Total Knee ReplacementPhase 4PROFIXNCT01500252
Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty - A Randomized Clinical Trial
A Phase 4 study testing Patellar Replacement Prosthesis and Profix TKR with Patellar Retention in people with Total Knee Replacement, run by University of Alberta at 1 site in Canada.
Trial summary
Background: Despite the excellent results of total knee replacement, also known as total knee arthroplasty (TKA) there is persistent controversy over whether or not to replace the surface of the kneecap. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Patellar Replacement Prosthesis and Profix TKR with Patellar Retention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Sep 1996to Dec 2009
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for primary TKA to treat non-inflammatory arthritis
- age 40- 75 years of age
Who cannot join
- history of knee sepsis
- previous patellectomy
- previous high tibial osteotomy
- knee flexion contracture of >20 degrees
- varus or valgus deformity of > 20 degrees
- < 90 degrees of knee flexion
- tibial or femoral bone deficiency requiring augmentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty Using the PROFIX* Total Knee System
Background:
Despite the excellent results of total knee replacement, also known as total knee arthroplasty (TKA) there is persistent controversy over whether or not to replace the surface of the kneecap. Anterior knee pain, which occurs with variable and unpredictable frequency, continues to be a problem in a subset of TKA patients. Some clinicians replace the surface of all kneecaps during TKA to avoid repeat surgery, which occurs in approximately 10% of cases. However, others cite the complications attributed to replacing the surface of kneecap as reasons to avoid this procedure.
Read more
This study prospectively randomized patients receiving TKA into two groups, those receiving replacement of the kneecap surface and those left without replacement of the kneecap surface to determine clinical outcomes and revisions over the first 5-10 postoperative years.
Objectives:
The primary objective of this work was to compare pain, stiffness and function between groups at five years postoperatively. Secondarily, we compared pain, stiffness and function at one and 10 years postoperatively. Finally, we examined the number of reoperations following TKR over 10 years in the 2 groups of subjects. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.
Methods:
Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive a replacement of the kneecap surface or have no kneecap intervention. The Smith and Nephew Profix TKA system was implanted in all cases; the post-operative regimen was standardized. Subjects were assessed pre-operatively and at 1 and 5 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and MacMaster Osteoarthritis Index [WOMAC]) and generic health status (Short Form 36 [SF-36]) questionnaire. At the end of the five year follow-up, the study was extended to a 10-year followup and the same outcomes were assessed. The revision rate was also compared between the two groups at the end of the 10-year follow-up.
- Conditions
- Total Knee Replacement
- Being tested
- Patellar Replacement Prosthesis, Profix TKR with Patellar Retention
- Keywords
- Total Knee Replacement, Patellar Resurfacing, Health Related Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patellar Replacement ProsthesisDevice
The Profix™ Total Knee System, a posterior cruciate retaining prosthesis manufactured by Smith and Nephew, Inc. was utilized in all subjects. Subjects randomized to the Resurfaced group received an all polyethylene patellar implant
Profix TKR with Patellar RetentionDevice
All subjects received a Profix TKR. Subjects in the Patellar Retention group retained their native patellar surface.
| Study group | Role | What they receive |
|---|---|---|
| Patellar Resurfacing | Experimental | These subjects received a Profix TKR including an all polyethylene patellar implant. Receives: Device: Patellar Replacement Prosthesis |
| Patellar Retention | Active comparator | This group received a Profix TKR, but retained their native patella Receives: Device: Profix TKR with Patellar Retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative
This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).
The change score was calculated by subtracting the preoperative score from the five year score.
Measured: Preoperative to 5 years postoperative
Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 5 Years Postoperative
This measures the change in patients' reported function from preoperative to 5 years postoperative.
The WOMAC Function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).
The change score was calculated by subtracting the preoperative score from the five year score.
Measured: Preoperative to 5 years postoperative
Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 5 Years Postoperative
This is the change in the patients' perceived pain between preoperative and 5 years postoperative.
The WOMAC stiffness scale has a minimum value of 0 (maximal stiffness) to a maximum value of 100 (no stiffness).
The change score was calculated by subtracting the preoperative score from the five year score.
Measured: Preoperative to 5 years postoperative
Secondary outcomes (7)
Change in WOMAC Osteoarthritis Index Pain Score From Preoperative to 1 Year Postoperative
This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).
The change score was calculated by subtracting the preoperative score from the one year score.
Measured: Preoperative to 1 year postoperative
Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 1-year Postoperative
This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).
The change score was calculated by subtracting the preoperative score from the one year score.
Measured: Preoperative to 1 year postoperative
Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 1 Year Postoperative
This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).
The change score was calculated by subtracting the preoperative score from the one year score.
Measured: Preoperative to 1 year postoperative
Change in WOMAC Osteoarthritis Index Pain Score From 5 Years Postoperative to 10 Years Postoperative
This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).
The change score was calculated by subtracting the five year score from the 10 year score.
Measured: 5 years postoperative to 10 years postoperative
Change in WOMAC Osteoarthritis Index Function Score From 5 Years Postoperative to 10 Years Postoperative
This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).
The change score was calculated by subtracting the five year score from the 10 year score.
Measured: 5 years postoperative to 10 years postoperative
Change in WOMAC Osteoarthritis Index Stiffness Score From 5 Years Postoperative to 10 Years Postoperative
This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).
The change score was calculated by subtracting the five-year score from the 10 year score.
