Arthroplasty, Replacement, Knee, Knee Arthroplasty, Total
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESCORPIO™
subjects randomized at surgery to receive 1 of the 2 specified implants
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled for primary TKA * non-inflammatory arthritis * intact Posterior Cruciate Ligament at the time of surgery
Exclusion criteria
* required bone grafting of either the femur or tibia * varus or valgus deformity of \> 15 degrees * previous high tibial osteotomy * unable to understand or comply with the study requirements * unable to provide signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain | 10 years postoperative | 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 |
| WOMAC Osteoarthritis Index Function | 10 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RAND -36 Health Survey | 10 years postoperative | 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. |
| Revision Rate | within 10 years of surgery | 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 |
| Number of Complications | within 10 years of surgery | — |
| Knee Range of Motion | knee ROM at 2 years postoperative | Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCS Group SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis
SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants | 49 |
| PCR Group SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis
SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants | 51 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 13 |
| Overall Study | Lost to Follow-up | 6 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | PCR Group | PCS Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 49 Participants | 100 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 69.2 years STANDARD_DEVIATION 9.1 | 70.2 years STANDARD_DEVIATION 8.4 | 69.7 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment Canada | 51 Participants | 49 Participants | 100 Participants |
| Sex: Female, Male Female | 27 Participants | 22 Participants | 49 Participants |
| Sex: Female, Male Male | 24 Participants | 27 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 5 / 49 | 2 / 51 |
Outcome results
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
Time frame: 10 years postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCS Group | Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain | 84.0 units on a scale | Standard Deviation 19.8 |
| PCR Group | Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain | 78.3 units on a scale | Standard Deviation 24.5 |
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
Time frame: 10 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCS Group | WOMAC Osteoarthritis Index Function | 67.9 units on a scale | Standard Deviation 25.6 |
| PCR Group | WOMAC Osteoarthritis Index Function | 72.7 units on a scale | Standard Deviation 23.3 |
Secondary
Knee Range of Motion
Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees
Time frame: knee ROM at 2 years postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCS Group | Knee Range of Motion | 105.8 degrees | Standard Deviation 13.5 |
| PCR Group | Knee Range of Motion | 105.9 degrees | Standard Deviation 13 |
Secondary
Number of Complications
Time frame: within 10 years of surgery
Population: These complications include the revisions already recorded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCS Group | Number of Complications | 6 Participants |
| PCR Group | Number of Complications | 2 Participants |
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.
Time frame: 10 years postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCS Group | RAND -36 Health Survey | 42.4 units on a scale | Standard Deviation 28.7 |
| PCR Group | RAND -36 Health Survey | 50.3 units on a scale | Standard Deviation 29.3 |
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
Time frame: within 10 years of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCS Group | Revision Rate | 5 Participants |
| PCR Group | Revision Rate | 2 Participants |