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 Post-Market Evaluation of the Rotation Medical Rotator Cuff System (NCT02200939), a non-randomized na study. The primary outcome is Change in Tendon Thickness.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02200939 |
| Phase | NA |
| Condition | Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 148 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Smith & Nephew, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants had partial-thickness or full-thickness supraspinatus tendon tears and received surgical treatment. The registry describes intermediate or high partial-thickness tears, very small full-thickness tears, and medium or large full-thickness tears. The primary endpoint population is participants with either tear type who provided data at the specified measurement times.
Intervention
The intervention was the Rotation Medical Bioinductive Implant. For the partial-thickness tear group, the implant was used as a standalone device. The registry describes the implant as adjunctive to surgical repair for the medium or large full-thickness tear group.
Comparator
The record describes two parallel, non-randomized groups defined by tear type and surgical approach. It does not describe a like-for-like control group receiving no implant or another treatment. The groups therefore should not be interpreted as randomized treatment arms for estimating a causal effect.
Primary question
The primary question concerns how mean supraspinatus tendon thickness at the implant site changed from pre-operative baseline to 3 months, 1 year, and 2 years. MRI measurements included the tendon and any newly induced tissue at the implant site. The registry describes comparisons by tear type and size; numerical estimates of change and their precision are not reported in the registry record.
The study’s stated purpose was to evaluate bioinduction of new tissue and tendon healing after implantation, either as a standalone device or alongside surgical repair. The endpoint operationalizes one aspect of that purpose through imaging-based thickness measurements. It is not, by itself, a direct measure of symptoms, function, healing durability, or the relative benefit of the implant compared with an alternative. The registry also lists shoulder scores, procedural measures, and recovery outcomes as secondary outcomes, but their numerical results are not reported in the registry record.
3. Trial Design
This was a completed, parallel-group, non-randomized study of the Rotation Medical Rotator Cuff System. The registry lists an enrollment of 148 and identifies Smith & Nephew, Inc. as the sponsor. The study began on 2014-08-20, reached primary completion on 2020-11-24, and is recorded as completed. Its phase is listed as not applicable.
The groups were distinguished by tear characteristics and use of the implant during surgery. Participants with intermediate or high partial-thickness tears, or very small full-thickness tears, were surgically treated with the bioinductive implant. Participants with medium or large full-thickness tears were surgically treated with the implant adjunctive to surgical repair. This is not a randomized allocation: the groups differ in the tear categories and treatment approaches assigned to them. Their outcomes therefore cannot be treated as a like-for-like comparison of implant versus no implant.
The registry records no masking. It lists the bioinductive implant and surgical repair as device interventions. The primary measurement was tendon thickness assessed by MRI at the implant site, including tendon and newly induced tissue, at 3 months, 1 year, and 2 years relative to pre-operative baseline. The primary analysis population is described as participants with partial-thickness or full-thickness tears who provided data at the specified time frames.
Secondary outcomes include device implant time, technical success, American Shoulder and Elbow Society and Constant-Murley scores, and measures of recovery such as sling time, rehabilitation time, return to work, and return to normal daily activities. The registry lists 13 outcome measures and 0 analyses. Further details about recruitment, treatment selection, follow-up procedures, or the statistical analysis plan are not 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.
Overall Study
| Stage | Partial-Thickness Tear | Full Thickness Tear |
|---|---|---|
| STARTED | 33 | 115 |
| COMPLETED | 31 | 104 |
| NOT COMPLETED | 2 | 11 |
Reasons for not completing this period:
| Reason | Partial-Thickness Tear | Full Thickness Tear |
|---|---|---|
| Participant withdrew consent | 0 | 1 |
| Lost to Follow-up | 2 | 9 |
| Subject moved out of town and unable to make it back to study | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants with partial-thickness or full thickness tears that provided data at the specified time frames.
