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 A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair. (NCT04145544), a randomized na study. The primary outcome is Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04145544 |
| Phase | NA |
| Condition | Dural Tear, Cerebrospinal Fluid Leak |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 92 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Nurami Medical Ltd |
| Results posted | Yes |
2. Clinical Question
Population
Subjects requiring dural repair during planned cranial neurosurgery. The study concerns dural tears and cerebrospinal fluid leakage.
Intervention
ArtiFascia®, a bioabsorbable synthetic dural replacement, implanted at the end of surgery according to physician discretion and its instructions for use.
Comparator
A commercially available suturable dural substitute, implanted according to physician discretion and the specific device instructions for use.
Primary question
How did the groups compare on absence of cerebrospinal fluid fistula and pseudo-meningocele within 6 months post-operative, assessed using MRI imaging and physical examination of the surgical site?
The clinical question combines an assessment of safety and effectiveness in people whose dura is cut or damaged during neurosurgery. A dural repair is intended to address the defect. The registry summary describes cerebrospinal fluid leakage and infection as concerns associated with a damaged dura, and describes ArtiFascia® as a patch intended to support regeneration of a new dura and minimize leakage.
The endpoint is framed as absence of two findings: cerebrospinal fluid fistula, described as drainage from the wound or sinus, and pseudo-meningocele. The assessment includes MRI imaging and physical examination. The record does not report a single numerical primary comparison for this endpoint, so it does not establish how the study groups compared on the stated primary question.
3. Trial Design
This was a prospective, randomized, controlled, multicenter study with a parallel-group model. The registry lists the masking as single, but does not report who was masked. The study status is completed, with enrollment of 92. The listed phase is NA. The sponsor is Nurami Medical Ltd.
Subjects with planned cranial neurosurgery participated. At the end of surgery, the treatment arm received the ArtiFascia® patch. The control arm received a commercial suturable dural substitute. In both arms, implantation was according to the physician’s clinical discretion and the relevant device instructions. The registry does not describe the randomization procedure, allocation concealment, or specific rules for choosing the commercial substitute.
The registry lists a start date of 2020-01-07 and a primary completion date of 2022-11-01. Its primary endpoint is absence of cerebrospinal fluid fistula and pseudo-meningocele within 6 months post-operative, assessed by MRI imaging and physical examination of the surgical site. Other listed outcomes are wound healing assessment, device handling characteristics from a user experience questionnaire, and radiological imaging at 6 months for additional findings at the implant site.
The record lists 4 outcome measures and 0 analyses. It does not report the number randomized to each arm, the number completing follow-up, or the analysis populations. The adverse-event record separately lists risk sets for its groups; those figures do not establish the group sizes for the primary endpoint or explain who contributed to each outcome assessment. The primary endpoint is not reduced in the record to a single comparison because it has several categories or time points.
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.
Before assignment: A total of 92 subjects met the inclusion/exclusion criteria, were randomized and enrolled. Of those 92 subjects, 89 received surgical treatment. Of those 89 treated subjects, 85 completed the study.
Overall Study
| Stage | Treatment Arm- ArtiFascia® Patch | Control-Other Commercial Suturable Dural Substitute |
|---|---|---|
| STARTED | 63 | 29 |
| Treated | 62 | 27 |
| COMPLETED | 58 | 27 |
| NOT COMPLETED | 5 | 2 |
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.
Population: Men and women between the ages of 18-75 scheduled for an elective cranial surgery that requires dural repair, meet all the inclusion and none of the exclusion criteria.
| Characteristic | Unit | Treatment Arm-ArtiFascia® Graft | Control-Other Commercial Suturable Dural Substitute | Total |
|---|---|---|---|---|
| Participants analysed | 63 | 29 | 92 | |
| Age, Categorical: <=18 years | Participants | 0 | 1 | 1 |
| Age, Categorical: Between 18 and 65 years | Participants | 48 | 23 | 71 |
| Age, Categorical: >=65 years | Participants | 15 | 5 | 20 |
| Sex: Female, Male: Female | Participants | 43 | 21 | 64 |
| Sex: Female, Male: Male | Participants | 20 | 8 | 28 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 14 | 4 | 18 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 49 | 25 | 74 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 62 | 29 | 91 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: Belgium | participants | 3 | 2 | 5 |
| Region of Enrollment: Czechia | participants | 19 | 9 | 28 |
| Region of Enrollment: Poland | participants | 28 | 12 | 40 |
| Region of Enrollment: Spain | participants | 13 | 6 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging., measured over 6 month..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint concerns the absence of cerebrospinal fluid fistula and pseudo-meningocele within 6 months post-operative. A fistula is described in the endpoint title as drainage from the wound or sinus. The registry description states that the assessment uses MRI imaging and physical examination of the surgical site. The endpoint is expressed in participants, with the outcome parameter described as a count of participants.
