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Comparison · NCT01340144-sae

PFC Sigma PS TKA (Total Knee Arthroplasty) vs PFC Sigma HP PS TKA (Total Knee Arthroplasty): serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. PFC Sigma PS TKA (Total Knee Arthroplasty) vs PFC Sigma HP PS TKA (Total Knee Arthroplasty): serious adverse events. Trial comparisons, record NCT01340144-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01340144-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.0720.05420.095wilson
Risk in group 20.04640.03250.0658wilson
Risk difference, group 1 minus group 20.0256-0.0007320.0525newcombe hybrid score
Risk ratio, group 1 over group 21.550.9862.44log
Odds ratio, group 1 over group 21.590.9862.58log
Number needed to harm, for one more participant with a serious adverse event on PFC Sigma PS TKA (Total Knee Arthroplasty) than on PFC Sigma HP PS TKA (Total Knee Arthroplasty)39.1from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1PFC Sigma PS TKA (Total Knee Arthroplasty)One group received primary TKA using the PFC Sigma PS TKA45625EG000
Group 2PFC Sigma HP PS TKA (Total Knee Arthroplasty)One group received primary TKA using the PFC Sigma HP PS TKA.29625EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Evaluation of Patellar Crepitus Following Total Knee Arthroplasty
NCT number
NCT01340144
Phases
Conditions
Total Knee Replacement
Interventions
Lead sponsor
Colorado Joint Replacement
Results first posted
2015-03-05

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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