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: Number of participants after implantation of the REGENETEN Bioinductive Implant for partial-thickness tear (PTT) or full-thickness tear (FTT) that provided data.
| Characteristic | Unit | Partial-Thickness Tear | Full Thickness Tear | Total |
|---|---|---|---|---|
| Participants analysed | 33 | 115 | 148 | |
| Age, Continuous | years | 54.60 (SD 10.13) | 60.40 (SD 8.01) | 59.10 (SD 8.83) |
| Sex: Female, Male: Female | Participants | 14 | 39 | 53 |
| Sex: Female, Male: Male | Participants | 19 | 76 | 95 |
| Race/Ethnicity, Customized: Ethnicity – Caucasian | Participants | 33 | 100 | 133 |
| Race/Ethnicity, Customized: Ethnicity – Asian | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Ethnicity – Hispanic | Participants | 0 | 5 | 5 |
| Race/Ethnicity, Customized: Ethnicity – African American | Participants | 0 | 9 | 9 |
| Region of Enrollment: United States | participants | 33 | 115 | 148 |
| Hand Dominance: Right | Participants | 29 | 103 | 132 |
| Hand Dominance: Left | Participants | 4 | 12 | 16 |
| Affected Shoulder: Right | Participants | 17 | 78 | 95 |
| Affected Shoulder: Left | Participants | 16 | 37 | 53 |
| Smoking Habit: Never Smoked | Participants | 20 | 81 | 101 |
| Smoking Habit: Former Smoker | Participants | 12 | 31 | 43 |
| Smoking Habit: Current Smoker | Participants | 1 | 3 | 4 |
| Employment Status: Currently employed (working for pay) | Participants | 22 | 83 | 105 |
| Employment Status: Currently unemployed (not working for pay) | Participants | 11 | 32 | 43 |
| Tear Size: Partial-Thickness ONLY: Grade 1: Low (< 3 mm) | Participants | 0 | 0 | 0 |
| Tear Size: Partial-Thickness ONLY: Grade 2: Intermediate (3-6 mm) | Participants | 12 | 0 | 12 |
| Tear Size: Partial-Thickness ONLY: Grade 3: High (> 6 mm) | Participants | 21 | 0 | 21 |
| Tear Size: Full Thickness ONLY: Small (< 1 cm) | Participants | 0 | 0 | 0 |
| Tear Size: Full Thickness ONLY: Medium (1-3 cm) | Participants | 0 | 66 | 66 |
| Tear Size: Full Thickness ONLY: Large (3-5 cm) | Participants | 0 | 49 | 49 |
| Tear Size: Full Thickness ONLY: Massive (> 5 cm) | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Tendon Thickness, measured over Pre-operatively (baseline) to 3 month, 1 year, and 2 year.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | millimeters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in supraspinatus tendon thickness from the pre-operative baseline to 3 months, 1 year, and 2 years. The record describes MRI measurements of total tendon thickness and any newly induced tissue at the implant site. Results are expressed as a mean change with a standard deviation, and the registry describes analyses by partial-thickness tear size, intermediate or high, and full-thickness tear size, medium or large.
Thickness is an imaging-based continuous measure. Reporting a mean change gives an average direction and magnitude of change in the measured tissue for participants with data at the relevant time. The standard deviation describes variability among those measurements; it does not describe how precisely the group mean was estimated. A confidence interval, if reported, would address the precision of the mean estimate, but no confidence interval is reported in the registry record.
This measure was selected to assess tissue thickness at the implant site in relation to the study’s stated interest in bioinduction and tendon healing. It does not alone establish the quality or mechanical strength of tissue, nor does it directly establish changes in pain, function, or recovery. The numerical mean changes and standard deviations at the stated time points are not reported in the registry record, so the magnitude and precision of the endpoint findings cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a clinical evaluation of an implant used in two different surgical contexts: as a standalone device for the specified partial-thickness and very small full-thickness tears, and as an adjunct to surgical repair for medium or large full-thickness tears. That distinction is important. The groups are not interchangeable, and the non-randomized design does not support interpreting differences between them as an unbiased treatment contrast.
