PMCF Study on PEEK Suture Anchors for Shoulder Indications: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for PMCF Study on PEEK Suture Anchors for Shoulder Indications (NCT03826667), a registered phase not stated study. The primary outcome is Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention.

2. Clinical Question

3. Trial Design

This is a completed post-market clinical follow-up study of PEEK suture anchors for shoulder indications, sponsored by Smith & Nephew, Inc. The registry lists a start date of 2019-02-14, primary completion on 2019-08-28, and enrollment of 464. It describes the intervention as a device, rather than a drug or a stated surgical technique comparison.

The registry record does not state that participants were randomly assigned, and allocation is not stated. The device groups reported for adverse events are not a like-for-like control comparison. Their counts should be understood as separate device-specific descriptions, not as evidence from randomized treatment arms. The record says that some participants received multiple suture anchors and that data were analyzed independently according to the specific device implanted. Thus, device-level reporting should not automatically be treated as a count of unique participants across all groups.

The primary endpoint is a participant count at six months after intervention. Secondary outcomes include clinical success over twelve months, pain measured by the Visual Analog Scale, a count of participants with a full functional arc of range of motion, and range of motion. The registry lists five outcome measures and zero analyses. The primary endpoint is described, but its result is not reported in the registry record.

Further design details—including eligibility criteria, recruitment procedures, follow-up procedures, allocation methods, and a statistical analysis plan—are not reported in the registry record. The record does not establish why the enrollment target was chosen or whether any interim analysis was planned. The study is marked completed, but completion status alone does not supply the missing endpoint findings or explain how participants were handled in each analysis.

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: It was intended to enroll participants for 8 PEEK suture anchor devices; however, no participants were enrolled for the BIORAPTOR™ Knotless Suture Anchors, resulting in 7 suture anchor groups being analyzed. A total of 464 participants were enrolled in the study and 467 joints were observed. Multiple devices were implanted in 124 participants.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.

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: Participants enrolled in the study who had previously undergone shoulder repair using PEEK suture anchors (i.e., retrospective data). The type(s) of PEEK anchor used during surgery was surgeon decision on a case by case basis. Multiple anchor types could be used in one surgery if required. 124 participants had multiple devices implanted. Participants with bilateral surgeries had both surgeries recorded independently. Device data analyzed individually dependent on unique suture anchor implanted.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention, measured over 6 months.

The primary endpoint is the number of participants with clinical success of the study devices in the shoulder over six months after intervention. It is a binary outcome at the participant level: a participant either meets the stated success criteria or does not. The reported measure is a count, not a percentage or a comparison between treatment groups.

Clinical success was assessed by the surgeon. The definition describes shoulder repairs without signs of device failure and/or re-intervention, and specifies three criteria: no inflammatory or allergic response; no device-related adverse event; and no device deficiency leading to revision surgery on the index shoulder. These criteria make the endpoint a composite: success depends on meeting the stated conditions rather than on a single symptom or measurement.

As a general statistical concept, a composite endpoint can summarize several clinically distinct events in one outcome. It can also make interpretation dependent on the exact definition and on which component occurs. The stated endpoint combines event-related criteria with a surgeon assessment. The registry does not report how each component contributed to the primary result, nor does it report the number meeting the composite definition at six months. Consequently, the endpoint’s definition can be described, but its observed frequency cannot be interpreted from the registry record.

The population note says the number analyzed at the specified time frame represents participants with retrospective data for the identified PEEK Suture Anchor. It also notes that a participant may have multiple anchors and that device-specific data were analyzed independently. This makes clear why the endpoint’s analysis unit and device attribution matter when interpreting any eventual count.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a binary primary outcome: whether a participant met the clinical-success definition at six months. In general, binary outcomes classify each observation into one of two categories, such as success or not success. A participant count is a numerator-like quantity, but without the corresponding analyzed denominator it does not describe the proportion meeting the outcome. The primary result and its analysis are not reported in the registry record.

What does the endpoint count?

The endpoint is defined at the participant level, while the record also explains that some participants received multiple anchors and that data were analyzed independently according to the specific implanted device. Those details make attribution important: a participant’s retrospective data relate to an identified device, and one participant can be relevant to multiple device records. General statistical reasoning cautions against assuming that device-level observations are always independent when a participant contributes more than one device. The registry does not report a model or adjustment for such dependence.

The success definition combines several conditions: absence of an inflammatory or allergic response, absence of a device-related adverse event, and absence of a device deficiency leading to revision surgery on the index shoulder. It also describes success as repair without signs of device failure and/or re-intervention as assessed by the surgeon. For a composite outcome, the overall classification depends on the specified component rules. The record does not report component-specific primary endpoint results, adjudication procedures, or how disagreements in assessment were handled.

