This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion (NCT01430299), a non-randomized na study. The primary outcome is Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01430299 |
| Phase | NA |
| Condition | Stenosis, Spondylosis, Degenerative Changes |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 43 |
| Arms in the primary outcome | n/a |
| Lead sponsor | SeaSpine, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing instrumented posterolateral lumbar spine fusion for conditions including stenosis, spondylosis, or degenerative changes. The registry describes treatment of one to 3 spinal levels between L3 and S1 per patient. It lists enrollment as 43, but does not report how that enrollment relates to the retrospective comparison cohort.
Intervention
A prospective cohort received Integra Accell Evo3 demineralized bone matrix in the posterolateral space as an adjunct to fusion. The registry also uses the names OsteoSurge 300 and OsteoSurg 300 in its outcome and safety descriptions; the record does not explain the naming differences.
Comparator
A retrospective cohort received rhBMP-2 during posterolateral lumbar fusion. The registry says these patients were age- and sex-matched to the prospective cohort. The comparison is non-randomized and uses a historical cohort, so it is not a like-for-like randomized control comparison.
Primary question
How many radiographic assessments indicated posterolateral fusion at 12 months after surgery in the cohorts described? The registry specifies assessments, not a patient-level rate, and does not report the observed counts indicating fusion or a statistical comparison between groups.
The study objective was to prospectively evaluate Evo3 as an adjunct for posterolateral spine fusion, with retrospective comparison to a historical cohort. This is a question about radiographic evidence of fusion in the described cohorts, not a randomized estimate of the effect of one treatment relative to another. The registry's matching description identifies age and sex, but does not report whether other patient, surgical, or clinical characteristics were comparable.
The primary endpoint is framed as a count of radiographic assessments indicating fusion at 12 months. The endpoint description says each treated level was assessed twice. As a result, an assessment is not equivalent to a patient: a patient could have one to 3 treated levels, with repeated assessments for each level. The registry does not provide the counts of assessments classified as fused, or details of how those classifications were combined for analysis.
The clinical question therefore has a clear time point and radiographic focus, but the available registry record does not provide the outcome values needed to describe the observed comparison. It also does not report a statistical analysis for the endpoint.
3. Trial Design
The registry lists a non-randomized, parallel-group study with no masking. Its objective describes a prospective evaluation of Integra Accell Evo3 demineralized bone matrix as an adjunct for posterolateral spine fusion and a retrospective comparison with a historical patient cohort. The prospective cohort underwent posterolateral lumbar fusion with Evo3 in the posterolateral space. The retrospective cohort underwent the procedure with rhBMP-2 and was age- and sex-matched to the prospective cohort.
These design features matter when interpreting any difference between groups. Random allocation is not reported; the registry explicitly identifies the allocation as non-randomized. The groups also come from different time frames, since one is prospective and the comparator is historical. Matching on age and sex does not establish that groups were comparable on other characteristics, and the record does not describe additional matching variables, adjustment methods, or how the historical cohort was selected. Consequently, any observed group contrast would be an association in these cohorts, not by itself a causal estimate of a treatment effect.
The registry lists enrollment as 43. It does not explain whether this figure refers only to the prospective cohort, includes the historical cohort, or otherwise corresponds to the numbers used for the primary endpoint. The endpoint description reports 23 OsteoSurge 300 levels and 37 rhBMP-2 levels, with 46 and 74 radiographic assessments, respectively. These are levels and assessments, not a clear report of patient counts in each comparison group.
The condition field lists stenosis, spondylosis, and degenerative changes. The registry lists the study as completed, with a start in 2011-06 and primary completion in 2016-03. Phase is listed as NA. Masking is listed as none. The record does not report the protocol rationale for the design, a sample-size justification, interim analyses, or a statistical analysis plan.
