Orthopedics

Feature Article 

Patient-Specific Instrumentation Does Not Improve Accuracy in Total Knee Arthroplasty

Chong Shen, MD; Zhi-Hong Tang, MD; Jun-Zu Hu, MD; Guo-Yao Zou, MD; Rong-Chi Xiao, MD; Dong-Xue Yan, MD

Abstract

Patient-specific instrumentation (PSI) has been introduced as a tool to increase the accuracy of total knee arthroplasty (TKA) compared with conventional instrumentation (CLI). However, previous studies have shown inconsistent results. The authors conducted a meta-analysis to compare the performance of PSI to CLI in TKA. PubMed, EMBASE, and Cochrane Central Register of Controlled Trials electronic databases were systematically searched to identify eligible trials published between 2000 and March 2014. Two reviewers independently assessed methodological quality according to the Cochrane Handbook. Subgroup analyses were performed based on the different study designs (randomized, controlled trial [RCT] vs non-randomized, controlled trial [non-RCT]), preoperative magnetic resonance imaging vs computed tomography, and systems of PSI to explore the source of heterogeneity. Fourteen studies (7 RCTs and 7 non-RCTs) involving 1906 patients were included. There were no statistical differences with respect to the outliers of mechanical axis, coronal femoral component, sagittal femoral component, femoral component rotation, operative time, blood loss, and length of hospital stay between PSI and CLI groups. The number of outliers in coronal tibial components (odds ratio, 2.29; 95% confidence interval, 1.20 to 4.35; P=.01) and sagittal tibial components (odds ratio, 1.67; 95% confidence interval, 1.16 to 2.42; P<.01) was significantly lower in the CLI group than in the PSI group. Based on the numbers available, the use of PSI compared with CLI was not likely to improve the accuracy of component alignment and treatment effects of TKA. Further high-quality RCTs are warranted to confirm the authors’ results. [Orthopedics. 2015; 38(3):e178–e188.]

The authors are from the Department of Orthopedics, Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, China.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Chong Shen, MD, Department of Orthopedics, Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, China ( sc821@foxmail.com).

Received: January 29, 2014
Accepted: May 13, 2014

Abstract

Patient-specific instrumentation (PSI) has been introduced as a tool to increase the accuracy of total knee arthroplasty (TKA) compared with conventional instrumentation (CLI). However, previous studies have shown inconsistent results. The authors conducted a meta-analysis to compare the performance of PSI to CLI in TKA. PubMed, EMBASE, and Cochrane Central Register of Controlled Trials electronic databases were systematically searched to identify eligible trials published between 2000 and March 2014. Two reviewers independently assessed methodological quality according to the Cochrane Handbook. Subgroup analyses were performed based on the different study designs (randomized, controlled trial [RCT] vs non-randomized, controlled trial [non-RCT]), preoperative magnetic resonance imaging vs computed tomography, and systems of PSI to explore the source of heterogeneity. Fourteen studies (7 RCTs and 7 non-RCTs) involving 1906 patients were included. There were no statistical differences with respect to the outliers of mechanical axis, coronal femoral component, sagittal femoral component, femoral component rotation, operative time, blood loss, and length of hospital stay between PSI and CLI groups. The number of outliers in coronal tibial components (odds ratio, 2.29; 95% confidence interval, 1.20 to 4.35; P=.01) and sagittal tibial components (odds ratio, 1.67; 95% confidence interval, 1.16 to 2.42; P<.01) was significantly lower in the CLI group than in the PSI group. Based on the numbers available, the use of PSI compared with CLI was not likely to improve the accuracy of component alignment and treatment effects of TKA. Further high-quality RCTs are warranted to confirm the authors’ results. [Orthopedics. 2015; 38(3):e178–e188.]

The authors are from the Department of Orthopedics, Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, China.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Chong Shen, MD, Department of Orthopedics, Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, China ( sc821@foxmail.com).

Received: January 29, 2014
Accepted: May 13, 2014

Total knee arthroplasty (TKA) is generally considered the standard treatment for end-stage osteoarthritis of the knee when nonoperative treatments are no longer helpful. Accurate alignment may correlate with good clinical outcomes,1,2 whereas malalignment may result in early loosening, lower functional scores, abnormal stress, and a higher implant failure rate.3–5 In the major arthroplasty centers, the rate of implant malposition could reach 20% to 40% in patients who undergo TKA with conventional instrumentation (CLI).6–8 To limit implant malpositioning, smart tools such as computer-assisted surgery (CAS) and patient-specific instrumentation (PSI) have been developed. Although CAS has been reported to improve alignment and reduce variation,9 it prolongs operative time and increases cost with a risk of pin-related complications.10,11 One recent alternative has been the development of PSI, which uses anatomical data obtained primarily from preoperative computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting blocks to the patient’s individual anatomy. Patient-specific instrumentation has the potential to improve component accuracy, eliminate the alignment outliers, reduce variation in implant position, and save operative time for TKA instruments.

