PainNCT00205101
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
An observational study of Pain and Stenosis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Stenosis, Spondylolisthesis
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Apr 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 70 consecutive patients treated by lumbar fusion using the Triad allograft
Who may be able to join
- Voluntary consent for an observational study
- One of the following diagnoses:
- isthmic spondylolisthesis,
- degenerative spondylolisthesis,
- pseudoarthritis,
- severe foraminal stenosis, and
Show all 9Show fewer
- prior failed discectomies
- Single, two, or three level fusions
- Patients require treatment by TLIF or PLIF posterior fusion as determined by surgeon. Pedicle screw instrumentation will be placed in all cases.
Who cannot join
- Infection at operative site
- Severe osteoporosis
- Inability to return for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) surgeries. Patient participation is based on the physician determination that the patient requires one of these surgeries. Participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to standard of care except for the completion of several study questionnaires:
- Back Pain Questionnaire;
- Oswestry Disability Index Questionnaire;
- Short Form-36 (SF-36) Survey;
- Visual Analog Pain Scale (VAS); and
- The Modems Patient Satisfaction Survey.
Read more
Outcome Measurements:
- The patient's pain is scored by a VAS normalized to 100;
- Patient function is based on Oswestry scores;
- General health is assessed by SF-36 completion; and
- Overall patient satisfaction will be determined by the completion of the Modems.
- Conditions
- Pain, Stenosis, Spondylolisthesis
- Keywords
- Transforaminal lumbar interbody fusion, Posterior lumbar interbody fusion, Isthmic spondylolisthesis, degenerative spondylolisthesis, Pseudoarthritis, Severe Foraminal Stenosis
- Medical subject headings
- Pain, Constriction, Pathologic, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Triad allograft | |
| 2 | other anterior lumbar interbody fusion (ALIF) | |
| 3 | transforaminal lumbar interbody fusion (TLIF) | |
| 4 | posterior lumbar interbody fusion (PLIF) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- NuVasive
- Responsible party
- Sponsor
- Investigators
- Paul Anderson, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205101
- Sponsor's protocol ID
- HSC# 2004-0235
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2005
- Last updated
- 13 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
- ClinicalTrials.gov ID
- NCT00205101
- Acronym / sponsor ID
- HSC# 2004-0235
- Conditions
- Pain, Stenosis, Spondylolisthesis
- Keywords
- Transforaminal lumbar interbody fusion, Posterior lumbar interbody fusion, Isthmic spondylolisthesis, degenerative spondylolisthesis, Pseudoarthritis, Severe Foraminal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- NuVasive
- Study start
- Sep 2004
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Sep 2005 (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.
The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) surgeries. Patient participation is based on the physician determination that the patient requires one of these surgeries. Participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to standard of care except for the completion of several study questionnaires:
- Back Pain Questionnaire;
- Oswestry Disability Index Questionnaire;
- Short Form-36 (SF-36) Survey;
- Visual Analog Pain Scale (VAS); and
- The Modems Patient Satisfaction Survey.
Outcome Measurements:
- The patient's pain is scored by a VAS normalized to 100;
- Patient function is based on Oswestry scores;
- General health is assessed by SF-36 completion; and
- Overall patient satisfaction will be determined by the completion of the Modems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Triad allograft |
| 2 | – | –other anterior lumbar interbody fusion (ALIF) |
| 3 | – | –transforaminal lumbar interbody fusion (TLIF) |
| 4 | – | –posterior lumbar interbody fusion (PLIF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 70 consecutive patients treated by lumbar fusion using the Triad allograft
Key inclusion criteria (9 listed)
- Voluntary consent for an observational study
- One of the following diagnoses:
- Single, two, or three level fusions
- Patients require treatment by TLIF or PLIF posterior fusion as determined by surgeon. Pedicle screw instrumentation will be placed in all cases.
Key exclusion criteria (3 listed)
- Infection at operative site
- Severe osteoporosis
- Inability to return for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Paul Anderson, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Stenosis, run by University of Wisconsin, Madison at 1 site in United States.
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 9 inclusion and 3 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: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 13 Mar 2019.