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 Cervical Spondylotic Myelopathy Surgical Trial (NCT02076113), a randomized na study. The primary outcome is Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02076113 |
| Phase | NA |
| Condition | Cervical Spondylosis With Myelopathy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 269 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Lahey Clinic |
| Results posted | Yes |
2. Clinical Question
Population
People with cervical spondylosis with myelopathy; the study’s stated purpose focuses on patients with multi-level cervical spondylotic myelopathy. The condition is a disorder involving the cervical spine and spinal cord, but the registry record does not provide further eligibility details in the information.
Intervention
Ventral decompression with fusion, described as a front approach. The study asks whether this approach produces a different patient-reported physical health outcome from dorsal surgery.
Comparator
Dorsal surgery: dorsal decompression with fusion or dorsal laminoplasty. These are distinct procedures, although the primary analysis is described as a randomized comparison of ventral versus dorsal treatment.
Primary question
How does change in the SF-36 Physical Component Score from baseline to follow-up compare between ventral and dorsal surgery? The stated primary outcome time points are 1 year and 2 year. The registry describes a hypothesis of superior 1-year SF-36 PCS outcome with ventral surgery, but numerical results for the outcome are not reported in the registry record.
The trial also describes a hypothesis that both surgical approaches improve symptoms of spinal cord dysfunction measured with the modified Japanese Orthopedic Association Score. Other stated questions concern health resource use across ventral fusion, dorsal fusion, and dorsal laminoplasty, and whether postoperative cervical sagittal balance predicts SF-36 PCS outcome. These are separate questions from the primary randomized comparison. The registry record identifies additional patient-reported, work-status, complication, and resource-use outcomes, but numerical results for those outcomes are not reported in the registry record.
3. Trial Design
This is a randomized, parallel-group study with no masking. The registry record lists an enrollment of 269 and identifies Lahey Clinic as the sponsor. The study concerns cervical spondylosis with myelopathy and compares surgical approaches. It lists three procedures: ventral decompression with fusion, dorsal decompression with fusion, and dorsal laminoplasty. For the primary analysis, the randomized groups are described more broadly as ventral versus dorsal; the dorsal group combines dorsal decompression with fusion and dorsal laminoplasty.
The record lists the study start as 2014-04-01 and primary completion as 2018-03-30. Its status is active, not recruiting. The phase is listed as not applicable. These registry entries describe the design and administrative status; they do not establish that results are complete or available for every outcome.
The primary outcome is change in SF-36 Physical Component Score from baseline to 1 year and 2 year. The record says the primary analysis was conducted as randomized. At 1 year, 60/63 ventral participants and 95/100 dorsal participants were available for analysis. At 2 year, 51/63 ventral participants and 79/100 dorsal participants were available for analysis. These counts describe analysis availability, not the magnitude or direction of the outcome.
Other listed measures include the SF-36 PCS, Oswestry Neck Disability Index, EuroQol-5D, modified Japanese Orthopedic Association Score, sagittal balance measurements, health resource utilization, work status, and complications. No further allocation procedures, masking procedures beyond the designation of none, or detailed protocol specifications are reported in the registry record.
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: 269 participants were eligible and enrolled; 163 randomized for treatment and 91 enrolled in a non-randomized cohort because either 80% or greater of review panel selected one surgical approach over the other (76), the participant did not consent to randomization (13), or at least 50% of review panel did not favor randomization (equipoise). 15 withdrew prior to randomization. Primary analysis compared ventral surgical approach to dorsal surgical approach.
Overall Study
| Stage | Ventral | Dorsal |
|---|---|---|
| STARTED | 63 | 100 |
| Surgery as randomized | 62 | 96 |
| 3-Month Follow-up | 56 | 90 |
| 6-Month Follow-up | 53 | 91 |
| 1-Year Follow-up | 60 | 95 |
| 2-Year Follow-up | 51 | 79 |
| COMPLETED | 56 | 93 |
| NOT COMPLETED | 7 | 7 |
Reasons for not completing this period:
| Reason | Ventral | Dorsal |
|---|---|---|
| Lost to Follow-up | 4 | 1 |
| Withdrawal by Subject | 2 | 3 |
| Death | 1 | 3 |
Analysis population for the primary outcome, as defined in the registry: Primary analysis was conducted as-randomized (ventral vs. dorsal). At 1 year, there were 60/63 ventral participants and 95/100 dorsal participants available for analysis. At 2 year, there were 51/63 ventral participants and 79/100 dorsal participants available for analysis. Estimated mean change was calculated from the baseline SF-36 PCS score.
