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Abnormal rate of intraoperative and postoperative implant positioning outliers using "MRI-based patient-specific" compared to "computer assisted" instrumentation in total knee replacement.
PURPOSE: The aim of this study was to analyze first intraoperative alignment and reason to abandon the use of patient-specific instrumentation using intraoperative CAS measurement, secondly assess by postoperative CT analysis if CI, based on preoperative 3D-MRI data, improved postoperative component positioning (including femoral rotation) and lower limb alignment as compared with results obtained with CAS.
METHODS: In this randomized controlled trial, 80 consecutive patients scheduled to undergo TKA were enrolled. Eligible knees were randomized to the group of PSI-TKAs (n = 40) or to the group of CAS-TKAs (n = 40). In the CAS group, CAS determined and controlled cutting block positioning in each plane. In the PSI group, CAS allowed to measure adequacy of intraoperative alignment including femoral component rotation. At 3 months after surgery, implants position were measured and analyzed with full-weight bearing plain radiographs and CT scan.
RESULTS: Intraoperatively, there was a significant difference concerning Sagittal Femoral mechanical, Frontal tibial mechanical angle and tibial slope between the two groups (respectively p = 0.01, p = 0.02, p = 0.046). Custom instrumentation was abandoned intraoperatively in seven knees (17.5 %). Abnormal tibial cuts were responsible of the abandon in three out of seven cases, femoral cut in 1/7 and dual abnormalities in 3/7. Postoperatively, tibial slope outliers percentage was higher in the patient specific instrumentation group with six patients (18.18 %) versus one patient (2.5 %) in the CAS group (p = 0.041).
CONCLUSION: Patient specific instrumentation was associated with an important number of hazardous cut and a higher rate of outliers in our series and thus should be used with caution as related to. This study is the first to our acknowledgement to compare intra-operative ancillary and implant positioning of PSI-TKA and CAS-TKA. High rate of malposition are sustained by our findings, as such PSI-TKA should be used with caution, by surgeons capable to switch to conventional instrumentation intra-operatively.
LEVEL OF EVIDENCE: Randomized control trial, Level I.
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