Assessing these findings is relevant to the clinical question because the registry describes leakage of cerebrospinal fluid as a potential consequence of dural damage. The endpoint combines two kinds of postoperative finding rather than reporting only one. It is therefore important to know how the registry classified participants who had either finding, both findings, or neither. Those classification details are not reported in the registry record.
The endpoint description identifies the assessment period, methods, and findings of interest, but the record does not provide a single numerical result for the endpoint. It also does not give a group-level count for absence of the findings, a comparison estimate, or its uncertainty. The record indicates that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, the posted information does not allow a reader to quantify the primary endpoint difference between the study groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of ArtiFascia® with other commercial suturable dural substitutes and specifies a postoperative endpoint related to cerebrospinal fluid fistula and pseudo-meningocele. However, it does not report a single numerical primary comparison. The principal question about how the groups compared on that endpoint therefore cannot be answered from the registry record alone. No primary endpoint counts, effect estimate, confidence interval, or test result are reported in the available record.
The record states that the primary outcome includes several categories or time points and is not reduced to one comparison. That matters because the wording of an endpoint is not itself an outcome result. Without the underlying group-specific categories, definitions, and counts, it is not possible to determine how many participants met the endpoint, how the combined findings were handled, or how results varied over any listed time points. The absence of a single result should not be interpreted as evidence of equivalence, benefit, or harm.
The safety entries are separately reported. For the treatment arm, the record lists 9 serious adverse events among 63 at risk, 26 other adverse events among 63 at risk, and 1 death. For the control arm, it lists 3 serious adverse events among 29 at risk, 15 other adverse events among 29 at risk, and 0 deaths. These are descriptive registry figures. The record does not provide a comparative analysis, uncertainty estimates, adjustment for differences in follow-up, or definitions that clarify whether the event counts represent participants with events or total events. They should not be treated as a causal estimate of a device effect.
Some serious adverse event terms are listed with percentages: Light chain disease, Seizure, and Vasospasm are each listed at 3.4%; Facial paresis, B-cell lymphoma, and Neoplasm of orbit are each listed at 1.6%. The record does not provide enough detail to determine from these entries alone how the percentages were calculated or how they relate to the group-level serious-event counts.
The registry’s enrollment figure describes enrollment, not necessarily the number contributing to each endpoint. The record does not report group-specific primary-endpoint denominators, missing outcome data, or the analysis population. These omissions limit interpretation of both the effectiveness endpoint and the safety entries. A careful reading distinguishes the stated study objective from the results actually reported: the objective was to evaluate safety and effectiveness, but the posted primary endpoint information does not quantify the comparison.
9. Statistical Methods Explained
Randomization is a design approach that assigns participants to study groups by chance. In general, it aims to make groups comparable with respect to both measured and unmeasured characteristics, though randomization does not guarantee balance in a particular study. The registry describes this study as randomized, but does not report the randomization sequence, how assignment was concealed, or operational details of assignment. Those details are not reported in the registry record.
A parallel-group design assigns participants to one study group, with the groups followed during the study. The registry identifies ArtiFascia® as the treatment and a commercial suturable dural substitute as the control. The record describes implantation as occurring according to physician discretion and device instructions. It does not say whether the choice among control devices followed a uniform rule, or how any differences among commercial substitutes were handled in analysis.
Masking means keeping some people involved in a study unaware of assigned treatment, to reduce the possibility that expectations influence care or assessment. The record calls the study single-masked but does not identify who was masked. Because the primary endpoint involves MRI imaging and physical examination, knowing who assessed the findings could be relevant to interpreting possible assessment bias. The record does not report assessor masking or procedures for resolving uncertain endpoint classifications.
