Trial · NCT01340144
Evaluation of Patellar Crepitus Following Total Knee Arthroplasty
NCT01340144, Completed, Colorado Joint Replacement; results first posted 2015-03-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Patellar Crepitus Following Total Knee Arthroplasty. Trials, record NCT01340144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01340144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Patellar Crepitus Following Total Knee Arthroplasty
- NCT number
- NCT01340144
- Status
- Completed
- Enrollment
- 1,250 participants, actual
- Lead sponsor
- Colorado Joint Replacement
- Conditions
- Total Knee Replacement
- First posted
- 2011-04-22
- Last updated
- 2015-03-25
- Results first posted
- 2015-03-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | Two years after TKA (Total Knee Arthroplasty) procedure | The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | Two years after TKA (Total Knee Arthroplasty) procedure | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | PFC Sigma PS TKA (Total Knee Arthroplasty) | Positive Crepitus | 78 | participants | |
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | Positive Crepitus | 82 | participants | |
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | PFC Sigma PS TKA (Total Knee Arthroplasty) | Symptomatic Crepitus | 31 | participants | |
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | Symptomatic Crepitus | 24 | participants | |
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | PFC Sigma PS TKA (Total Knee Arthroplasty) | Operative Crepitus | 18 | participants | |
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | Operative Crepitus | 7 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PFC Sigma PS TKA (Total Knee Arthroplasty) | 625 | |
| Overall Study | STARTED | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 625 | |
| Overall Study | COMPLETED | PFC Sigma PS TKA (Total Knee Arthroplasty) | 553 | |
| Overall Study | COMPLETED | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 567 | |
| Overall Study | NOT COMPLETED | PFC Sigma PS TKA (Total Knee Arthroplasty) | 72 | |
| Overall Study | NOT COMPLETED | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 58 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Failed total knee due to infection | Infections and infestations | PFC Sigma PS TKA (Total Knee Arthroplasty) | 4 | 625 | 4 |
| serious | Failed total knee due to infection | Infections and infestations | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 1 | 625 | 1 |
| serious | Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PFC Sigma PS TKA (Total Knee Arthroplasty) | 2 | 625 | 2 |
| serious | Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 0 | 625 | 0 |
| serious | Failed total knee due to arthrofibrosis | Musculoskeletal and connective tissue disorders | PFC Sigma PS TKA (Total Knee Arthroplasty) | 3 | 625 | 3 |
| serious | Failed total knee due to arthrofibrosis | Musculoskeletal and connective tissue disorders | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 0 | 625 | 0 |
| serious | Failed TKA due to chronic patellofemoral and mild tibiofemoral instability | Musculoskeletal and connective tissue disorders | PFC Sigma PS TKA (Total Knee Arthroplasty) | 1 | 625 | 1 |
| serious | Failed TKA due to chronic patellofemoral and mild tibiofemoral instability | Musculoskeletal and connective tissue disorders | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 0 | 625 | 0 |
| serious | Death | General disorders | PFC Sigma PS TKA (Total Knee Arthroplasty) | 6 | 625 | 6 |
| serious | Death | General disorders | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 3 | 625 | 3 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PFC Sigma PS TKA (Total Knee Arthroplasty) | ||
| Total, all-cause mortality | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | ||
| Total, other adverse events | PFC Sigma PS TKA (Total Knee Arthroplasty) | 0 | 625 |
| Total, other adverse events | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 0 | 625 |
| Total, serious adverse events | PFC Sigma PS TKA (Total Knee Arthroplasty) | 45 | 625 |
| Total, serious adverse events | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 29 | 625 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PFC Sigma PS TKA (Total Knee Arthroplasty) vs PFC Sigma HP PS TKA (Total Knee Arthroplasty): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01340144
GET https://conductscience.org/api/trials/v1/NCT01340144/events?page=2