The intervention terminology is not fully consistent across the record. The intervention is named Demineralized Bone Matrix, the description identifies Evo3, the primary endpoint population text refers to OsteoSurge 300, and the safety group title uses OsteoSurg 300. The registry does not explain whether those names refer to the same product or why the names differ. This should be kept in mind when connecting the endpoint and safety descriptions to the intervention cohort.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | OsteoSurg 300 | rhBMP-2 |
|---|---|---|
| STARTED | 20 | 23 |
| COMPLETED | 16 | 21 |
| NOT COMPLETED | 4 | 2 |
Analysis population for the primary outcome, as defined in the registry: One to 3 spinal levels between L3 and S1 were treated per patient. Fusion was assessed twice per treated level. There were 23 OsteoSurge 300 levels and 37 rhBMP-2 levels but 46 OsteoSurge assessments and 74 rhBMP-2 assessments.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | OsteoSurg 300 | rhBMP-2 | Total |
|---|---|---|---|---|
| Participants analysed | 16 | 21 | 37 | |
| Age, Customized: participants over 18 years of age | Participants | 16 | 21 | 37 |
| Sex: Female, Male: Female | Participants | 9 | 8 | 17 |
| Sex: Female, Male: Male | Participants | 7 | 13 | 20 |
| Region of Enrollment: United States | Participants | 16 | 21 | 37 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | radiographic assessments |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of radiographic assessments indicating posterolateral fusion at 12 months after surgery. It measures radiographic evidence at a specified follow-up point, rather than a patient-reported outcome or a clinical event. The registry describes it as a count of assessments and states that fusion was assessed twice per treated level.
A count can describe how often an event or finding was recorded, but its interpretation depends on what is counted and on the number of opportunities for that finding to occur. Here, patients could have one to 3 treated spinal levels between L3 and S1, and each treated level was assessed twice. Thus the assessment count is not interchangeable with a count of patients, and repeated assessments from a level or patient may not be statistically independent. Analyses that treat correlated observations as independent can give misleadingly precise uncertainty estimates; methods for clustered or repeated observations may be needed, depending on the analysis.
The record states that there were 23 OsteoSurge 300 levels and 37 rhBMP-2 levels, corresponding to 46 and 74 assessments. It does not report how many assessments indicated fusion, how missing or unreadable assessments were handled, or whether the analysis accounted for clustering. It also does not give a patient-level definition of fusion or a threshold for the radiographic classification. These details are not reported in the registry record, so the endpoint can be described but its observed result and analytic interpretation cannot be reconstructed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a primary outcome and gives the structure of its measurement: radiographic assessments for posterolateral fusion at 12 months, repeated twice for each treated level. It also reports the number of treated levels and assessments described for each cohort. It does not report the number of assessments indicating fusion, an effect estimate, a confidence interval, a p-value, or an analysis of the primary outcome. Therefore, the posted registry record does not support a numerical conclusion about the observed fusion comparison.
The available design information is important to any future interpretation of a group contrast. The Evo3 group was prospective, while the rhBMP-2 group was retrospective and historical. The record describes age- and sex-matching, but does not say whether other prognostic factors were addressed or whether an adjusted analysis was performed. Groups assembled in different ways or at different times can differ for reasons other than the intervention. Matching on specified characteristics does not remove every possible source of confounding.
The primary endpoint counts assessments rather than patients. Since each treated level was assessed twice and patients could have multiple treated levels, the observations may be correlated within a level or patient. General statistical principle: when repeated or clustered observations are treated as independent despite correlation, standard errors can be too small and confidence intervals can be too narrow. The registry does not report the analytic unit or whether a method for dependence was used. Without that information, the precision of any comparison cannot be evaluated from the record.
The distinction between levels, assessments, and patients also limits simple interpretation of the reported counts. Assessment totals do not tell a reader how many patients had fusion, and the record does not provide counts of positive assessments. A patient-level summary could differ from an assessment-level summary, especially when patients have differing numbers of treated levels. No conversion between those units can be made from the registry information.