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: Primary analysis compared ventral surgical approach to dorsal surgical approach for treatment of cervical spondylotic myelopathy.
| Characteristic | Unit | Ventral | Dorsal | Total |
|---|---|---|---|---|
| Participants analysed | 63 | 100 | 163 | |
| Age, Continuous | years | 62 (SD 7.2) | 62.5 (SD 8.8) | 62.3 (SD 8.2) |
| Sex: Female, Male: Female | Participants | 29 | 51 | 80 |
| Sex: Female, Male: Male | Participants | 34 | 49 | 83 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 4 | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 61 | 96 | 157 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): Asian | Participants | 2 | 3 | 5 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 7 | 13 |
| Race (NIH/OMB): White | Participants | 54 | 85 | 139 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 2 |
| Region of Enrollment: Canada | participants | 5 | 5 | 10 |
| Region of Enrollment: United States | participants | 58 | 95 | 153 |
| Baseline work status: Working full-time | Participants | 17 | 40 | 57 |
| Baseline work status: Retired | Participants | 14 | 29 | 43 |
| Baseline work status: Not working, unable to work | Participants | 17 | 18 | 35 |
| Baseline work status: Not working but able to work | Participants | 8 | 7 | 15 |
| Baseline work status: Working part-time | Participants | 7 | 4 | 11 |
| ASA physical status class: 1 (healthy) | Participants | 0 | 1 | 1 |
| ASA physical status class: II (mild systemic disease) | Participants | 31 | 46 | 77 |
| ASA physical status class: III (significant systemic disease) | Participants | 30 | 51 | 81 |
| Number of stenotic levels | levels | 2.8 (SD 0.7) | 2.8 (SD 0.8) | 2.8 (SD 0.7) |
| Number of stenotic levels: 1 | Participants | 0 | 3 | 3 |
| Number of stenotic levels: 2 | Participants | 22 | 29 | 51 |
| Number of stenotic levels: 3 | Participants | 33 | 55 | 88 |
| Number of stenotic levels: 4 | Participants | 8 | 11 | 19 |
| Number of stenotic levels: 5 | Participants | 0 | 2 | 2 |
| Neck Disability Index (NDI) score | units on a scale | 38.6 (SD 19.1) | 35.3 (SD 20.4) | 36.6 (SD 19.9) |
| SF-36 mental component score | units on a scale | 45.6 (SD 12.2) | 46.6 (SD 12.1) | 46.2 (SD 12.1) |
| SF-36 physical component score | units on a scale | 37.4 (SD 8.8) | 37.3 (SD 9.9) | 37.3 (SD 9.5) |
| mJOA scale score | units on a scale | 12.2 (SD 2.7) | 12.1 (SD 2.2) | 12.2 (SD 2.4) |
| EQ-5D score | units on a scale | 0.64 (SD 0.21) | 0.61 (SD 0.21) | 0.62 (SD 0.21) |
6. Primary Endpoint
The registry lists the primary outcome as Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year, measured over 1 year and 2 year.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the Short Form-36 Physical Component Score from baseline to follow-up at 1 year and 2 year. SF-36 is a standardized patient-reported measure of functional health and well-being. Its physical component summary score ranges from 0 to 100, with higher scores representing better quality of life. A change score expresses how the measured outcome differs from the participant’s baseline value; the registry record does not report the numerical change estimates.
A patient-reported physical health measure can capture aspects of function and well-being that matter to participants and may not be represented by a surgical or imaging measure alone. Comparing change between randomized groups is intended to describe whether the average change differs between the assigned approaches. The record frames the primary comparison as ventral versus dorsal surgery, with dorsal surgery including fusion or laminoplasty.