How should the adverse-event counts be read?

The serious and other adverse-event figures are presented as affected participants and participants at risk for each device group. In general, a count gives the number of recorded events or affected participants, while the at-risk count indicates the group size associated with that reporting category. Counts alone do not quantify comparative effects. Their interpretation also depends on how events were defined, collected, and attributed, and on the duration and completeness of follow-up. The registry information does not provide those additional methods.

General statistical comparisons require a suitable design and a clearly defined estimand: the precise quantity a comparison is intended to estimate. Random allocation can support comparisons by balancing prognostic factors on average, but allocation is not stated in this record. The record explicitly cautions that the device groups are not a like-for-like control comparison. Accordingly, group counts should be described, not converted into a causal claim or an unadjusted device ranking.

What can sample-size planning say?

General sample-size calculations describe the enrollment needed under specified assumptions to detect a chosen effect with a chosen error rate and power. The record’s planning assumptions describe 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. These are planning conventions, not evidence that the trial used that design. The record does not report the trial’s own sample-size justification, and no calculated sample-size values are available in the registry information.

Any sample-size figures based on those assumptions are planning illustrations, not observed power. Observed power is not a substitute for an estimate and its uncertainty after a study is complete. In particular, it would be inappropriate to infer power from the enrollment count alone. The registry does not report an observed primary effect on which to base a trial-specific interpretation of such illustrations.

What uncertainty measures are missing?

A confidence interval is a general way to communicate the precision of an estimate under a specified statistical method. A narrow interval indicates greater precision under that method, while a wide interval indicates more uncertainty. A p-value, when used, addresses compatibility of the data with a specified null hypothesis under model assumptions; it is not an estimate of effect size or clinical importance. Neither a primary endpoint confidence interval nor a primary test result is reported in the registry record.

For a binary endpoint, the analysis method would ordinarily need to specify how the success count and denominator are defined and how missing observations are handled. If comparisons were intended, the method would also need to address the comparison structure and any relevant dependence among observations. None of those statistical details is reported. The record’s zero analyses means that no statistical analysis results are posted in the information described; it does not imply that no data were collected.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and secondary outcomes covering twelve-month clinical success, Visual Analog Scale pain, a count of participants with a full functional arc of range of motion, and range of motion. It lists five outcome measures and zero analyses. No multiplicity plan is reported in the registry record. As a general matter, evaluating several outcomes can increase the chance of a nominally notable result arising by chance if many tests are conducted; methods for addressing that issue depend on the prespecified analysis plan. The record does not state whether outcomes were prioritized, adjusted, or treated as exploratory.

Missing-data methods are not reported. The record does not describe how participants without six-month data were treated, whether incomplete follow-up occurred, or whether any imputation or sensitivity analysis was used. The population description notes that participants analyzed at a specified time frame had retrospective data for the identified device, but it does not explain how that population was formed or how absent data were handled.

The analysis population is also not fully specified. The record says some participants had multiple anchors and that data were analyzed independently according to the specific device implanted. It does not report whether the primary endpoint analysis used all enrolled participants, only participants with available retrospective data, or another defined set. The statistical analysis plan, including any rules for analysis populations and outcome testing, is not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: recurrent rtc tear (2.6%), worsening left shoulder pain radiating down left arm, recurrent labral tear (2.4%), left rtc tear, rtc capsule sprain (2.4%), left shoulder pain with decreased rom, stiff and sore, adhesive capsulitis and rtc tendonitis (2.4%), right shoulder pain, ltd rom, rtc tear (2.4%).

Serious and other adverse-event counts are reported separately for seven device groups. Each group has a number of participants at risk and a number affected in each event category. For HEALICOIL™ PK Preloaded Suture Anchors, the serious adverse-event figures are 15 affected among 193 at risk; the other adverse-event figures are 40 among 193 at risk. For BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, the corresponding counts are 7 among 41 and 27 among 41. The other groups are reported in the same format.

These are descriptive registry counts, not randomized comparisons. The record states that the device groups are not like-for-like control arms and that participants could receive multiple anchors. The group counts therefore should not be added to obtain a unique-participant total or interpreted as directly comparable risks. The registry lists zero deaths in each device group.

The most frequently listed serious-event terms include RECURRENT RTC TEAR at 2.6%, and five other shoulder-related terms at 2.4% each. The record does not provide further details about how those term percentages were calculated. They are event-term summaries, not estimates of the primary clinical-success outcome. The methods for event collection, adjudication, and attribution are not reported in the registry record.