The safety listing contains separate group counts for people at risk and affected, as well as deaths and serious-event terms. These safety figures are descriptive registry entries. They do not resolve the primary radiographic question, and the record does not report a statistical comparison of safety between the cohorts. The safety section also does not give event-level timing, exposure duration, or a fuller definition of how events were collected. Differences in descriptive counts should not be taken as a treatment effect without appropriate context and analysis.
For the same reasons, the sample-size illustrations should not be confused with observed evidence. Their stated assumptions use an effect based on the observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation. The record does not report the primary observed effect or planning values in the registry record describing the endpoint. Planning illustrations are hypothetical design calculations, not observed power and not evidence that the study had a particular probability of detecting a real effect.
Overall, the record provides design and measurement details but no primary outcome result or inferential analysis. The most defensible reading is that the registry describes how the comparison was structured and what was intended to be counted; it does not provide enough results to quantify the comparison or its uncertainty.
9. Statistical Methods Explained
What does a confidence interval communicate?
General statistical explanation: a confidence interval describes the precision of an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision under those assumptions, while a wider interval indicates more uncertainty. It does not by itself establish that a difference is clinically important or that a causal effect has been identified. The registry record does not report a confidence interval for the primary endpoint, so no interval can be interpreted for this study from the available record.
What would a p-value mean?
General statistical explanation: a p-value assesses how compatible the observed data are with a specified statistical null model, assuming that model and its assumptions are appropriate. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. The record reports no p-value or primary endpoint analysis. No significance conclusion can therefore be drawn from the registry information.
Why does the unit of analysis matter?
The endpoint counts radiographic assessments. The registry says each treated level was assessed twice and that patients could have one to 3 treated levels. This creates a structure in which assessments can be nested within levels and patients. General statistical explanation: observations from the same person or anatomical level often share characteristics, so they may be correlated. Treating correlated observations as independent can understate uncertainty. Analysis methods can account for clustering or repeated observations, but the record does not report which method, if any, was used.
Another issue is the distinction between the level at which data are recorded and the level at which a conclusion is intended. An assessment-level count answers a question about assessment records. A patient-level rate answers a different question about people. A level-level summary is yet another description. These summaries need not agree, because patients can contribute different numbers of levels and assessments. The registry gives counts of levels and assessments but does not report patient-level endpoint results or a method for combining repeated assessments.
How should the historical comparison be understood?
The registry describes a prospective Evo3 cohort and an age- and sex-matched retrospective rhBMP-2 cohort. General statistical explanation: randomization helps balance measured and unmeasured prognostic factors on average, whereas matching addresses only the characteristics used in the matching process. In a historical comparison, differences in patient selection, clinical practice, measurement, follow-up, or other factors may influence a contrast. The record does not describe additional adjustment, the selection procedure for the historical cohort, or whether outcome assessment was conducted similarly across cohorts. These omissions prevent a detailed assessment of comparability.
Non-randomized comparisons can still be informative descriptions of outcomes in defined cohorts, but the interpretation depends on design and analysis. A difference in observed counts would not automatically identify an intervention effect. The registry record contains no primary outcome values or inferential analysis, so even a descriptive contrast cannot be stated from this information.
What do the planning assumptions represent?
The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These are assumptions for planning calculations, not a report of the study's original design rationale. The registry does not report a sample-size justification or the statistical plan used to analyze the endpoint.
General statistical explanation: a planning calculation asks how much information a future study might need under specified assumptions. Its answer depends on the target effect, variability or event frequency, allocation, analysis method, and error criterion. Changing those assumptions changes the resulting planning requirement. A calculation based on an observed effect is especially dependent on how that effect was estimated. It should be treated as an illustration rather than proof that a completed study was adequately sized.
Power is a design property under a specified statistical model and assumed effect; it is not a measure of how persuasive a completed result is. A retrospective calculation based on an observed result is not observed power. The registry's planning assumptions should therefore be read as hypothetical design inputs, not as a statement about the probability that the completed study detected a true effect. No planning output is described in the registry record, and no new sample-size values can be inferred.
