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This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.
RCT of 100 subjects undergoing primary TKA who were randomized to received either a SCORPIO™ PCS or PCR TKA.
Subjects were evaluated pre-operatively and at 2 and 10 years post-operatively using the Western Ontario (WOMAC) Osteoarthritis Index, the RAND-36 and knee range of motion (2 years only). Complication and revision rates were also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCS | Active Comparator | SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis |
|
| PCR | Active Comparator | SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCORPIO™ | Device | subjects randomized at surgery to receive 1 of the 2 specified implants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain | disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores | 10 years postoperative |
| WOMAC Osteoarthritis Index Function | disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| RAND -36 Health Survey | generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function. | 10 years postoperative |
| Revision Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Health Services - Edmonton zone | Edmonton | Alberta | TG6 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19047702 | Result | Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PCS Group | SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants |
| FG001 | PCR Group | SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCS Group | SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants |
| BG001 | PCR Group |
| 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 | Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain | disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores | Posted | Mean | Standard Deviation | units on a scale | 10 years postoperative |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCS Group | SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision of TKA | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of NACTRC | UAlberta | 780-407-8007 | ron.welch@ahs.ca |
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number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases |
| within 10 years of surgery |
| Number of Complications | within 10 years of surgery |
| Knee Range of Motion | Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees | knee ROM at 2 years postoperative |
| Withdrawal by Subject |
|
SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis
SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | WOMAC Osteoarthritis Index Function | disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores | Posted | Mean | Standard Deviation | units on a scale | 10 years |
|
|
|
| Secondary | RAND -36 Health Survey | generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function. | Posted | Mean | Standard Deviation | units on a scale | 10 years postoperative |
|
|
|
| Secondary | Revision Rate | number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases | Posted | Count of Participants | Participants | within 10 years of surgery |
|
|
|
| Secondary | Number of Complications | These complications include the revisions already recorded. | Posted | Count of Participants | Participants | within 10 years of surgery |
|
|
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| Secondary | Knee Range of Motion | Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees | Posted | Mean | Standard Deviation | degrees | knee ROM at 2 years postoperative |
|
|
|
| 5 |
| 49 |
| 0 |
| 49 |
| EG001 | PCR Group | SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants | 2 | 51 | 0 | 51 |
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