12. What the Result Does, and Does Not, Mean

The record establishes that a post-market follow-up study of PEEK suture anchors for shoulder indications was completed and that its primary outcome was defined as clinical success at six months. It also documents adverse-event counts across named device groups. These are useful descriptions of what the study intended to assess and what safety counts were posted.

The record does not report the primary outcome count, an effect estimate, or a statistical analysis. It therefore cannot show how often participants met the clinical-success definition or how precisely that frequency was estimated. The absence of a posted result is not evidence that the endpoint was met or not met. Likewise, the listed secondary outcomes do not establish their results, because those results are not reported in the registry record.

The adverse-event counts describe observed reporting categories but do not provide a controlled comparison. Allocation is not stated, and the record warns that the device groups are not like-for-like control groups. The counts cannot by themselves establish that one device group had a higher or lower underlying event risk. The note that some participants had multiple anchors also limits interpretation of the groups as distinct sets of people.

In general, a completed study record can be informative even when outcome analyses are unavailable: it identifies the question, the endpoint definition, the follow-up time, and the posted safety summaries. But a registry entry without endpoint results cannot answer the central effectiveness question, quantify statistical uncertainty, or support causal conclusions. No treatment recommendation follows from these registry entries.

13. Why This Trial Matters Statistically

This study illustrates why the difference between an endpoint definition and an endpoint result matters. The record gives a detailed six-month clinical-success definition, including device-related events, inflammatory or allergic response, and revision-related device deficiencies. Yet it does not report how many participants met that definition. Without the result and its denominator, readers cannot estimate the observed success frequency or its precision.

It also highlights the importance of identifying the unit of analysis. The record says some participants received multiple anchors and that device-specific data were analyzed independently. A participant-level outcome and device-level reporting can overlap. General statistical interpretation must account for that distinction rather than treating every device record as a separate, independent participant.

Finally, the safety data show why descriptive counts should not be mistaken for comparative evidence. The groups are not described as randomized or like-for-like controls, and allocation is not stated. Counts by device can support transparent reporting, but they do not alone isolate a device effect from differences in the people, procedures, or follow-up represented in each group.

These points are relevant in post-market studies, where real-world device reporting can contribute useful descriptive information while leaving important questions about design, analysis, and uncertainty unanswered. The registry record makes the outcome framework and safety categories visible, but its lack of posted endpoint analyses limits the conclusions that can be drawn.

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 principal limitation for interpreting this record is that the primary endpoint result is not reported in the registry record. No success count, denominator for the primary analysis, effect estimate, confidence interval, or test result is available. Although the study is marked completed, completion status does not resolve this reporting gap.

The design information is limited. Allocation is not stated, no randomized comparison is identified, and the device groups are explicitly not a like-for-like control comparison. The registry does not report eligibility criteria, participant characteristics, follow-up completeness, or the statistical analysis plan. It also does not describe the trial’s own sample-size justification or whether interim analyses were planned.

The endpoint combines several criteria and relies on surgeon assessment, but component-specific results and assessment procedures are not reported. The record does not describe missing-data handling, multiplicity procedures, or the defined analysis population. Those gaps prevent evaluation of potential bias and statistical uncertainty for the endpoint.

Safety reporting is organized by device group, while some participants had multiple anchors and device-specific data were analyzed independently. The record does not explain whether or how participant overlap was addressed in statistical analyses. Event-collection and adjudication methods are also not reported. These limitations are specific to interpreting the posted results and should not be filled by assumptions about the study protocol.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: PMCF Study on PEEK Suture Anchors for Shoulder Indications — NCT03826667.
• Registry record last updated 2022-04-12; status last verified 2022-02.
• Results first posted 2022-04-12.
• 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.

18. Record Summary

NCT03826667 is a completed post-market clinical follow-up study of PEEK suture anchors for shoulder indications, sponsored by Smith & Nephew, Inc. The registry lists enrollment of 464, a start date of 2019-02-14, and primary completion on 2019-08-28.

The primary outcome is the number of participants with clinical success at six months after intervention. Success was assessed by the surgeon using criteria covering inflammatory or allergic response, device-related adverse events, and device deficiencies leading to revision surgery. The registry also lists secondary outcomes for twelve-month success, pain, and range of motion.

Adverse-event counts are posted for seven device groups, with zero deaths listed for each. The record notes that some participants received multiple anchors and that device-specific data were analyzed independently. Allocation is not stated, and the groups are not a like-for-like control comparison. The primary endpoint result and statistical analyses are not reported in the registry record.