N/A
N=61
Stability of the Medial Pivot Total Knee Prosthesis
Osteoarthritis of Knee
Bottom Line
View on ClinicalTrials.gov: NCT02577978 ↗Enrolled (actual)
61
Serious AEs
—
Results posted
May 2019
Primary outcome: Primary: Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative — 16.31; 19.88; 29.96; 28.52 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medacta GMK posterior stabilized prosthesis (Device); Medacta GMK Sphere prosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative |
16.31; 19.88; 29.96; 28.52; 32.0; 32.7 | — |
| PRIMARY Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative |
44.97; 54.33; 49.25; 59; 51.11; 53.71 | — |
| PRIMARY Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative |
26.74; 23.92; 34.5; 34.02; 38.27; 35.9 | — |
| PRIMARY PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative |
32.92; 31.24; 38.38; 39.96; 42.12; 41.32 | — |
| PRIMARY PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative |
66.03; 65.88; 58.23; 58.2; 55.9; 55.53 | — |
| PRIMARY PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative |
60.98; 60.92; 56.79; 58.49; 54.14; 53.6 | — |
| PRIMARY Total Score Calculated Using the Forgotten Joint Score in Order to Assess the Subject's Ability to Forget the Artificial Joint in Everyday Life |
57.1; 54.6 | — |
| PRIMARY International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op |
35.82; 35.97; 42.38; 43.91; 50.41; 44.5 | — |
| PRIMARY Score for the Knee Society Score (KSS) Knee Component at 1 Year Post-operatively |
88.1; 86.0 | — |
| PRIMARY Score for the Knee Society Score (KSS) Function Component at 1 Year Post-operatively |
81.4; 77.4 | — |
| SECONDARY Assessing Knee Stability Using the KT-1000 Arthrometer (at 30 Degrees) |
5.6; 10.2 | — |
| SECONDARY Assessing Knee Stability Using the KT-1000 Arthrometer (at 90 Degrees) |
4.1; 5.6 | — |
| SECONDARY Get-up-and-Go Test |
10.2; 10.5 | — |
Summary
The purpose of this study is to compare objective and subjective measures of knee stability following total knee arthroplasty with a medial pivot design vs. a posterior stabilized design.
Eligibility Criteria
Inclusion Criteria
- Age 18-85, regardless of gender, ethnicity, or pathology
- Must require a total knee arthroplasty
- All subjects must have given signed, informed consent prior to registration in study.
Exclusion Criteria
- Minors
- Any patients that are unable to consent
- Patients with active infection or osseous tumor of the operative extremity
- Patients undergoing revision surgery
Data sourced from ClinicalTrials.gov (NCT02577978). 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.