What do the safety percentages and counts describe?
The safety listing presents affected and at-risk counts for serious and other events, along with deaths. It also lists serious-event terms with percentages. General statistical explanation: counts and percentages require a clearly defined denominator and observation period to support interpretation. The registry identifies at-risk group counts for the broad serious and other event summaries, but does not identify the denominator underlying each listed term percentage in the information reported. The percentages should therefore be read as registry entries, not converted into event rates or compared as if exposure and ascertainment were known to be equivalent.
For serious events, one person can potentially contribute more than one event term, depending on the registry's collection and coding rules. The record does not explain whether the listed terms represent participants, event episodes, or another reporting unit. The event terms do not establish severity beyond their placement in the serious-event listing, nor do they by themselves indicate causation. A causal safety comparison would require fuller information about definitions, follow-up, exposure, and analytic methods.
In sum, standard statistical concepts help explain what kinds of information would be needed to assess precision, dependence, and group comparability. They cannot substitute for the missing endpoint results, analysis details, or definitions in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and zero analyses. It does not report multiple primary comparisons, secondary outcome results, or a statistical analysis plan. Whether the study planned multiple tests, and whether any adjustment for multiplicity was intended, is not reported in the registry record. Without that information, it is not possible to determine how the primary outcome was selected or how any family of statistical tests was handled.
General statistical explanation: when many outcomes, time points, subgroups, or comparisons are tested, the chance of obtaining at least one apparently unusual result can increase. Methods for controlling multiplicity may be used when a study has a defined set of tests. This general issue should not be mistaken for evidence that this study did or did not conduct multiple tests; the record does not provide that detail.
The record describes assessment counts and treated levels, but does not report missing, unreadable, or unevaluable radiographs. It does not state how missing assessments were handled or whether all enrolled patients and levels contributed to the endpoint. The analysis population is not reported in the registry record. In particular, the record does not identify a patient-level population for the primary analysis or explain how the retrospective cohort was included.
Missing outcomes can affect both the size and interpretation of an analysis, especially if the likelihood of missingness is related to patient characteristics or outcome status. General statistical explanation: complete-case analysis, imputation, and sensitivity analyses rely on different assumptions. Since the record gives no missing-data handling method or analysis population, none can be attributed to this study. The available information is insufficient to assess the impact of missingness, multiplicity, or population definitions on the primary comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| OsteoSurg 300 | 5 | 16 | 31.2% |
| rhBMP-2 | 3 | 21 | 14.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| OsteoSurg 300 | 0 of 16 |
| rhBMP-2 | 0 of 21 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| OsteoSurg 300 | 9 of 16 |
| rhBMP-2 | 15 of 21 |
Most frequent serious adverse event terms
| Event term | Organ system | OsteoSurg 300 | rhBMP-2 |
|---|---|---|---|
| Hematoma | Blood and lymphatic system disorders | 1 of 16 | 1 of 21 |
| Loss of sensory and/or motor function | Nervous system disorders | 1 of 16 | 0 of 21 |
| Myocardial Infarction | Cardiac disorders | 1 of 16 | 0 of 21 |
| Neurologic deficit | Nervous system disorders | 1 of 16 | 0 of 21 |
| Unresolved pain | Nervous system disorders | 1 of 16 | 0 of 21 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 1 of 16 | 0 of 21 |
| Respiratory issues | Respiratory, thoracic and mediastinal disorders | 0 of 16 | 1 of 21 |
| Vomiting | Gastrointestinal disorders | 0 of 16 | 1 of 21 |
Most frequent non-serious adverse event terms
| Event term | Organ system | OsteoSurg 300 | rhBMP-2 |
|---|---|---|---|
| Unresolved Pain | Nervous system disorders | 8 of 16 | 9 of 21 |
| Dural Tear | Nervous system disorders | 3 of 16 | 4 of 21 |
| Myocardial Infarction | Cardiac disorders | 0 of 16 | 2 of 21 |
| Urinary Incontinence | Renal and urinary disorders | 0 of 16 | 1 of 21 |
| Fractured Toe | Musculoskeletal and connective tissue disorders | 1 of 16 | 0 of 21 |
| Gait disturbance | Nervous system disorders | 0 of 16 | 1 of 21 |
| Loss of sensory and/or motor function | Nervous system disorders | 1 of 16 | 0 of 21 |
| Numbness/Tingling | Nervous system disorders | 0 of 16 | 1 of 21 |
| Swelling | Blood and lymphatic system disorders | 0 of 16 | 1 of 21 |
| Thrombosis | Cardiac disorders | 0 of 16 | 1 of 21 |
Serious events with the highest arm-level rate: hematoma (6.2%), loss of sensory and/or motor function (6.2%), myocardial infarction (6.2%), neurologic deficit (6.2%), unresolved pain (6.2%).
