N/A
Completed N=84
Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT02520531 ↗
Enrolled (actual)
84
Serious AEs
27.4%
Results posted
Sep 2019
Primary outcomePrimary: Comparison of Maximum Passive and Active Flexion. — 124.58; 125.14; 126.64; 131.33 degree
Summary
Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Maximum Passive and Active Flexion. |
124.58; 125.14; 126.64; 131.33; 1.81; 2.72 | — |
| SECONDARY Knee Society Score (KSS) |
47.65; 49.85; 61.65; 69.63; 67.66; 75.38 | — |
| SECONDARY Chair Raise Test |
26; 30; 34; 37; 39; 39 | — |
| SECONDARY WOMAC Patient Questionnaire |
49.33; 47.63; 26.56; 18.69; 19.95; 20.21 | — |
| SECONDARY EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire |
0.60; 0.53; 0.76; 0.77; 0.76; 0.78 | — |
Eligibility Criteria
Inclusion Criteria
- Patients requiring a primary total knee arthroplasty (TKA)
- Male and nonpregnant female patients
- Between 18 and 80 years of age at time of surgery
- Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN), and not severe posttraumatic arthritis
- No previous osteosynthesis of the involved knee during the last 12 months
- Patients who understand the conditions of the study and are wiling to participate for the length of the described follow up
- Patients who are capable of, and have given, informed consent for participation in the study
Exclusion Criteria
- Patients requiring revision surgery of a previous implanted total knee system
- Patients with a diagnosis of severe posttraumatic arthritis (TA) and rheumatoid arthritis (RA)
- Patients with active infection
- Patients with malignancy
- Patients with an immobile hip or ankle arthrodesis
- Severe obese patients (BMI > 35)
- Patients with a neurological deficit
- Previous history of unicompartmental knee arthroplasty or patellar prosthesis
- Patients with concurrent illnesses which are likely to affect their outcome
Data sourced from ClinicalTrials.gov (NCT02520531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.