The endpoint is specified at two follow-up times, so each time point represents a distinct assessment of the outcome. Interpretation would depend on the estimated group changes, the between-group contrast, and its uncertainty at each time. The numerical means, standard deviations, confidence intervals, and significance tests for these comparisons are not reported in the registry record. The available participant counts therefore indicate how many were included in analysis, but do not show what happened to their scores.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record states the primary outcome definition and reports how many participants were available for analysis at the two follow-up times. It does not report estimated mean changes, standard deviations, between-group contrasts, confidence intervals, or p values for the primary outcome. Consequently, the posted information does not establish the size, direction, or precision of the difference in SF-36 PCS change between ventral and dorsal surgery. The hypothesis that ventral surgery has a superior 1-year outcome is a stated research question, not a result.
At 1 year, 60/63 ventral participants and 95/100 dorsal participants were available for analysis. At 2 year, 51/63 ventral participants and 79/100 dorsal participants were available for analysis. These figures describe analysis availability in each randomized group. They do not reveal the scores of participants who were analyzed, explain why other participants were unavailable, or show whether availability differed in ways related to outcome. The registry record does not report those reasons or a missing-data analysis.
The primary analysis is described as as-randomized. In general, an as-randomized comparison retains the basis of random assignment when grouping participants for analysis, supporting interpretation of the comparison as one between assigned approaches. That label alone does not explain how missing outcomes were handled or whether all randomized participants contributed outcome measurements. Such details are not reported in the registry record.
The study includes three surgical procedures, while the primary comparison combines the two dorsal procedures into one dorsal group. This means the primary question is about ventral versus dorsal surgery as defined in the record, not a reported separate randomized comparison of ventral surgery with each dorsal procedure. Secondary outcomes and actual-treatment-group descriptions distinguish ventral fusion, dorsal fusion, and dorsal laminoplasty, but their numerical results are not reported in the registry record.
The record describes a continuous outcome reported as a mean with standard deviation. A mean summarizes the average score change in a group; a standard deviation describes how spread out individual changes are around that average. Neither alone gives the uncertainty in the between-group comparison. Confidence intervals would help show a range of values compatible with the data under the analysis assumptions, while a p value would address compatibility with a specified null hypothesis. These numerical summaries are not reported for the primary endpoint.
Accordingly, the statistical interpretation is limited to the trial’s stated question, outcome definition, analysis population description, and available counts. The record does not provide evidence from which to judge whether the observed primary outcome difference was large, small, precise, or statistically distinguishable from no difference. The outcome results are not reported in the registry record.
9. Statistical Methods Explained
The primary outcome is continuous: it is a numerical SF-36 Physical Component Score change, summarized in the registry as a mean and standard deviation. In general, a mean is the arithmetic average of participant measurements. It is useful for describing the central value of a group, but it does not show the full distribution of individual outcomes. A standard deviation describes the spread of measurements around the mean; it is not the same as a confidence interval for the mean or for a treatment contrast.
What does a randomized comparison estimate?
Random allocation is intended to make the assigned groups comparable, on average, with respect to factors that could influence outcomes. A comparison by randomized assignment therefore targets the difference in outcomes between the assigned approaches, subject to the analysis and missing-data assumptions. The registry describes the primary analysis as as-randomized. It does not give further details about the statistical model, covariate adjustment, or exact contrast used.
The primary groups are ventral and dorsal. The dorsal category includes dorsal decompression with fusion and dorsal laminoplasty. Thus, the primary randomized comparison is not presented as three separate procedure-specific groups. Other outcome descriptions refer to actual treatment groups, including ventral fusion, dorsal fusion, and dorsal laminoplasty. How those groupings were used in particular secondary analyses is not reported in the registry record.
How should change scores be understood?
A change score compares a follow-up measurement with a baseline measurement for the same outcome. Comparing average changes between groups asks whether the average movement from baseline differs by assigned approach. The record specifies change from baseline for SF-36 PCS at 1 year and 2 year. It does not report the average change within either group or the difference between group changes. Without those values, the direction and size of the comparison cannot be interpreted.
