Total Knee ReplacementNCT01340144
Evaluation of Patellar Crepitus Following Total Knee Arthroplasty
An observational study of Total Knee Replacement, run by Colorado Joint Replacement.
Trial summary
Analyze clinical data for a group of subjects implanted with a new surgical device designed to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that to a control group of subjects implanted with a TKA design known to have an incidence of patellar crepitus of approximately 5%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Replacement
- How many people
- 1,250 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Sep 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Colorado Joint replacement clinic
Who may be able to join
- subjects that received primary total knee replacement
Who cannot join
- Did not return for follow - up appointments Required any post operative manipulation
About this study
Official title: Evaluation of Patellar Crepitus Following PFC Sigma vs. PFC Sigma HP Total Knee Arthroplasty: Does Femoral Component Design Make a Difference?
Analyze clinical data for a group of subjects implanted with a new surgical device designed to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that to a control group of subjects implanted with a TKA design known to have an incidence of patellar crepitus of approximately 5%.
Read the detailed description
Patellar crepitus and clunk following posterior cruciate substituting total knee arthroplasty is a persistent problem with a reported incidence as high as 14%. The development of this complication necessitates additional surgery in some patients. Numerous etiologies have been reported including design of the femoral component. Due to a higher than desired incidence of patellar crepitus with the PFC Sigma PS TKA, design modifications of the trochlear groove of the femoral component were introduced with the release of the PFC Sigma HP PS femoral component. The purpose of the proposed study is to evaluate the incidence of patellar crepitus after posterior cruciate substituting TKA utilizing the PFC Sigma vs. the PFC Sigma HP PS femoral components.
- Conditions
- Total Knee Replacement
- Keywords
- total knee replacement, patellar crepitus, Replacement of knee joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PFC Sigma PS TKA | one group received primary TKA using the PFC Sigma PS TKA | |
| PFC Sigma HP PS TKA | One group received primary TKA using the PFC Sigma HP PS TKA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Two years after TKA (Total Knee Arthroplasty) procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Joint Replacement
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Raymond Kim, MD, Principal investigator, Porter Adventist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340144
- Sponsor's protocol ID
- IIS-000112
- Status last verified
- Mar 2015
- First submitted
- 20 Apr 2011
- Last updated
- 25 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patellar Crepitus Following PFC Sigma vs. PFC Sigma HP Total Knee Arthroplasty: Does Femoral Component Design Make a Difference?
- ClinicalTrials.gov ID
- NCT01340144
- Acronym / sponsor ID
- IIS-000112
- Conditions
- Total Knee Replacement
- Keywords
- total knee replacement, patellar crepitus, Replacement of knee joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Colorado Joint ReplacementUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Apr 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Posted 5 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analyze clinical data for a group of subjects implanted with a new surgical device designed to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that to a control group of subjects implanted with a TKA design known to have an incidence of patellar crepitus of approximately 5%.
Detailed description
Patellar crepitus and clunk following posterior cruciate substituting total knee arthroplasty is a persistent problem with a reported incidence as high as 14%. The development of this complication necessitates additional surgery in some patients. Numerous etiologies have been reported including design of the femoral component. Due to a higher than desired incidence of patellar crepitus with the PFC Sigma PS TKA, design modifications of the trochlear groove of the femoral component were introduced with the release of the PFC Sigma HP PS femoral component. The purpose of the proposed study is to evaluate the incidence of patellar crepitus after posterior cruciate substituting TKA utilizing the PFC Sigma vs. the PFC Sigma HP PS femoral components.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFC Sigma PS TKA | – | –one group received primary TKA using the PFC Sigma PS TKA |
| PFC Sigma HP PS TKA | – | –One group received primary TKA using the PFC Sigma HP PS TKA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Colorado Joint replacement clinic
Key inclusion criteria (1 listed)
- subjects that received primary total knee replacement
Key exclusion criteria (1 listed)
- Did not return for follow - up appointments Required any post operative manipulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Kim, MD principal investigator
Porter Adventist Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement, run by Colorado Joint Replacement.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Two years after TKA (Total Knee Arthroplasty) procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.