A binary outcome distinguishes whether a defined event or condition is present. In general, an endpoint based on absence of specified findings can be analyzed by classifying each participant according to whether the endpoint criteria were met. That requires clear definitions, rules for combining findings, a defined assessment window, and an approach for participants with incomplete assessments. The registry describes the findings and the 6-month period, but does not report the classification rules or a single group comparison. Its note that the primary outcome has several categories or time points indicates that it has not been reduced to one numerical comparison in the record.
A group comparison normally needs an outcome summary for each group and an estimate of the difference or other contrast, with an indication of its uncertainty. A confidence interval, in general, describes a range of values compatible with the data under the statistical method and assumptions used. It communicates precision as well as direction: a broad interval indicates that the estimate is less precise than a narrow one. The registry does not report a primary endpoint estimate or confidence interval, so neither the magnitude nor precision of the primary comparison can be assessed.
For binary outcomes, the chosen effect measure can be a difference in event proportions, a ratio of proportions, or another contrast. These measures answer related but distinct questions and may present the same data differently. Their interpretation also depends on which outcome is counted as the event, how the denominator is defined, and whether the estimate is adjusted. None of these primary-endpoint measures is reported in the registry record. The wording of the endpoint alone is not enough to reconstruct the intended measure.
Missing outcome data can affect a comparison when participants do not have an assessable result. In general, an analysis must state how missing assessments are handled and whether the assumptions are plausible. Excluding participants with missing data, imputing outcomes, or using other approaches can lead to different estimates. The registry does not report the amount of missing primary-endpoint data or how it was handled. It also does not state which participants were included in the primary analysis.
Multiplicity arises when several outcomes, time points, or comparisons are examined. In general, conducting many statistical tests can increase the chance of a false-positive finding if the analysis does not account for that testing. A prespecified hierarchy, adjustment procedure, or focus on a clearly defined primary comparison can help readers understand how results were interpreted. The record lists 4 outcome measures and indicates that the primary outcome has several categories or time points, but does not report a multiplicity strategy or statistical analysis plan. It does not report interim analyses or a prespecified hierarchy; these details are not reported in the registry record.
The registry’s sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The stated illustrations are planning quantities, not observed power and not evidence about the trial’s actual design rationale. The record does not report a sample-size justification or the planning effect used for the trial. Any sample-size illustration should be read as conditional on its assumptions, rather than as a guarantee that a study would detect an effect or as a measure of what this completed study established.
Finally, a statistical analysis plan describes how outcomes will be defined and analyzed, including the effect measure, handling of missing data, analysis populations, and treatment of multiple comparisons. Such a plan helps distinguish prespecified methods from analyses selected after results are known. The registry record lists 0 analyses and does not report those methodological details. Without them and without a primary numerical result, readers cannot reproduce or evaluate a primary-endpoint analysis from the registry information.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 4 outcome measures, including the primary endpoint and secondary outcomes concerning wound healing, device handling characteristics, and radiological imaging at 6 months. It does not report a statistical plan for controlling multiplicity across outcomes, endpoint categories, time points, or comparisons. The record indicates that the primary outcome has several categories or time points and is not reduced to a single comparison. Without the analysis plan, it is not possible to determine whether a particular comparison was designated as the principal inferential test or whether any adjustment was intended.
Missing data and analysis populations are also not described. The record does not report how many participants had an assessable primary endpoint, how incomplete MRI or physical examination assessments were handled, or whether all randomized participants were analyzed in their assigned groups. The enrollment figure alone does not establish the denominator used for any outcome. The adverse-event risk sets are reported separately and should not be assumed to be the primary endpoint populations.
The record lists 0 analyses and does not give a primary effect estimate or uncertainty interval. It also does not report interim analyses, a detailed statistical analysis plan, or a sample-size justification. These omissions leave uncertainty about the planned inferential approach and the degree to which the posted results reflect prespecified methods. They do not, by themselves, show that an analysis was inappropriate; they mean that these procedures are not reported in the registry record.
