N/A
Completed N=205
Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT02524730 ↗
Enrolled (actual)
205
Serious AEs
42.9%
Results posted
Jun 2021
Primary outcomePrimary: Survival Rate — 2; 1; 1; 4 Participants
Summary
The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Rate |
2; 1; 1; 4; 189 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) |
57.84; 78.71; 83.27; 83.85; 84.73; 84.20 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire |
8.61; 9.43; 11.11; 10.68; 10.38; 10.75 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) |
30.62; 40.2; 44.67; 43.97; 42.41; 43.07 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. |
49.91; 79.58; 83.38; 85.83; 41.28; 82.9 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). |
70.97; 76.96; 77.41; 75.09; 76.84; 77.03 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
- The subject is a male or non-pregnant female between 40 and 75 years of age.
- The subject requires a primary total knee replacement.
- Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis)
- The subject has intact collateral ligaments.
- The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- The subject is capable of understanding the patient scores in the national language.
Exclusion Criteria
- The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- The subject will be operated bilaterally.
- Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study).
- Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study).
- Patients who will need lower limb joint replacement for another joint within one year.
- The subject has had a high tibial osteotomy or femoral osteotomy.
- The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
- The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- The subject has had a knee fusion to the affected joint.
- The subject has an active or suspected latent infection in or about the knee joint.
- Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition).
- Female patients planning a pregnancy during the course of the study.
- The subject is a prisoner.
- severe deformities: varus/valgus deformity >10° (mech. axis), bowed femur > 20 degree, flexion contracture >10°
Data sourced from ClinicalTrials.gov (NCT02524730). 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.