N/A
N=518
X-3 Polyethylene Survival Outcomes Study
Arthroplasty, Replacement, Knee · Total Knee Replacement
Bottom Line
View on ClinicalTrials.gov: NCT00493792 ↗Enrolled (actual)
518
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Prosthesis Survivorship Free of Revision — 96; 97 percentage of prosthesis survivorship — p=0.47
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- X3 Polyethylene (Device); N2Vac Polyethylene (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prosthesis Survivorship Free of Revision |
96; 97 | 0.47 |
| SECONDARY Prosthesis Survivorship Free of Reoperation |
92; 96 | 0.06 |
| SECONDARY Prosthesis Survivorship Free of Complications |
84.9; 88.8 | 0.193 |
| SECONDARY Knee Society Score (KSS) |
39.9; 39.0; 77.6; 76.5 | — |
| SECONDARY Knee Society Score (KSS): Function |
58.3; 59.1; 70.2; 70.3 | — |
| SECONDARY 12-Item Short Form Health Survey (SF-12): Mental Health Score |
56; 56.2; 56.8; 56.3 | — |
| SECONDARY 12-Item Short Form Health Survey (SF-12): Physical Health Score |
32.5; 33.2; 41.9; 44.4 | — |
| SECONDARY Comparison of Radiographic Success/Failure Between Groups |
0; 0; 7; 2; 3; 0 | — |
Summary
The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected.
It is hypothesized that X3 would perform equally well to N2Vac at 10 years.
Eligibility Criteria
INCLUSION CRITERIA
- Subjects willing to sign the informed consent.
- Subjects able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.
- Male and non-pregnant female subjects ages 21-85 years of age at the time of surgery.
- Subjects requiring a primary total knee replacement.
- Subjects with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- Subjects with intact collateral ligaments as determined by the surgeon investigator.
EXCLUSION CRITERIA
- Subjects with inflammatory arthritis.
- Subjects with a history of total or unicompartmental reconstruction of the affected joint.
- Subjects that have had a high tibial osteotomy or femoral osteotomy.
- Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Subjects with a systemic or metabolic disorder leading to progressive bone deterioration.
- Subjects that are immunologically compromised, or receiving chronic steroids (>30 days).
- Subjects bone stock is compromised by disease or infection that cannot provide adequate support and/or fixation to the prosthesis.
- Subjects with knee fusion to the affected joint.
- Subjects with an active or suspected latent infection in or about the knee joint.
- Subjects that are prisoners.
Data sourced from ClinicalTrials.gov (NCT00493792). 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.