The primary endpoint is a mean change in tendon thickness measured by MRI from baseline to follow-up. The endpoint description identifies measurements at 3 months, 1 year, and 2 years and specifies that analyses were organized by tear type and size. However, numerical endpoint results, including means and standard deviations, are not reported in the registry record. The record therefore does not establish how much thickness changed, whether estimates varied across tear categories or time points, or how precisely any mean change was estimated.
Without numerical endpoint estimates or uncertainty intervals, readers cannot judge the scale of the reported changes or distinguish a precise estimate from one with substantial uncertainty. Even if a mean change were available, interpretation would require attention to the variability of individual measurements, the number of participants contributing data at each time, and the possibility that follow-up data availability differed over time. Those details are not reported in the registry record.
The registry lists secondary measures of procedure, shoulder function, and recovery, but numerical results for these outcomes are not reported in the registry record. The available safety counts describe serious and other adverse events in the two groups, but they do not supply a randomized comparison. The serious-event counts are 1 among 33 at risk in the partial-thickness group and 12 among 115 at risk in the full-thickness group; other adverse-event counts are 7 among 33 and 10 among 115, respectively. These are descriptive group-specific figures, not estimates of comparative treatment effects.
The study’s stated purpose was to evaluate tissue induction and tendon healing. The registry entries the measurement approach, but the absence of numerical primary results means the endpoint’s observed pattern and precision cannot be interpreted. No conclusion about effectiveness or comparative benefit follows from the design description or adverse-event counts alone. The record also does not report the statistical plan, missing-data procedures, or analysis populations beyond the broad description of participants contributing data at specified time frames.
9. Statistical Methods Explained
What does a mean change represent?
For a continuous outcome such as tendon thickness, a mean change summarizes the average difference between measurements at follow-up and baseline among the participants included in that analysis. It is a group summary, not a description of every participant’s experience. Individual changes can vary around the mean, which is why the registry describes reporting the mean together with a standard deviation.
In general, a standard deviation describes the spread of individual measurements around a group mean. It is not the same as a standard error or confidence interval. A confidence interval is a range of values compatible with the data under the assumptions of the analysis and conveys uncertainty about an estimated quantity, such as a group mean. It is not reported for the primary endpoint in the registry record. Because the numerical means and standard deviations are also not reported there, neither the size of the average change nor its variability can be evaluated from the record.
Why distinguish the groups?
The endpoint description separates partial-thickness tears by intermediate or high size and full-thickness tears by medium or large size. The treatment context also differs: the implant is described as a standalone device for one group and as adjunctive to repair for the other. These distinctions matter statistically because pooled summaries could obscure variation across clinically defined groups, while direct comparisons across groups could mix the effects of tear characteristics and treatment approach.
In general, randomization helps balance measured and unmeasured participant characteristics between treatment groups on average. Here, allocation is non-randomized, and the registry explicitly identifies the arms as not being a like-for-like control comparison. Accordingly, a difference between group outcomes, if one were reported, would not by itself isolate the effect of the implant. The record does not report adjusted comparisons or a method for controlling confounding.
What does repeated follow-up imply?
The primary endpoint has follow-up measurements at 3 months, 1 year, and 2 years relative to pre-operative baseline. Repeated observations can describe how measurements vary over time, but the interpretation depends on who contributed data at each time and how within-participant correlation was handled. Measurements from the same participant are generally related rather than independent. In general, an analysis of repeated measures should account for that dependence if it models more than one time point together.
The registry gives a broad endpoint population description: participants with either tear type who provided data at the specified time frames. It does not report the number contributing at each time point, whether the same participants contributed at all follow-ups, or the statistical model used. The primary results and analysis details needed to evaluate those issues are not reported in the registry record.
What can a planning calculation tell readers?
In general, sample-size calculations describe the amount of information a future study might need under stated assumptions. They are planning illustrations, not observed power and not evidence that an analysis had a particular probability of detecting an effect. The planning assumptions described for this analysis use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such calculations are not the trial’s own design justification.
