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Do Customized Implants Yield Superior Clinical and Functional Outcomes Compared to Off-the-Shelf Implants in Primary
Muhammad Hamza Ilyas1, Isaiah Freeman1, William T Sampson1
1Department of Orthopaedic Surgery, Bioengineering Laboratory, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Background:
Customized individually made (CIM) total knee arthroplasty (TKA) implants are designed using preoperative computed tomography to optimize component fit, mechanical alignment, and joint line restoration. Despite their theoretical advantages, clinical adoption and evidence demonstrating meaningful functional benefits over off-the-shelf (OTS) implants are limited. This study aimed to compare clinical outcomes and rates of achieving the minimal clinically important difference (MCID) in patient-reported outcome measures (PROMs) between CIM and OTS implants using a propensity-matched analysis.
Methods:
A retrospective cohort study was conducted at a single institution following Institutional Review Board approval. Among 2,474 consecutive primary TKAs, 258 CIM and 774 OTS patients were identified using 1:3 nearest-neighbor propensity score matching based on demographic and comorbidity variables. The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10-a (SF-10a), PROMIS Global-Physical, PROMIS Global-Mental, and Knee Injury and Osteoarthritis Outcome Score-Physical Function Shortform was collected for analysis. The proportions of clinically meaningful change were calculated with MCID using the distribution-based method. The 90-day, and 1- and 2-year complication rates were recorded. After matching, there were no differences in baseline demographics between groups (P > 0.05).
Results:
Customized TKA patients had higher preoperative and postoperative SF-10a, PROMIS Global Mental, and PROMIS Global Physical scores (P < 0.05) and higher preoperative Knee Injury and Osteoarthritis Outcome Score-Physical Function Shortform scores (P < 0.05) when compared to OTS patients. Similar changes in scores and proportions of clinically meaningful improvement and worsening were seen between groups in all PROMs (P > 0.05). Similar 90-day, 1-year, and 2-year complication rates were present in both groups (P > 0.05).
Conclusions:
This study demonstrated that CIM implants were associated with similar clinical and patient-perceived outcomes compared to OTS implants when evaluated using MCID-based thresholds. These findings may inform preoperative patient counseling for individuals considering TKA.