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 |
|---|---|---|---|
| Treatment Arm-ArtiFascia® Graft | 9 | 63 | 14.3% |
| Control-Other Commercial Suturable Dural Substitute | 3 | 29 | 10.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment Arm-ArtiFascia® Graft | 1 of 63 |
| Control-Other Commercial Suturable Dural Substitute | 0 of 29 |
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 |
|---|---|
| Treatment Arm-ArtiFascia® Graft | 26 of 63 |
| Control-Other Commercial Suturable Dural Substitute | 15 of 29 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment Arm-ArtiFascia® Graft | Control-Other Commercial Suturable Dural Substitute |
|---|---|---|---|
| Facial paresis | Nervous system disorders | 1 of 63 | 0 of 29 |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 63 | 0 of 29 |
| Light chain disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 63 | 1 of 29 |
| Neoplasm of orbit | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 63 | 0 of 29 |
| Cerebral haemorrhage | Nervous system disorders | 1 of 63 | 0 of 29 |
| Extradural abscess | Infections and infestations | 1 of 63 | 0 of 29 |
| Pneumonia | Infections and infestations | 1 of 63 | 0 of 29 |
| Cardio-respiratory arrest | Cardiac disorders | 1 of 63 | 0 of 29 |
| Seizure | Nervous system disorders | 0 of 63 | 1 of 29 |
| Vasospasm | Vascular disorders | 0 of 63 | 1 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment Arm-ArtiFascia® Graft | Control-Other Commercial Suturable Dural Substitute |
|---|---|---|---|
| Epilepsy | Nervous system disorders | 3 of 63 | 0 of 29 |
| Amnesia | Nervous system disorders | 1 of 63 | 0 of 29 |
| Eyelid ptosis | Eye disorders | 1 of 63 | 0 of 29 |
| Facial paresis | Nervous system disorders | 0 of 63 | 1 of 29 |
| Taste disorder | Nervous system disorders | 0 of 63 | 1 of 29 |
| Skin infection | Infections and infestations | 1 of 63 | 0 of 29 |
| Eye swelling | Eye disorders | 0 of 63 | 1 of 29 |
| Facial paresis | Nervous system disorders | 1 of 63 | 0 of 29 |
| Vith nerve paresis | Nervous system disorders | 1 of 63 | 0 of 29 |
| Mydriasis | Eye disorders | 1 of 63 | 0 of 29 |
Serious events with the highest arm-level rate: light chain disease (3.4%), seizure (3.4%), vasospasm (3.4%), facial paresis (1.6%), b-cell lymphoma (1.6%).
The registry lists serious and other adverse events separately for the treatment and control arms. The treatment arm has 9 serious adverse events among 63 at risk and 26 other adverse events among 63 at risk; the control arm has 3 serious adverse events among 29 at risk and 15 other adverse events among 29 at risk. Deaths are listed as 1 in the treatment arm and 0 in the control arm.
These entries are descriptive counts, not a randomized comparative analysis. The registry does not report uncertainty estimates, a statistical test, event timing, exposure-adjusted rates, or details about how related events in the same participant were counted. The record also does not explain whether the counts refer to participants with at least one event or total events. Therefore, the figures should not be interpreted as an adjusted estimate of comparative safety.
The record lists Light chain disease, Seizure, and Vasospasm at 3.4% each, and Facial paresis, B-cell lymphoma, and Neoplasm of orbit at 1.6% each among the top serious terms. The registry does not explain the denominator or group distribution for these percentages. A listed term or percentage does not by itself establish causation or show how often an event occurred in each study arm.
12. What the Result Does, and Does Not, Mean
The study was designed to evaluate ArtiFascia® against commercially available dural substitutes in subjects requiring dural repair after planned cranial neurosurgery. Its primary endpoint addresses absence of cerebrospinal fluid fistula and pseudo-meningocele within 6 months post-operative, with assessment by MRI imaging and physical examination. The record also contains descriptive adverse-event entries.
Those design and endpoint details do not establish a comparative result. The registry does not report a single numerical primary-endpoint comparison, group-specific primary counts, an effect estimate, or a confidence interval. Consequently, the posted information does not quantify whether the study groups differed on the primary endpoint, or how precise any such difference might be. Lack of a reported comparison is not evidence that the treatments are equivalent, and it is not evidence that either treatment is superior or inferior.
The safety counts can be read as events recorded for the two registry groups, but they are not accompanied by an inferential comparison or the details needed to assess differences in follow-up and event counting. They cannot establish that the device caused or prevented any particular adverse event. Likewise, the listed serious-event terms and percentages do not provide a complete account of event severity, timing, relatedness, or distribution by arm.
