Degenerative Disc DiseaseAPPROACH-001NCT00974623
Bone Graft Materials Observational Registry
An observational study of Degenerative Disc Disease and Herniated Disc, run by Baxter Healthcare Corporation at 14 sites in 3 countries.
Trial summary
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Herniated Disc, Spinal Stenosis
- What is being tested?
- Bone graft substitute, autograft or allograft
- Type of treatment
- Medical device
- How many people
- 329 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Sep 2009to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in this study will be identified from the surgeon's medical practice and will include patients who failed conservative care and have been identified as requiring spinal fusion surgery.
Who may be able to join
- The patient has failed conservative treatment and is a candidate for spinal fusion surgery.
- The patient is ≥18 years old and of legal age of consent.
- The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
- The patient is skeletally mature (epiphyses closed).
- The patient has signed the IRB approved informed consent.
- The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years.
Who cannot join
- Patient has systemic infection or infection at the surgical site.
- Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.).
- Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease).
- Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up.
- The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study.
- Patient is participating in another investigational study, which could confound results.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States12 sites
St. Joseph's Hospital - Resurgeons Orthopedics
Atlanta, Georgia, 30342
Carrollton Orthopedics
Carrollton, Georgia, 30117
Physicians Research Options Spine Center
Las Vegas, Nevada, 89144
Bluegrass Orthopedics & Hand Care Research
Lexington, Kentucky, 40509
Montana Neuroscience Institute Foundation
Missoula, Montana, 59802
Neurosurgical Associates
Nashville, Tennessee, 37203
Brain & Spine of Texas
Plano, Texas, 75093
UCSF
San Francisco, California, 94143
PRESSD
Southfield, Michigan, 48072
Syracuse Orthopedic Specialists
Syracuse, New York, 13215
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Arthritis & Joint Center - U. Mass. Memorial
Worcester, Massachusetts, 01605
About this study
Official title: A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
- Conditions
- Degenerative Disc Disease, Herniated Disc, Spinal Stenosis, Spondylolithesis, Spinal Deformity, Cervical Myelopathy
- Being tested
- Bone graft substitute, autograft or allograft
- Keywords
- Bone growth substitute, Autograft, Allograft, Spine fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis, Spondylolisthesis, Failed Back Surgery Syndrome, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone graft substitute, autograft or allograftDevice
Also called Autograft, Allograft/DBM, Ceramics, Synthetics
spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft
| Study group | Role | What they receive |
|---|---|---|
| Spinal Fusion | Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft). Receives: Device: Bone graft substitute, autograft or allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of successful radiographic fusion
Measured: 6 months, 12 months & 24 months
Secondary outcomes (2)
Maintenance or improvement in neurological status, as compared to baseline scores
Measured: 6 months 12 months & 24 months
Improvement of pain/function in comparison to pre-operative QOL scores
Measured: 6 months, 12 months & 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionNov 2013
Why it stopped: Parent sponsor company (Baxter Healthcare) company cut funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apatech, Inc.
- Responsible party
- Sponsor
- Investigators
- Huub Kreuwel, Ph.D, Study director, Director of Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974623
- Sponsor's protocol ID
- APPROACH-001
- Acronym
- APPROACH-001
- Status last verified
- Apr 2017
- First submitted
- 8 Sep 2009
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice
- ClinicalTrials.gov ID
- NCT00974623
- Acronym / sponsor ID
- APPROACH-001 / APPROACH-001
- Conditions
- Degenerative Disc Disease, Herniated Disc, Spinal Stenosis, Spondylolithesis, Spinal Deformity, Cervical Myelopathy
- Keywords
- Bone growth substitute, Autograft, Allograft, Spine fusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Parent sponsor company (Baxter Healthcare) company cut funding
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Apatech, Inc.
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Fusion | – | Device: Bone graft substitute, autograft or allograftPatients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in this study will be identified from the surgeon's medical practice and will include patients who failed conservative care and have been identified as requiring spinal fusion surgery.
Key inclusion criteria (6 listed)
- The patient has failed conservative treatment and is a candidate for spinal fusion surgery.
- The patient is ≥18 years old and of legal age of consent.
- The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
- The patient is skeletally mature (epiphyses closed).
- The patient has signed the IRB approved informed consent.
Key exclusion criteria (6 listed)
- Patient has systemic infection or infection at the surgical site.
- Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.).
- Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease).
- Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up.
- The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone graft substitute, autograft or allograftAlso: Autograft, Allograft/DBM, Ceramics, Syntheticsspine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft | Device | Spinal Fusion |
Primary outcome
Evidence of successful radiographic fusion
Time frame: 6 months, 12 months & 24 months
2 secondary outcomes
Maintenance or improvement in neurological status, as compared to baseline scores
Time frame: 6 months 12 months & 24 months
Improvement of pain/function in comparison to pre-operative QOL scores
Time frame: 6 months, 12 months & 24 months
Results and safety
The study was stopped early (reason given: Parent sponsor company (Baxter Healthcare) company cut funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huub Kreuwel, Ph.D study director
Director of Medical Affairs
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Herniated Disc, run by Baxter Healthcare Corporation at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Hungary, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Parent sponsor company (Baxter Healthcare) company cut funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of successful radiographic fusion (time frame: 6 months, 12 months & 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.