Sample-size illustrations depend on assumptions about the effect to detect and the variability of the outcome. If the assumed effect is smaller, a planning calculation would generally require more information to detect it under the same other assumptions; this is a general statistical relationship, not a result about this study. The registry record does not report a sample-size justification for the trial, and these planning assumptions should not be interpreted as documenting the original design or the study’s observed power.
Why is variability important?
Continuous measurements can have more variability than a simple mean-and-standard-deviation summary fully conveys. In general, when data are more dispersed than an analysis assumes, standard errors and confidence intervals based on an inadequate model may be too small, making results appear more precise than they are. Methods that account for over-dispersion or other departures from a model can be appropriate when supported by the data and design. The registry does not report a distributional assessment, an over-dispersion adjustment, or other model diagnostics for tendon thickness.
For this study, the record’s description of the endpoint and summary statistic is not a substitute for the analysis details. The specific model, handling of repeated measurements, covariate adjustment, precision estimates, and any sensitivity analyses are not reported in the registry record. Those omissions limit independent assessment of the statistical approach, separate from the non-randomized design and the absence of numerical primary results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures and 0 analyses. The primary endpoint itself includes measurements at 3 months, 1 year, and 2 years and separates results by tear type and size. Considering multiple outcomes, time points, or subgroups can increase the chance of highlighting a result that appears unusual by chance. In general, a statistical plan may address this through a prespecified primary comparison, a hierarchy of outcomes, or an adjustment for multiple testing. The registry record does not report a multiplicity strategy or enough analysis detail to determine how these issues were handled.
The record describes the primary population as participants with partial-thickness or full-thickness tears who provided data at the specified time frames. It does not report a detailed analysis-population definition, such as whether all enrolled participants were included in each analysis or how deviations from the planned treatment were handled. The number with endpoint data at each time point and within each tear-size category is not reported in the registry record.
Missing-data methods can affect repeated-measure results if the availability of measurements is related to participant characteristics or outcomes. In general, complete-case analyses and model-based methods rely on different assumptions about missing observations. The registry record does not report the amount or pattern of missing endpoint data, reasons for missingness, imputation procedures, or sensitivity analyses. It is therefore not possible to assess how missing measurements may have affected the reported endpoint; numerical endpoint results are not reported in the registry record in any case.
Neither the inferential statistical plan nor any adjustment for multiple outcomes is reported. No p-values, confidence intervals, or analysis-specific population counts for the primary endpoint are 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 |
|---|---|---|---|
| Partial-Thickness Tear | 1 | 33 | 3.0% |
| Full Thickness Tear | 12 | 115 | 10.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Partial-Thickness Tear | 0 of 33 |
| Full Thickness Tear | 0 of 115 |
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 |
|---|---|
| Partial-Thickness Tear | 7 of 33 |
| Full Thickness Tear | 10 of 115 |
Most frequent serious adverse event terms
| Event term | Organ system | Partial-Thickness Tear | Full Thickness Tear |
|---|---|---|---|
| Index shoulder recurrent rotator cuff tear | Musculoskeletal and connective tissue disorders | 0 of 33 | 5 of 115 |
| Cardiac Ablation | Cardiac disorders | 1 of 33 | 0 of 115 |
| Index shoulder new rotator cuff tear and lack of healing | Musculoskeletal and connective tissue disorders | 0 of 33 | 1 of 115 |
| Contralateral shoulder distal clavical excision, RCT debridement of degenerative labrum & bursectomy | Musculoskeletal and connective tissue disorders | 0 of 33 | 1 of 115 |
| Index shoulder recurrent full thickness rotator cuff tear | Musculoskeletal and connective tissue disorders | 0 of 33 | 1 of 115 |
| Foot Pain | Injury, poisoning and procedural complications | 0 of 33 | 1 of 115 |
| Contralateral Rotator Cuff Tear | Musculoskeletal and connective tissue disorders | 0 of 33 | 1 of 115 |
