Clinical trial NCT00894361: Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
Official title: A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: knee arthritis
total knee arthroplasty
total knee replacement
mobile bearing design
all-polyethylene tibia
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Depuy, Inc.
First posted: 2009-05-07
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* generally accepted clinical and radiographic criteria for primary total knee arthroplasty

Exclusion Criteria:

* substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
* patients whose mental function precluded them from responding to our standard questionnaires

Primary outcomes:
measure: Knee Postoperative Range of Motion (ROM) at 2 Years
timeFrame: 2 years
Secondary outcomes:
measure: Survival of the Implants to Subject Death or Implant Removal
timeFrame: 10 or more years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
Study officials:
affiliation: Minneapolis VAMC, Dept. of Orthopaedic Surgery
name: Terence J Gioe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01442.