The record’s enrollment figure should not be mistaken for the number analyzed for every outcome. Group-specific primary-endpoint denominators, missing-data handling, and analysis populations are not reported. The registry also does not report the full statistical plan, multiplicity approach, or sample-size justification. These gaps limit independent evaluation and reproducibility.
The appropriate interpretation is therefore narrow: the registry documents the trial’s design, its intended primary endpoint, and selected safety counts, but does not provide a numerical primary comparison from which to judge the endpoint contrast. The stated study objective is not itself evidence of an outcome. Readers should distinguish the purpose of the trial from the information recorded about its results.
13. Why This Trial Matters Statistically
This trial addresses a practical clinical research question: how a synthetic dural repair patch compares with commercially available suturable substitutes when a dural repair is required during planned cranial neurosurgery. Randomized allocation is relevant because it is intended to support a fair comparison by reducing systematic differences between groups. The parallel design and defined postoperative endpoint make the intended comparison identifiable, even though the registry does not report its numerical primary result.
The endpoint also illustrates why operational definitions matter. Absence of cerebrospinal fluid fistula and pseudo-meningocele combines findings assessed through MRI imaging and physical examination. Readers need to know how those findings were defined, combined, and assessed when interpreting a comparison. The registry identifies the assessment period and methods, but does not report all classification or analysis details.
From a statistical perspective, the distinction between a study objective and a reported estimate is essential. A trial can be designed to assess effectiveness and safety, yet its registry record may not include enough outcome information to evaluate the comparison. In this case, the absence of a single primary comparison, estimate, and uncertainty interval prevents assessment of both the direction and precision of the primary endpoint result.
The record also illustrates the need to interpret safety counts in context. Counts by arm are informative descriptions, but without definitions, follow-up details, participant-level accounting, and comparative uncertainty they cannot establish a treatment-related difference. Similarly, analysis populations and missing-data procedures matter because they determine which participants and assessments contribute to an estimate.
These features make transparent reporting important. Clear endpoint results, prespecified analysis methods, denominators, and uncertainty measures would allow readers to assess what the study found and how reliably. The registry information documents the design and selected safety entries, while leaving the central comparative effectiveness result unquantified.
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 main limitation for interpretation is that the registry does not report a single numerical primary endpoint comparison. It identifies several categories or time points for the primary outcome but does not provide the group-specific primary results or an effect estimate. No confidence interval or test result for that endpoint is reported. The primary question therefore cannot be quantitatively evaluated from the registry record.
Several design and analysis details are not reported: who was masked, the randomization and allocation-concealment procedures, the analysis populations, the number with an assessable primary outcome, and how missing data were handled. The record does not describe the endpoint classification rules for participants with one or both findings, or explain how multiple categories or time points were analyzed. It also does not report a multiplicity strategy, a detailed statistical analysis plan, interim analyses, or the trial’s sample-size justification.
The safety entries have their own interpretive limits. The registry does not explain whether event counts represent participants or total events, provide the timing or duration of follow-up for those entries, or report comparative estimates with uncertainty. It does not specify how the listed serious-event percentages were calculated or their distribution by arm. The recorded risk sets should not be assumed to be the denominators for the primary endpoint.
The study is described as multicenter, but the registry does not report site-level results or explain whether differences among centers were considered in analysis. The control intervention is described as a commercial suturable dural substitute, without reporting which specific substitutes were used or how their use was distributed. These are limitations of the information in the registry record; they do not establish that the underlying study failed to collect or analyze such information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair. — NCT04145544.
- Registry record last updated 2025-08-19; status last verified 2025-08.
- Results first posted 2025-08-19.
- 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
NCT04145544 is a completed prospective, randomized, controlled, multicenter, parallel-group study sponsored by Nurami Medical Ltd. It enrolled 92 subjects requiring dural repair during planned cranial neurosurgery. The study compared implantation of ArtiFascia® with a commercially available suturable dural substitute. The listed phase is NA, and masking is listed as single; who was masked is not reported in the registry record.
The primary endpoint concerns absence of cerebrospinal fluid fistula and pseudo-meningocele within 6 months post-operative, assessed by MRI imaging and physical examination. The record lists 4 outcome measures and 0 analyses, but does not report a single numerical primary comparison. It also records group-level serious and other adverse-event counts and deaths, without a comparative analysis. The statistical plan, missing-data procedures, and analysis populations are not reported.