High intra- and inter-observer reliability of planning implant size in MRI-based patient-specific instrumentation for total knee arthroplasty.

PURPOSE: Patient-specific instrumentation (PSI) in total knee arthroplasty (TKA) uses individually designed disposable guides to determine intraoperative bone cuts. The manufacturer provides the surgeon with proposed planning which can be modified and should be approved by the surgeon before the guides are produced. This study aims to assess the intra- and inter-observer reliability among preoperative planning by orthopaedic surgeons using PSI. The authors hypothesize a high intra- and inter-observer reliability in planning TKA using PSI. METHODS: Four orthopaedic surgeons modified and approved 40 preoperative MRI-based PSI plannings three times. The surgeons were blinded to their own and each other's results. Intra- and inter-observer reliability was obtained for planned implant size, resection, and position of the implant. RESULTS: Intra-observer reliability Intraclass Correlation Coefficients (ICC) were excellent for femoral and tibial implant size with a range of 0.948-0.995 and 0.919-0.988, respectively. Inter-observer reliability for femoral and tibial implant size showed an ICC range of 0.953-0.982 and 0.839-0.951, respectively. Next to implant size, intra- and inter-observer reliability demonstrated good to an excellent agreement (ICC > 0.75) for 7 out of 12 remaining parameters and 6 out of 12 remaining parameters, respectively. CONCLUSION: Preoperative planning of TKA implant size using MRI-based PSI showed excellent intra- and inter-observer reliability. Further research on the comparison of predicted implant size preoperatively to intraoperative results is needed.

Consistency in patient-reported outcome measures after total knee arthroplasty using patient-specific instrumentation: a 5-year follow-up of 200 consecutive cases.

PURPOSE: The purpose of this study was to evaluate the 5-year follow-up results of the first 200 total knee arthroplasties (TKA) performed by one high-volume surgeon, using patient-specific information (PSI). To date, there has been no other research into the mid-term follow-up of TKA performed using PSI. MATERIALS AND METHODS: A total of 184 consecutive patients (200 TKA) were evaluated. Outcome measures included implant survival rate, adverse events, and the following patient-reported outcome measures (PROMs); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS), Pain Visual Analogue Score (VAS) and EuroQol-5D Score (EQ-5D). RESULTS: Revision surgery was performed for late secondary prosthetic joint infection (n = 1, total revision), aseptic loosening (n = 1, tibial component revision), instability (n = 1, isolated polyethylene insert exchange), and polyethylene insert breakage (n = 1, isolated polyethylene insert exchange). Other adverse events were as follows: debridement, antibiotics and implant retention for early prosthetic joint infection (n = 1), surgical debridement for haemarthrosis (n = 1), superficial wound infection (n = 2), thromboembolic events (n = 2), compartment syndrome (n = 1), and nerve injury (n = 2). All median outcome scores for patient reported outcome measures at 5 years improved significantly compared with the preoperative values (p ≤ 0.05). Median outcome scores were not significantly different between 1- and 5-year moments of follow-up, except for a significant decrease of EQ-VAS (p ≤ 0.05) between these two follow-up moments. CONCLUSION: PROMs are consistent for 5-year follow-up of TKA using PSI. After 5 years of follow-up, revision surgery for any reason occurred in four patients (2%). LEVEL OF EVIDENCE: III.

Measurement of lower limb alignment: there are within-person differences between weight-bearing and non-weight-bearing measurement modalities.

PURPOSE: Previous studies have compared weight-bearing mechanical leg axis (MLA) measurements to non-weight-bearing measurement modalities. Most of these studies compared mean or median values and did not analyse within-person differences between measurements. This study evaluates the within-person agreement of MLA measurements between weight-bearing full-length radiographs (FLR) and non-weight-bearing measurement modalities (computer-assisted surgery (CAS) navigation or MRI). MATERIALS AND METHODS: Two independent observers measured the MLA on pre- and postoperative weight-bearing FLR in 168 patients. These measurements were compared to non-weight-bearing measurements obtained by CAS navigation or MRI. Absolute differences in individual subjects were calculated to determine the agreement between measurement modalities. Linear regression was used to evaluate the possibility that other independent variables impact the differences in measurements. RESULTS: A difference was found in preoperative measurements between FLR and CAS navigation (mean of 2.5° with limit of agreement (1.96 SD) of 6.4°), as well as between FLR and MRI measurements (mean of 2.4° with limit of agreement (1.96 SD) of 6.9°). Postoperatively, the mean difference between MLA measured on FLR compared to CAS navigation was 1.5° (limit of agreement (1.96 SD) of 4.6°). Linear regression analysis showed that weight-bearing MLA measurements vary significantly from non-weight-bearing MLA measurements. Differences were more severe in patients with mediolateral instability (p = 0.010), age (p = 0.049) and ≥3° varus or valgus alignment (p = 0.008). CONCLUSION: The clinical importance of this study lies in the finding that there are within-person differences between weight-bearing and non-weight-bearing measurement modalities. This has implications for preoperative planning, performing total knee arthroplasty (TKA), and clinical follow-up after TKA surgery using CAS navigation or patient-specific instrumentation. LEVEL OF EVIDENCE: III.

Patient-specific instruments for total knee arthroplasty can accurately predict the component size as used peroperative.

PURPOSE: Patients-specific instruments (PSI) for implantation of total knee arthroplasty (TKA) can be used to predict the implant size for both the femur and the tibia component. This study aims to determine the impact of approval of the PSI planning for TKA on the frequency of, and reason for intraoperative changes of implant sizes. METHODS: The clinical records of 293 patients operated with MRI- (90.4 %) and CT-based (9.6 %) PSI were reviewed for actual used implant size. Preoperative default planning from the technician and approved planning by the operating surgeon were compared with the intraoperative implanted component size for both the femur and tibia. Intraoperative reason for not following the default sizes was outdated. Furthermore, MRI- and CT-based PSI were compared for these outcomes. RESULTS: In 93.9 and 91.1 % for, respectively, the femur and tibia (n.s.), the surgeon planned size was implanted during surgery. The predicted size of the femur (p < 0.00) and the tibia (p < 0.00) component planned by a technician differed from the implanted component sizes in 62 (21.2 %) and 51 (17.4 %) patients, respectively. In 17 cases, the femoral component size was adapted intraoperative based on the expert opinion of the operating surgeon. In 26 cases, the tibia component was changed during the surgery because of a mediolateral overhang, sclerotic bone, medial or lateral release, limited extension and/or fixed varus deformity. The results between the MRI- and CT-based PSI did not differ (n.s.). CONCLUSIONS: PSI is a tool to help the surgeon to achieve the best possible results during TKA. The planning made by a technician should always be validated and approved by the operating surgeon who has the ultimate responsibility regarding the operation. With PSI, the operating surgeon is able to minimize intraoperative implant size errors in advance to improve operating room efficiency with possible lowering hospital costs per procedure. LEVELS OF EVIDENCE: III.