Prospective, Randomized, Single-blind, Multinational, Long-term Study for the Evaluation of the Clinical Outcome, Oxidation Profile and Wear Analysis of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Aesculap AG
- Enrollment
- 605
- Locations
- 8
- Primary Endpoint
- Clinical Outcome measured with the KSS [performance]
Study Overview
Brief Summary
Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Indication for a total knee replacement with a mobile-bearing UC or PS inlay
- •Written informed consent for participating at the clinical study
- •Willingness and mental ability to participate at the long-term follow-up examinations
Exclusion Criteria
- •Patient age < 18 and > 80 years
- •Pregnancy
- •High risk patients (ASA class >3)
Outcomes
Primary Outcomes
Clinical Outcome measured with the KSS [performance]
Time Frame: 10 years postoperatively
The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
Secondary Outcomes
- Progress of Clinical Outcome [Oxford Score] compared to baseline(Preoperatively, 3 months, 12 months, 3 years, 5 years, 7 years, 10 years)
- Survival rate(until the last follow-up at 10 years postoperatively)
- Quality of Life [EQ-5D-5L](Preoperatively, 3 months, 12 months, 5 years, 10 years)
- Comparison of Radiographic evaluation over time(baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years)
- Comparison of Radiographic alignment over time(baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years)
- Oxidation profile and wear analysis of available retrievals(During the course of the study up to 10 years postoperatively)
- Further analysis of patients having a revision of the primary implant(During the course of the study up to 10 years postoperatively)
- (Serious) Adverse Events(During the course of the study up to 10 years postoperatively)