Outcome Study of Highly-cross Linked Polyethylene vs. Standard Polyethylene for Primary Posterior Stabilized (PS) Total Knee
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/2/2017 |
| Start Date: | July 2009 |
| End Date: | July 2019 |
Prospective, Randomized Study of Highly-cross Linked Polyethylene vs. Compression Molded Polyethylene for Primary Posterior-stabilized Total Knee Arthroplasty
Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing
total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced
to decrease this problem, but there is little data on the results and complications of this
polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following
questions: (1) Are there any differences in the clinical and radiographic results when a
highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency
of reoperation in these two groups and are there any specific complications related to
highly cross-linked polyethylene liners.
total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced
to decrease this problem, but there is little data on the results and complications of this
polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following
questions: (1) Are there any differences in the clinical and radiographic results when a
highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency
of reoperation in these two groups and are there any specific complications related to
highly cross-linked polyethylene liners.
This prospective, randomized study will seek to enroll patients undergoing primary total
knee arthroplasty. Preoperative evaluation will include a detailed history and physical exam
with clinical data collection (SF-36, WOMAC, and Knee Society Scores), a complete
description of the procedure, a demonstration of the actual types of implants and tibial
inserts, and an outline of the study protocol and informed consent. Intraoperatively, the
patient will undergo a total knee arthroplasty utilizing standard operative procedures. Each
patient will receive a Zimmer NexGen posterior-stabilized total knee arthroplasty. During
the procedure or preoperative visit, the patient will be randomized by sealed envelope to
receive either a standard Zimmer UHMWPE tibial insert or a Zimmer highly cross-linked UHMWPE
tibial insert. Both surgeon and patient will be blinded to the type of implant used. there
will be no variations in surgical technique and hospital management of the patients
throughout the course of the study. Postoperatively, the patient will be seen for routine
follow-up at six weeks, 6 months, 1 year and yearly thereafter. Radiographs will be obtained
at each visit. Clinical data forms will be completed at each visit. At the conclusion of the
study radiographs will be assessed for signs of polyethylene wear, osteolysis and component
loosening. the preoperative and postoperative knee scores will be calculated for each
patient and compared between the patient groups with standard statistical analysis.
knee arthroplasty. Preoperative evaluation will include a detailed history and physical exam
with clinical data collection (SF-36, WOMAC, and Knee Society Scores), a complete
description of the procedure, a demonstration of the actual types of implants and tibial
inserts, and an outline of the study protocol and informed consent. Intraoperatively, the
patient will undergo a total knee arthroplasty utilizing standard operative procedures. Each
patient will receive a Zimmer NexGen posterior-stabilized total knee arthroplasty. During
the procedure or preoperative visit, the patient will be randomized by sealed envelope to
receive either a standard Zimmer UHMWPE tibial insert or a Zimmer highly cross-linked UHMWPE
tibial insert. Both surgeon and patient will be blinded to the type of implant used. there
will be no variations in surgical technique and hospital management of the patients
throughout the course of the study. Postoperatively, the patient will be seen for routine
follow-up at six weeks, 6 months, 1 year and yearly thereafter. Radiographs will be obtained
at each visit. Clinical data forms will be completed at each visit. At the conclusion of the
study radiographs will be assessed for signs of polyethylene wear, osteolysis and component
loosening. the preoperative and postoperative knee scores will be calculated for each
patient and compared between the patient groups with standard statistical analysis.
Inclusion Criteria:
- all patients indicated for primary total posterior stabilized knee arthroplasty
Exclusion Criteria:
- patients who refused participation
- patients who did not comprehend the English language to give informed consent
- patients with severe knee deformity thought to require a primary constrained condylar
prosthesis
We found this trial at
1
site
Click here to add this to my saved trials