Measured: 5 years postoperative to 10 years postoperative
Number of Revision Surgeries
This measure examined the number of reoperation in the two groups of subjects
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startSep 1996
- Primary completionJun 2004
- Study completionDec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500252
- Sponsor's protocol ID
- Pro00002794
- Acronym
- PROFIX
- Status last verified
- Jul 2021
- First submitted
- 22 Dec 2011
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Beaupre L, Secretan C, Johnston DW, Lavoie G. A randomized controlled trial comparing patellar retention versus patellar resurfacing in primary total knee arthroplasty: 5-10 year follow-up. BMC Res Notes. 2012 Jun 7;5:273. doi: 10.1186/1756-0500-5-273.
PubMed 22676495
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty Using the PROFIX* Total Knee System
- ClinicalTrials.gov ID
- NCT01500252
- Acronym / sponsor ID
- PROFIX / Pro00002794
- Conditions
- Total Knee Replacement
- Keywords
- Total Knee Replacement, Patellar Resurfacing, Health Related Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Sep 1996
- Primary completion
- Jun 2004 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Posted 1 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Despite the excellent results of total knee replacement, also known as total knee arthroplasty (TKA) there is persistent controversy over whether or not to replace the surface of the kneecap. Anterior knee pain, which occurs with variable and unpredictable frequency, continues to be a problem in a subset of TKA patients. Some clinicians replace the surface of all kneecaps during TKA to avoid repeat surgery, which occurs in approximately 10% of cases. However, others cite the complications attributed to replacing the surface of kneecap as reasons to avoid this procedure.
This study prospectively randomized patients receiving TKA into two groups, those receiving replacement of the kneecap surface and those left without replacement of the kneecap surface to determine clinical outcomes and revisions over the first 5-10 postoperative years.
Objectives:
The primary objective of this work was to compare pain, stiffness and function between groups at five years postoperatively. Secondarily, we compared pain, stiffness and function at one and 10 years postoperatively. Finally, we examined the number of reoperations following TKR over 10 years in the 2 groups of subjects. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.
Methods:
Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive a replacement of the kneecap surface or have no kneecap intervention. The Smith and Nephew Profix TKA system was implanted in all cases; the post-operative regimen was standardized. Subjects were assessed pre-operatively and at 1 and 5 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and MacMaster Osteoarthritis Index [WOMAC]) and generic health status (Short Form 36 [SF-36]) questionnaire. At the end of the five year follow-up, the study was extended to a 10-year followup and the same outcomes were assessed. The revision rate was also compared between the two groups at the end of the 10-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patellar Resurfacing | Experimental | Device: Patellar Replacement ProsthesisThese subjects received a Profix TKR including an all polyethylene patellar implant. |
| Patellar Retention | Active comparator | Device: Profix TKR with Patellar RetentionThis group received a Profix TKR, but retained their native patella |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for primary TKA to treat non-inflammatory arthritis
- age 40- 75 years of age
Key exclusion criteria (7 listed)
- history of knee sepsis
- previous patellectomy
- previous high tibial osteotomy
- knee flexion contracture of >20 degrees
- varus or valgus deformity of > 20 degrees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patellar Replacement ProsthesisThe Profix™ Total Knee System, a posterior cruciate retaining prosthesis manufactured by Smith and Nephew, Inc. was utilized in all subjects. Subjects randomized to the Resurfaced group received an all polyethylene patellar implant | Device | Patellar Resurfacing |
| Profix TKR with Patellar RetentionAll subjects received a Profix TKR. Subjects in the Patellar Retention group retained their native patellar surface. | Device | Patellar Retention |
Primary outcome
Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative
Time frame: Preoperative to 5 years postoperative
This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain). The change score was calculated by subtracting the preoperative score from the five year score.
Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 5 Years Postoperative
Time frame: Preoperative to 5 years postoperative
This measures the change in patients' reported function from preoperative to 5 years postoperative. The WOMAC Function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations). The change score was calculated by subtracting the preoperative score from the five year score.
Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 5 Years Postoperative
Time frame: Preoperative to 5 years postoperative
This is the change in the patients' perceived pain between preoperative and 5 years postoperative. The WOMAC stiffness scale has a minimum value of 0 (maximal stiffness) to a maximum value of 100 (no stiffness). The change score was calculated by subtracting the preoperative score from the five year score.
7 secondary outcomes
Change in WOMAC Osteoarthritis Index Pain Score From Preoperative to 1 Year Postoperative
Time frame: Preoperative to 1 year postoperative
Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 1-year Postoperative
Time frame: Preoperative to 1 year postoperative
Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 1 Year Postoperative
Time frame: Preoperative to 1 year postoperative
Change in WOMAC Osteoarthritis Index Pain Score From 5 Years Postoperative to 10 Years Postoperative
Time frame: 5 years postoperative to 10 years postoperative
Change in WOMAC Osteoarthritis Index Function Score From 5 Years Postoperative to 10 Years Postoperative
Time frame: 5 years postoperative to 10 years postoperative
Change in WOMAC Osteoarthritis Index Stiffness Score From 5 Years Postoperative to 10 Years Postoperative
Time frame: 5 years postoperative to 10 years postoperative
Number of Revision Surgeries
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22676495Beaupre L, Secretan C, Johnston DW, Lavoie G. A randomized controlled trial comparing patellar retention versus patellar resurfacing in primary total knee arthroplasty: 5-10 year follow-up. BMC Res Notes. 2012 Jun 7;5:273. doi: 10.1186/1756-0500-5-273.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patellar Replacement Prosthesis and Profix TKR with Patellar Retention in people with Total Knee Replacement, run by University of Alberta at 1 site in Canada.
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 2 inclusion and 7 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 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2012). 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?
Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative (time frame: Preoperative to 5 years postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01500252, which also lists 1 linked publication.
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 27 Jul 2021.