Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
Public ClinicalTrials.gov record NCT00894361. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas: 1. Does a RP design offer improvement in range of motion over a AP design? 2. Does a RP design have improved wear characteristics over a nonmodular AP design? 3. Is there a clear clinical advantage to the RP design that justifies its increased cost? Answering these questions will allow surgeons to use RP designs appropriately in different demand populations. This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.
Study identification
- NCT ID
- NCT00894361
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
- TKA surgery with the rotating platform mobile-bearing knee design Procedure
- TKA surgery with the all-polyethylene tibia knee design Procedure
Procedure
Eligibility (public fields only)
- Age range
- 60 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2001
- Primary completion
- Dec 31, 2006
- Completion
- Dec 31, 2006
- Last update posted
- Sep 6, 2020
2001 – 2007
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Minneapolis VAMC | Minneapolis | Minnesota | 55417 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00894361, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 6, 2020 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00894361 live on ClinicalTrials.gov.