The registry reports serious-event summaries for OsteoSurg 300 and rhBMP-2. For OsteoSurg 300, 16 were at risk and 5 were affected; for rhBMP-2, 21 were at risk and 3 were affected. For other events, 16 were at risk and 9 were affected in the OsteoSurg 300 group, while 21 were at risk and 15 were affected in the rhBMP-2 group. Deaths are listed as 0 for each group. These are descriptive counts as recorded, not a statistical comparison.
The registry lists Hematoma, Loss of sensory and/or motor function, Myocardial Infarction, Neurologic deficit, Unresolved pain, and Pulmonary embolism, each with 6.2%. The record does not explain the denominator for these term-specific percentages or whether each term counts affected participants, event episodes, or another unit. The percentages should not be interpreted as rates without that definition and information on follow-up and exposure.
General statistical explanation: safety counts are most interpretable when event definitions, observation time, ascertainment procedures, and denominators are clear. The registry does not report all of these details. The groups are also non-randomized, and the record does not report a safety analysis adjusting for group differences. Thus the listed counts describe reported events in the registry cohorts; they do not establish that one intervention caused more or fewer events.
12. What the Result Does, and Does Not, Mean
The record establishes that a prospective cohort receiving Evo3 was compared with a retrospective, age- and sex-matched historical cohort receiving rhBMP-2. It specifies a radiographic endpoint at 12 months and explains that assessments were repeated twice per treated level. The record also gives the numbers of levels and assessments described for the groups. Those details clarify what the endpoint was intended to measure and why its unit matters.
The record does not report the number of radiographic assessments indicating fusion. It also does not report a primary outcome estimate, confidence interval, p-value, or statistical analysis. Consequently, the registry information does not show the direction, magnitude, or precision of the primary comparison. It cannot establish whether the cohorts had similar or different radiographic findings.
Even if a group contrast were available, the design would require cautious interpretation. The comparison is non-randomized and uses a retrospective historical cohort. Matching is reported for age and sex, but other sources of differences are not addressed in the available record. A contrast could reflect the intervention, differences between cohorts, or both. It would not by itself establish causation.
The endpoint is based on assessments rather than patients, with repeated measurements and multiple treated levels possible. Without the analysis method and patient-level results, assessment counts cannot be translated into a patient-level probability of fusion. The registry also does not report how missing assessments were handled or how dependence among observations was addressed.
The safety entries describe serious and other event counts, deaths, and a list of serious-event terms. They do not provide enough information to estimate comparative safety over a defined exposure period or to attribute events to an intervention. The record's enrollment figure also cannot be confidently reconciled with the endpoint level and assessment counts or with the historical cohort.
Accordingly, the registry provides a description of study design, endpoint structure, and safety entries, but not the results needed to judge the primary comparison. That distinction is central: a specified outcome is not the same as a reported outcome, and a study's existence does not establish a treatment effect.