In general, a confidence interval describes the uncertainty around an estimate under the statistical model and assumptions used. A narrower interval indicates greater precision than a wider interval, but interpretation also depends on what differences are meaningful for the clinical question. No confidence interval or threshold for a meaningful SF-36 PCS difference is reported in the registry record. A p value, when reported, addresses compatibility with a null hypothesis under a model; it does not by itself describe the size or clinical importance of an effect. No primary outcome p value is reported in the registry record.
What does analysis availability tell readers?
The registry gives the numbers available for primary analysis within each randomized group at each follow-up: 60/63 ventral and 95/100 dorsal at 1 year, and 51/63 ventral and 79/100 dorsal at 2 year. These are counts, not outcome estimates. Missing follow-up outcomes can affect precision and can also affect the comparison if the people without observed data differ from those with data in outcome-related ways. In general, methods such as imputation or weighting make assumptions about missing measurements. The registry record does not say whether such methods were used, why measurements were unavailable, or how sensitivity to missingness was assessed.
What do the planning illustrations mean?
The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. These assumptions describe an illustrative planning calculation, not the trial’s own design justification or an observed probability of detecting an effect. The record does not report a sample-size justification for the trial. Any sample-size illustration should be read as a planning scenario, not as observed power and not as evidence that an effect was present.
The registry record lists no analysis results. It does not report whether an interim analysis was planned or conducted, the detailed statistical model, assumptions about outcome distributions, any adjustment for baseline values, or methods for handling multiple comparisons. These aspects cannot be inferred from the randomized, parallel design or from the outcome definition. In general, model choice and analysis assumptions matter because they determine how estimates and uncertainty are calculated. The available record does not provide enough detail to assess those choices.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is specified at 1 year and 2 year, and the registry lists multiple secondary outcomes, including patient-reported measures, sagittal balance, resource use, work status, and complications. Testing or estimating many outcomes and time points can raise multiplicity concerns: when multiple hypotheses are considered, the chance of at least one apparently notable result can increase. In general, prespecified priorities and adjustment procedures can help readers interpret a family of comparisons. Whether any multiplicity adjustment was planned or used is not reported in the registry record.
The record lists 11 outcome measures and zero analysis results. It does not provide numerical findings for the primary or secondary outcomes. A detailed statistical analysis plan, the hierarchy of secondary comparisons, and any rules for selecting or adjusting analyses are not reported in the registry record. The presence of several outcomes alone does not establish how their results were analyzed.
For the primary analysis, the record says the comparison was as-randomized and gives the number available at each follow-up. It does not explain why participants were unavailable, whether missing values were imputed, whether complete-case analysis was used, or whether sensitivity analyses were performed. These details matter because the analysis depends not only on the randomized groups but also on how absent measurements are treated.
The registry record also does not specify whether analysis populations beyond the as-randomized primary analysis were defined, or how participants who received a procedure different from their assigned approach would be handled. No conclusions about protocol deviations or alternate analysis populations can be drawn from the 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 |
|---|---|---|---|
| Ventral | 14 | 66 | 21.2% |
| Dorsal Decompression With Fusion | 15 | 69 | 21.7% |
| Dorsal Laminoplasty | 2 | 28 | 7.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ventral | 1 of 66 |
| Dorsal Decompression With Fusion | 1 of 69 |
| Dorsal Laminoplasty | 2 of 28 |
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 |
|---|---|
| Ventral | 18 of 66 |
| Dorsal Decompression With Fusion | 5 of 69 |
| Dorsal Laminoplasty | 1 of 28 |
Most frequent serious adverse event terms
| Event term | Organ system | Ventral | Dorsal Decompression With Fusion | Dorsal Laminoplasty |