| Index shoulder swelling and drainage | Product Issues | 0 of 33 | 1 of 115 |
| Index shoulder pain, inflammatory changes, and osteopenia in the region of the greater tuberosity | Product Issues | 0 of 33 | 1 of 115 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Partial-Thickness Tear | Full Thickness Tear |
|---|---|---|---|
| Index shoulder pain | Musculoskeletal and connective tissue disorders | 1 of 33 | 1 of 115 |
| Midthoracic pain; slow heartbeat; R clavicle nondisplaced fracture w/fibrous union & bone formation | Cardiac disorders | 0 of 33 | 1 of 115 |
| Index shoulder pain and stiffness | Musculoskeletal and connective tissue disorders | 1 of 33 | 0 of 115 |
| Leg trauma | Injury, poisoning and procedural complications | 1 of 33 | 0 of 115 |
| Contralateral shoulder ache | Musculoskeletal and connective tissue disorders | 0 of 33 | 1 of 115 |
| Contralateral shoulder pain | Musculoskeletal and connective tissue disorders | 0 of 33 | 1 of 115 |
| Index shoulder subacromial fluid collection/inflammation | Product Issues | 1 of 33 | 0 of 115 |
| Index shoulder pain and stiffness | Product Issues | 1 of 33 | 0 of 115 |
| Index shoulder bicep tendonitis | Injury, poisoning and procedural complications | 1 of 33 | 0 of 115 |
| Index shoulder rash | Injury, poisoning and procedural complications | 1 of 33 | 0 of 115 |
Serious events with the highest arm-level rate: index shoulder recurrent rotator cuff tear (4.3%), cardiac ablation (3.0%), index shoulder new rotator cuff tear and lack of healing (0.9%), contralateral shoulder distal clavical excision, rct debridement of degenerative labrum & bursectomy (0.9%), index shoulder recurrent full thickness rotator cuff tear (0.9%).
The registry lists serious and other adverse-event counts separately for the partial-thickness and full-thickness groups. For serious adverse events, it records 1 affected among 33 at risk in the partial-thickness group and 12 affected among 115 at risk in the full-thickness group. For other adverse events, it records 7 affected among 33 at risk and 10 affected among 115 at risk, respectively. Deaths are listed as 0 in each group.
These figures are descriptive counts within groups. Because the study was non-randomized and the groups differ in tear category and surgical approach, the counts do not form a controlled comparison of treatment-related risk. The registry does not report a statistical comparison or uncertainty interval for these safety figures. The counts should not be converted into a causal claim about the implant or used to compare the groups as if their participants had been randomly assigned.
The registry also lists serious-event terms, including index shoulder recurrent rotator cuff tear at 4.3%, cardiac ablation at 3.0%, and several terms at 0.9%. These listed percentages are not accompanied by further details on event timing, relatedness, or the method used to calculate them. A full interpretation of seriousness, attribution, and clinical context is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record documents a completed study evaluating the Rotation Medical Bioinductive Implant in surgical treatment of supraspinatus tendon tears. It defines an imaging-based primary endpoint: mean change in tendon thickness from pre-operative baseline to follow-up, with measurement of tendon and newly induced tissue at the implant site. It also distinguishes the surgical context for partial-thickness and full-thickness tear groups.
What the record does not establish is the magnitude or precision of the primary endpoint findings. Numerical mean changes and standard deviations are not reported in the registry record. Without them, readers cannot determine the direction or size of observed change, assess variability, or examine whether the pattern differed by tear size or follow-up time. Numerical results for the listed shoulder-function and recovery outcomes are also not reported in the registry record.
The study design further limits interpretation. Allocation was non-randomized, and the two groups were defined by different tear characteristics and different surgical approaches. Any difference between groups would therefore not, on its own, estimate the effect of the implant relative to a comparable control condition. The record does not report an adjusted comparative analysis that might address differences between groups.
The adverse-event counts provide a descriptive account of recorded events in each group, but not a controlled estimate of comparative safety. The registry does not report the inferential analysis, event attribution, or uncertainty around those counts. These limitations do not erase the descriptive value of the study; they define the boundary between what the record documents and what it cannot establish.