13. Why This Trial Matters Statistically
This study illustrates why the unit of observation should be checked before interpreting a clinical endpoint. The primary measure is a count of radiographic assessments, while the clinical population is described in terms of patients and treated spinal levels. Each treated level was assessed twice, and patients could have more than one treated level. This structure raises questions about clustering, repeated observations, and whether the reported analysis targets assessments, levels, or patients.
It also illustrates the limits of a historical comparison. Age- and sex-matching is reported, but it is not equivalent to random allocation and does not show that other prognostic factors were balanced. A prospective cohort and a retrospective cohort can differ in selection, data collection, follow-up, and other ways. Statistical adjustment can address some measured differences, but the registry does not say whether it was used, and unmeasured differences can remain.
Another statistical lesson is that endpoint description and endpoint results are separate. The record specifies a 12-month radiographic measure and its assessment structure, yet does not report the fusion assessment counts or an analysis. Without those results, readers cannot evaluate effect size or precision. The absence of a reported result in the registry record is not evidence of no difference; it is a limit on what can be concluded from this record.
Finally, the safety entries show why denominators and event definitions matter. The record lists counts and term percentages, but does not explain the term-specific denominators or observation period. Those details are essential for interpreting rates and comparing groups. Taken together, these features make the study useful as an example of the questions analysts must ask about cohort construction, repeated measures, outcome reporting, and safety ascertainment before drawing statistical conclusions.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report the primary endpoint values, an effect estimate, confidence interval, p-value, or statistical analysis. This is the main limitation for interpreting the clinical comparison: the described endpoint cannot be quantified from the record. The record also lists zero analyses, so it does not provide an analysis of the primary outcome to evaluate.
The study is non-randomized, with a prospective Evo3 cohort and a retrospective rhBMP-2 historical cohort. Age- and sex-matching is described, but the record does not report other matching variables, criteria for selecting historical patients, or adjustment for potential confounders. It does not explain whether measurement and follow-up procedures were comparable across cohorts. These features limit causal interpretation of any group contrast.
The measurement structure creates further uncertainty. The endpoint counts assessments, with two assessments per treated level and one to 3 treated levels per patient. The record does not report whether the analysis accounted for correlation among assessments within levels or patients. Nor does it explain whether the target of analysis was an assessment, a level, or a patient. Patient-level endpoint counts are not reported.
The record does not state how missing, unreadable, or unevaluable radiographic assessments were handled, or define the analysis population. It does not report a sample-size justification, interim analyses, or a statistical analysis plan. The enrollment figure of 43 is not reconciled with the described levels, assessments, or historical cohort. Product naming also differs across intervention, endpoint, and safety descriptions; the record does not clarify those labels.
For safety, the record does not explain the term-specific percentage denominators, event-level timing, duration of observation, or event collection methods. These omissions limit interpretation of comparative safety. The registry information therefore supports a description of the design and reported safety entries, but not a full evaluation of outcome precision, missingness, comparability, or causal effects.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion — NCT01430299.
- Registry record last updated 2018-06-07; status last verified 2018-05.
- Results first posted 2018-02-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed, non-randomized, unmasked, parallel-group study of Evo3 demineralized bone matrix as an adjunct to posterolateral lumbar fusion, with a retrospective historical rhBMP-2 cohort matched on age and sex. Enrollment is listed as 43. The primary outcome is the number of radiographic assessments indicating fusion at 12 months; assessments were performed twice per treated level. The record describes 23 OsteoSurge 300 levels and 37 rhBMP-2 levels, with 46 and 74 assessments, respectively.
The registry does not report the number of assessments indicating fusion or a statistical analysis of the primary outcome. Safety entries include serious and other event counts, deaths, and serious-event terms with percentages, but key details for interpreting those percentages are not reported. The historical, non-randomized design and repeated assessment structure limit causal and precision claims. The record supports a description of what was planned and how outcomes were structured, but not a quantified conclusion about the primary comparison.