|---|---|---|---|---|
| Prolonged dysphagia | Musculoskeletal and connective tissue disorders | 9 of 66 | 0 of 69 | 0 of 28 |
| Motor radiculopathy (ongoing at 3 months) | Musculoskeletal and connective tissue disorders | 1 of 66 | 8 of 69 | 0 of 28 |
| Reoperations | Surgical and medical procedures | 4 of 66 | 4 of 69 | 0 of 28 |
| Cervical (C5) paresis (readmissions within 30 days) | Nervous system disorders | 0 of 66 | 2 of 69 | 0 of 28 |
| Spinal cord injury | Nervous system disorders | 0 of 66 | 0 of 69 | 1 of 28 |
| Deep vein thrombosis | Vascular disorders | 0 of 66 | 1 of 69 | 0 of 28 |
| Delayed wound healing | Skin and subcutaneous tissue disorders | 0 of 66 | 1 of 69 | 0 of 28 |
| Pulmonary Embolism (readmissions within 30 days) | Vascular disorders | 0 of 66 | 1 of 69 | 0 of 28 |
| Ileus (readmissions within 30 days) | Gastrointestinal disorders | 0 of 66 | 1 of 69 | 0 of 28 |
| Uncontrolled neck pain (readmissions within 30 days) | Musculoskeletal and connective tissue disorders | 0 of 66 | 1 of 69 | 0 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ventral | Dorsal Decompression With Fusion | Dorsal Laminoplasty |
|---|---|---|---|---|
| Dysphagia | Musculoskeletal and connective tissue disorders | 18 of 66 | 0 of 69 | 0 of 28 |
| Infection | General disorders | 0 of 66 | 2 of 69 | 1 of 28 |
| Motor radiculopathy | Musculoskeletal and connective tissue disorders | 0 of 66 | 2 of 69 | 0 of 28 |
| Delayed wound healing | General disorders | 0 of 66 | 1 of 69 | 0 of 28 |
Serious events with the highest arm-level rate: prolonged dysphagia (13.6%), motor radiculopathy (ongoing at 3 months) (11.6%), reoperations (6.1%), spinal cord injury (3.6%), fever (readmissions within 30 days) (3.6%).
The safety information separates serious adverse events, other adverse events, and deaths by listed treatment group. For Ventral, the record lists 66 at risk for serious events and 14 affected; for Dorsal Decompression With Fusion, 69 at risk and 15 affected; for Dorsal Laminoplasty, 28 at risk and 2 affected. For other adverse events, the corresponding at-risk and affected counts are 66 and 18, 69 and 5, and 28 and 1. The listed deaths are 1, 1, and 2, respectively. These are group-specific counts; they are not a randomized comparison of risks unless the analysis and assignment basis are specified.
The registry also lists serious-event terms with percentages: prolonged dysphagia, 13.6%; motor radiculopathy (ongoing at 3 months), 11.6%; reoperations, 6.1%; spinal cord injury, 3.6%; fever (readmissions within 30 days), 3.6%; and cervical (C5) paresis (readmissions within 30 days), 2.9%. The record does not provide further detail on event timing, recurrence, attribution, or uncertainty for these percentages. Counts of participants affected should not automatically be read as counts of separate event episodes, since one participant may experience more than one event. The figures describe reported safety information and do not, by themselves, establish causal differences between procedures.
12. What the Result Does, and Does Not, Mean
The registry record defines a randomized comparison of ventral and dorsal surgery and identifies change in SF-36 PCS at 1 year and 2 year as the primary outcome. It also reports the numbers available for analysis at those times. Those details help establish what question the trial was designed to address and how much follow-up was available for the stated primary analysis.
However, numerical primary outcome estimates are not reported in the registry record. There is no reported group mean change, between-group contrast, standard deviation, confidence interval, or p value. The record therefore does not show whether the groups’ average changes differed, how large any difference was, or how precisely it was estimated. The stated hypothesis about superior 1-year outcome is not evidence that the hypothesis was confirmed.
The listed secondary outcomes broaden the questions beyond physical health scores, including disability, quality of life, spinal cord dysfunction, sagittal balance, resource use, work status, and complications. Their results are not reported in the registry record. Nor does the record establish a separate primary comparison among all three procedures: the primary analysis groups dorsal fusion and laminoplasty together.
In general, a randomized trial can inform a treatment comparison when its results, analysis methods, and uncertainty are reported. The design alone does not tell readers what the outcome estimates were. Counts available for analysis are useful context, but they are not a substitute for outcome measurements or a missing-data assessment. Safety counts also require context about event definitions, follow-up, and analysis before being interpreted as comparative effects.