In general, an imaging endpoint can contribute evidence about a biological or structural measurement, while patient-reported scores, function, and recovery outcomes address other aspects of care. The registry lists such secondary measures, but their results are not reported in the registry record. The findings therefore cannot be used to make a complete assessment of clinical outcomes, comparative effectiveness, or safety.
13. Why This Trial Matters Statistically
This trial is statistically informative in part because it makes clear how study design shapes the meaning of an outcome. A parallel structure does not itself create a valid treatment comparison: the allocation is non-randomized, and the groups differ in tear categories and the use of the implant alongside surgical repair. Statistical interpretation must therefore separate within-group description from causal comparison.
The primary endpoint also illustrates the distinction between a defined measurement and a reported result. The registry specifies MRI-based tendon thickness, a mean change, a standard deviation, and follow-up at 3 months, 1 year, and 2 years. Those details identify what was intended to be measured. However, the numerical estimates and their uncertainty are not reported in the registry record. Endpoint specification alone cannot show the observed pattern or its precision.
Repeated follow-up and multiple tear categories raise familiar analysis questions: which participants contributed at each time, how correlated measurements were handled, and whether outcomes or subgroup results were prioritized. These details are important because selective availability or multiple comparisons can affect interpretation. The registry does not report the analysis plan, missing-data procedures, or multiplicity approach, so those questions remain unresolved.
The safety counts demonstrate why group-specific descriptive reporting should not be confused with comparative risk estimation. Counts can be useful context, but a non-randomized design and absent inferential details do not support attributing differences to treatment. Overall, the record offers a clear outline of the clinical question and endpoint but leaves substantial uncertainty about the numerical results and statistical analysis.
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 most consequential limitation for statistical interpretation is that numerical results for the primary tendon-thickness endpoint are not reported in the registry record. The described mean, standard deviation, and MRI time points do not reveal the observed amount of change or its precision. Numerical results for the listed secondary outcomes are also not reported in the registry record.
Allocation was non-randomized, and the groups represent different tear characteristics and surgical approaches. As a result, they are not a like-for-like control comparison. The record does not report a comparison group receiving no implant or an alternative treatment, nor does it report an adjusted analysis to account for differences between groups. Causal interpretation is therefore limited.
The endpoint population is described as participants who provided data at specified time frames, but the registry does not report the number contributing at each follow-up, the extent or reasons for missing data, or methods used to address missingness. The analysis model, treatment of repeated observations, covariate adjustment, multiplicity strategy, and sensitivity analyses are also not reported in the registry record.
The safety summary contains group-specific counts and selected serious-event terms, but the record does not report inferential comparisons, uncertainty intervals, event attribution, or further details of the percentage calculations. Enrollment is recorded as 148, but the relationship between that enrollment figure and the endpoint-specific analysis populations is not described. Together, these limitations prevent a detailed assessment of endpoint precision, comparative effects, and the robustness of the analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Post-Market Evaluation of the Rotation Medical Rotator Cuff System — NCT02200939.
- Registry record last updated 2022-03-02; status last verified 2022-02.
- Results first posted 2022-03-02.
- 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
NCT02200939 is a completed, parallel, non-randomized study of the Rotation Medical Bioinductive Implant for supraspinatus tendon tears. The registry records enrollment of 148 and identifies Smith & Nephew, Inc. as the sponsor. The implant was used as a standalone device for the specified partial-thickness and very small full-thickness tears, and adjunctively to surgical repair for medium or large full-thickness tears.
The primary endpoint was mean change in tendon thickness measured by MRI from pre-operative baseline to 3 months, 1 year, and 2 years. The registry lists 13 outcome measures and 0 analyses. Numerical primary and secondary outcome results, the statistical analysis plan, and missing-data methods are not reported in the registry record. The design does not provide a like-for-like randomized control comparison; safety figures are descriptive group counts.