Abstract
Purpose
The foam metal backed Advance BioFoam Knee Arthroplasty components utilize a porous titanium coating on the underside of the tibial baseplate, intended to promote bone in-growth and provide a more robust bone-implant interface without cement. There is also a version of the Biofoam Advance that incorporates screwed fixation that allows for augmented fixation with up to four titanium screws; however, it is not clear that this augmentation is necessary. The purpose of this study was to employ radiostereometric analysis (RSA) to compare implant migration in a randomized controlled trial of this implant design with or without screw fixation.
Method
Fifty-one patients were randomized to receive a BioFoam total knee replacement (Wright Medical Technologies) with or without screw fixaiton. During surgery, eight tantalum markers, one millimetre in diameter, were inserted into the proximal tibia. Using a calibration box, stereo RSA radiographs were taken post-operatively and then again at six weeks and three, six and 12 months following surgery. Model Based RSA was used with 3D models of the tibial component to measure migration. Health status and functional outcome measures were recorded to quantify functional status of subjects before surgery and at each follow-up interval.
Results
The migration results at one year, calculated as maximum total point motion (MTPM) were 1.751.93 mm for with screw fixation and 1.431.41 mm without screw fixation (p value =0.575). The clinical precision of the MTPM metric is 0.33 mm, calculated as the standard deviation of measurements made from double exams of all patients. There were no significant differences between groups for all other outcomes.
Conclusion
The migration results at one year indicate that the addition of screws does not impact implant fixation in the short term. Longer term monitoring of the migration of these two implant groups will continue. Although higher than the migration seen with cemented tibial components, the amount of migration is comparable to other uncemented designs.
