N/A
Completed N=96
Polyethylene Wear Study on the Triathlon Total Knee Prosthesis
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT02525588 ↗
Enrolled (actual)
96
Serious AEs
47.9%
Results posted
Apr 2020
Primary outcomePrimary: Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). — -0.08; -0.03; 0.22; 0.22 mm
Summary
Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with highly cross-linked polyethylene (X3) in a condylar stabilizing (CS) fixed bearing total knee prosthesis by means of RSA and clinical evaluation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). |
-0.08; -0.03; 0.22; 0.22; -0.03; -0.00 | — |
| SECONDARY Assessment of Prosthetic Migration Results After Two Years by RSA. |
0.723; 0.925; 0.894; 0.962; 0.912; 1.023 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) |
49.09; 50.05; 68.67; 66.06; 77.45; 78.99 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) |
47.40; 44.81; 30.45; 26.99; 48.91; 47.14 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire |
0.52; 0.55; 0.65; 0.65; 0.75; 0.72 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire |
9.29; 8.98; 7.13; 7.06; 9.17; 8.73 | — |
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.
- Patients with a pre-operative knee score of 40.
- Skeletal immaturity of the patient, patients who are less than 18 years of age.
- Patient has a flexion contracture of 15° and more.
- Patient has a varus/valgus contracture of 15° and more.
- Patients with a pre-operative knee score of >70.
- 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).
- The subject has an active or suspected latent infection in or about the knee joint.
- Osteomyelitis.
- Sepsis.
- Patients who will need lower limb joint replacement for another joint within one year.
- 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.
- Female patients planning a pregnancy during the course of the study.
- The patient is unable or unwilling to sign the Informed Consent specific to this study.
Data sourced from ClinicalTrials.gov (NCT02525588). 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.