pain over time using the allograft tissue will be assessed using the Visual Analog Scale (VAS) for back pain on a scale of 0mm (no pain) to 100mm (worst pain imaginable).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of Physical Disability Assessed via the Roland Morris Disability Questionnaire
Time Frame: 12 months
|
The Roland Morris Disability Questionnaire is a widely used health status measure for physical disability caused by low back pain.
Scores range from 0 to 24 with higher scores representing higher levels of pain-related disability.
|
12 months
|
Measurement of Quality of Life Assessed via the EuroQol Health Outcome Instrument (EQ-5D-3L)
Time Frame: 12 months
|
The EQ-5D-3L is a standardized instrument used as a measure of health outcomes.
It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference.
In addition, there is a Visual Analog Scale (VAS).
The VAS is the participant's rating of their health on a scale of 0 "worst imaginable health state" to 100 "best imaginable health state".
|
12 months
|
Measurement of Activities of Daily Living Assessed via the Modified Tegner Activity Level Scale
Time Frame: 12 months
|
The Modified Tegner Activity Level Scale is designed to measure a patient's activities of daily living, recreation, and competitive sports.
The scale includes an assessment of level of activity pre- and post- injury.
The scores range from 0 to 10 with a 0 representing sick leave or disability.
|
12 months
|
Frequency of Implant Related Complications
Time Frame: 12 months
|
The frequency of allograft tissue related complications will be tabulated.
Intra-operative complications, surgical time, and any other significant adverse events will be summarized as safety variables.
Adverse events will be tabulated by physician's assessment of seriousness, severity, expectedness, the event's causative relation to the allograft tissue or the Access and Cavity Creation instruments, and by elapsed time since surgery.
Adverse events that require secondary surgical intervention (SSI) will be flagged.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2019
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
August 20, 2019
First Submitted That Met QC Criteria
August 20, 2019
First Posted (Actual)
August 22, 2019
Study Record Updates
Last Update Posted (Actual)
May 14, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP-18-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vertebral Body Compression Fracture(s)
-
Centre Hospitalier Universitaire de NīmesWithdrawnVertebral Body Compression Fractures
-
AgNovos Healthcare, LLCRecruitingVertebral Fracture | Vertebral Compression Fracture | Vertebral CompressionGermany, Spain
-
AgNovos Healthcare, LLCRecruitingVertebral Compression Fracture | Vertebral Compression | Compression FractureUnited States
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National Cheng-Kung University HospitalUnknownCompression Fracture of Thoracic Vertebral Body | Spinal Compression FractureTaiwan
-
Medtronic Spine LLCCompletedVertebral Body Compression Fractures (VCFs)Germany, United States, Belgium
-
Icahn School of Medicine at Mount SinaiRecruitingVertebral Compression Fractures | Osteoporotic Vertebral Compression FracturesUnited States
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Jaseng Medical FoundationRecruitingVertebral Compression Fracture | Vertebral Compression | Korean Traditional Medicine | Integrative Korean MedicineKorea, Republic of
-
Optimus Clinical ResearchCareFusionCompletedVertebral Compression Fractures | Osteoporotic Vertebral Compression Fractures | Acute Vertebral FracturesAustralia
-
St. Louis UniversityTerminatedCompression Fracture of Thoracic Vertebral Body | Thoracic Fracture | Lumbar Fracture | Compression Fracture of Lumbar Spine | Burst Fracture of Thoracic Vertebra | Burst Fracture of Lumbar VertebraUnited States
-
University Hospital, Clermont-FerrandCompletedVertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures (VOLCANO)Vertebral Compression Fracture | Spinal TraumaFrance
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DFINE Inc.WithdrawnMultiple Myeloma | Compression Fracture of Vertebral Column
-
Benvenue Medical, Inc.CompletedSpinal Fractures | Back Injuries | Fractures, CompressionUnited States, Canada, Germany, France, Belgium
-
Orthovita d/b/a StrykerUnknownSpinal FracturesUnited States
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DFINE Inc.WithdrawnPainful Osteoporotic Vertebral Compression Fractures (VCF)United States
-
Istanbul UniversityCompleted
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H. Lee Moffitt Cancer Center and Research InstituteMedtronics, Inc.Withdrawn
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Spino Modulation Inc.TerminatedAdolescent Idiopathic Scoliosis | Juvenile Idiopathic ScoliosisCanada
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