The record supports a description of the clinical question, randomized design, endpoint, follow-up availability, and listed adverse-event counts. It does not support a conclusion about which approach produced a better SF-36 PCS outcome, whether either approach improved scores, or whether the approaches differed in secondary outcomes or safety. Those results are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial addresses a comparison between surgical approaches for cervical spondylotic myelopathy using a patient-reported physical health measure. Statistically, its central question is not simply whether scores change after surgery, but whether the average change differs between randomized ventral and dorsal groups at the specified follow-up times. That distinction matters: change within a group and a difference between groups answer different questions.
The endpoint is measured at more than one follow-up time, while the dorsal category contains two procedures. These design features make clear outcome definitions and transparent analysis reporting especially important. Readers need to know which group contrast is primary, how time points are handled, and whether secondary procedure-specific comparisons are exploratory or prespecified. Those analysis details are not reported in the registry record.
The trial also illustrates why participant counts alone are not enough to judge a result. Availability at follow-up affects how many outcomes contribute to an estimate, while the outcome values and their variability determine the estimated contrast and its precision. Without reported effect estimates and uncertainty, neither the magnitude nor the reliability of the primary comparison can be assessed.
The registry’s safety counts and broad set of secondary outcomes further show why distinct outcome types should not be collapsed into a single claim. A patient-reported score, an adverse event, resource use, and work status each measure different aspects of the study question. Their estimates require appropriate definitions and analysis, and the registry record does not report numerical findings for these outcomes.
From a statistical perspective, the record is informative about the trial’s intended comparison but incomplete for evaluating its results. This distinction helps prevent a stated hypothesis or randomized design from being mistaken for evidence of a particular outcome.
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.
A central limitation for interpretation is that the registry record does not report numerical results for the primary endpoint, despite describing the endpoint and the number of participants available for analysis. Without group means, contrasts, and measures of uncertainty, the effect and its precision cannot be assessed. The record also does not report numerical results for the listed secondary outcomes.
The primary comparison combines dorsal decompression with fusion and dorsal laminoplasty. As a result, the primary question does not provide a separate reported randomized estimate for each dorsal procedure. Although secondary descriptions distinguish actual treatment groups, their analyses and numerical results are not reported in the registry record.
Follow-up availability is reported for each primary outcome time point, but reasons for missing measurements and methods for handling them are not reported. This limits assessment of whether the analyzed participants represent the randomized groups. The record also does not specify the statistical model, covariate adjustment, outcome-distribution assumptions, or sensitivity analyses.
Several outcome domains and follow-up times are listed, but multiplicity procedures and the order or priority of secondary comparisons are not reported. The registry record does not provide a sample-size justification, an interim-analysis plan, or detailed eligibility and protocol information in the registry record for this analysis. These gaps limit evaluation of the design rationale and the full analysis strategy.
Finally, the safety information includes counts and selected serious-event terms, but the record does not provide additional detail about event attribution, timing, recurrence, or comparative uncertainty. Counts alone cannot establish that one procedure caused more or fewer events than another.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cervical Spondylotic Myelopathy Surgical Trial — NCT02076113.
- Registry record last updated 2026-02-20; status last verified 2026-02.
- Results first posted 2021-07-20.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The Cervical Spondylotic Myelopathy Surgical Trial is a randomized, parallel-group study with no masking, sponsored by Lahey Clinic. The registry lists enrollment of 269, a start date of 2014-04-01, primary completion on 2018-03-30, and a status of active, not recruiting. The procedures are ventral decompression with fusion, dorsal decompression with fusion, and dorsal laminoplasty.
The primary outcome is change in SF-36 Physical Component Score from baseline at 1 year and 2 year. The primary analysis is described as as-randomized, comparing ventral with dorsal surgery. Analysis availability is reported for both follow-up times, but numerical primary outcome estimates and secondary outcome results are not reported in the registry record. The record also lists serious and other adverse-event counts by treatment group, along with selected serious-event terms.