Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patellar Resurfacing | Experimental | These subjects received a Profix TKR including an all polyethylene patellar implant. |
|
| Patellar Retention | Active Comparator | This group received a Profix TKR, but retained their native patella |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patellar Replacement Prosthesis | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Preoperative to 5 years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperative to 1 year postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22676495 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patellar Resurfacing | Subjects received patellar resurfacing. |
| FG001 | Patellar Retention | Subjects retained their native patella. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patellar Resurfacing | Subjects received patellar resurfacing. |
| BG001 | Patellar Retention | Subjects retained their native patella. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Preoperative to 5 years postoperative |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patellar Resurfacing | Subjects received patellar resurfacing. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Beaupre | UAlberta | 780-407-3945 | lauren.beaupre@albertahealthservices.ca |
Not provided
Not provided
Not provided
Not provided
Not provided
| Profix TKR with Patellar Retention | Device | All subjects received a Profix TKR. Subjects in the Patellar Retention group retained their native patellar surface. |
|
| 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. | 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. | 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. | 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. | 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. | 5 years postoperative to 10 years postoperative |
| Number of Revision Surgeries | This measure examined the number of reoperation in the two groups of subjects | 10 years |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects retained their native patella. |
|
|
|
| Secondary | 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. | Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Preoperative to 1 year postoperative |
|
|
|
|
| Secondary | 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. | Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Preoperative to 1 year postoperative |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Preoperative to 1 year postoperative |
|
|
|
|
| Primary | 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. | One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Preoperative to 5 years postoperative |
|
|
|
|
| Primary | 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. | One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Preoperative to 5 years postoperative |
|
|
|
|
| Secondary | 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. | Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 5 years postoperative to 10 years postoperative |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 5 years postoperative to 10 years postoperative |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 5 years postoperative to 10 years postoperative |
|
|
|
|
| Secondary | Number of Revision Surgeries | This measure examined the number of reoperation in the two groups of subjects | All participants were analyzed. | Posted | Number | participants | 10 years |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Patellar Retention | Subjects retained their native patella. | 0 | 17 | 0 | 17 |
Not provided
Not provided