Arthropathy of Knee
Conditions
Keywords
Osteoarthritis, traumatic arthritis, avascular necrosis
Brief summary
The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.
Detailed description
The study design is a prospective, multi-center clinical trial. The Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercially available and is intended for cemented use. The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions. Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), 6 months (optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for 15 years post-implantation. The objectives of this study are to: 1. Evaluate the effect of system component design on functional performance. 2. Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative. 3. Evaluate complications and the rates in which they occur.
Interventions
DEVICEScorpio® CR Total Knee System
All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The subject is a male or non-pregnant female between the ages of 21-80. 2. The subject requires a primary cemented total knee replacement. 3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). 4. The subject has intact collateral ligaments. 5. The subject has signed the IRB approved, study specific Informed Patient Consent Form. 6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
1. Patient has inflammatory arthritis. 2. The subject is morbidly obese, \>60% over ideal body weight for frame and height. 3. The subject has a history of total or unicompartmental reconstruction of the affected joint. 4. Patient has had a high tibial osteotomy or femoral osteotomy. 5. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 6. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 7. The subject is immunologically suppressed, or receiving steroids in excess of normal physiological requirements. 8. The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 9. The subject has had a knee fusion to the affected joint. 10. The subject has an active or suspected latent infection in or about the knee joint. 11. The subject is a prisoner. 12. The subject is pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings. | 15 years | This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted. |
| Evaluate Complication Rate. | 15 years | This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted. |
Countries
United States
Participant flow
Pre-assignment details
215/229 subjects/cases enrolled and 5 subjects/cases censored=210/224 subjects/cases started
Participants by arm
| Arm | Count |
|---|---|
| Scorpio® CR Total Knee System Study Device All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device | 210 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Intercurrent illness | 1 |
| Overall Study | Lost to Follow-up | 22 |
| Overall Study | Overall Study Termination | 145 |
| Overall Study | Revision / Removal of Study Implant | 6 |
| Overall Study | Unable to return | 1 |
| Overall Study | Unwilling to return | 11 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Scorpio® CR Total Knee System Study Device |
|---|---|
| Age, Continuous | 64.46 years FULL_RANGE 8.98 |
| Region of Enrollment United States | 210 participants |
| Sex: Female, Male Female | 137 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 210 |
| serious Total, serious adverse events | 6 / 210 |
Outcome results
Primary
Evaluate Complication Rate.
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Time frame: 15 years
Primary
Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Time frame: 15 years