Despite its theoretical advantage, the effectiveness of PSI remains controversial. A few clinical studies reported that PSI resulted in better component alignment accuracy than conventional TKA instrumentation,12–14 whereas others reported that PSI did not surpass the accuracy of the CLI technique.15–18 The inconsistent results may be due to small sample sizes, diverse ethnicities, and different instruments.

Several reviews have reported that PSI may achieve a high degree of mechanical alignment compared with CLI.19,20 By using meta-analysis to synthesize the evidence and estimate the effect size, the current authors sought to evaluate the performance of PSI compared with CLI in patients undergoing TKA. The authors hypothesized that PSI may have better performance than CLI in TKA concerning (1) outliers, (2) operative time, (3) blood loss, and (4) length of hospital stay.

Materials and Methods

Data Sources and Searches

The electronic databases PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for articles published between 2000 to March 2014 using the following terms: patient-specific, patient-matched, custom cutting, custom fit, total knee arthroplasty, total knee replacement, TKA, and TKR. Reference lists of the relevant articles were manually searched for additional trials. Moreover, gray literature was searched using Google search engines and the registration centers of clinical trials ( www.chictr.org/cn; www.who.int/ictrp/en; www.clinicaltrials.gov; www.nrr.nhs.uk; www.actr.org.au; www.controlled-trials.com; www.trialscentral.org). No languages or publication statuses were restricted.

Inclusion Criteria

The following inclusion criteria were used: (1) randomized, controlled trial (RCT) or non-RCT; (2) performed in vivo; (3) adult patients underwent primary TKA; (4) compared PSI with CLI; (5) reported the outliers of at least 1 of the following outcomes: mechanical axis, coronal femoral component (CFC), coronal tibial component (CTC), sagittal femoral component (SFC), sagittal tibial component (STC), and femoral component rotation (FCR); and (6) included at least 40 patients. If multiple studies with overlapping data were identified, the authors included only the published report with the largest sample size. All studies that did not meet these criteria were excluded.

Data Extraction and Outcome Measures

Two reviewers (C.S., Z.-H.T.) independently extracted data using a standardized extraction form. Disagreements were resolved by discussion with a third reviewer (J.-Z.H.) until consensus was reached. The primary outcomes included the outliers of mechanical axis, CFC, CTC, SFC, STC, and FCR. The cutoff value for the outliers of mechanical axis, CFC, CTC, and FCR was 3°,12–18,21,22 whereas the cutoff values for the outliers of SFC and STC were between 3° and 7° according to different PSI systems.15,16,23,24 Secondary outcomes included operative time, blood loss, and length of hospital stay.

Quality Assessment

The Cochrane Collaboration’s tools were used to assess the risk of bias. The items for quality assessment involved 7 criteria: (1) sequence generation, (2) allocation concealment, (3) blinding of participants and personnel, (4) blinding of outcome assessment, (5) incomplete outcome data, (6) selective outcome reporting, and (7) other sources of bias. Each item of the included studies was classified as yes (low risk), no (high risk), or unclear (unclear risk).

Statistical Analysis

For dichotomous outcomes, the odds ratio (OR) and 95% confidence interval (CI) were calculated as the summary statistics. For continuous outcomes, mean and SD were used to calculate the weighted mean difference (WMD) with 95% CI in the meta-analysis. Heterogeneity between studies was quantified using P and I2 values.25 Heterogeneity was considered significant if the P value was less than .1 or the I2 value was greater than 50%. If heterogeneity was significant, meta-analysis was conducted using the random-effects model.26 Otherwise, the fixed-effects model was used. The fixed-effects model assumes that the only source of uncertainty derives from the within-study error. The random-effects model makes the assumption that different effects have the same source of uncertainty, plus an additional between-studies variance.

In addition, subgroup analyses (RCT vs non-RCT, MRI vs CT, different systems of PSI) were performed to look at more narrow subsets of the studies. Review Manager version 5.2 statistical software (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark) and STATA version 11.0 statistical software (Stata Corporation, College Station, Texas) were used for all analyses. Publication bias was examined by Egger’s linear regression test27 and Begg’s test.28

Results

Literature Search

Of the 401 potentially relevant studies identified through the literature search (Figure 1), 28 studies were retrieved for full-text assessment. After reviewing the full text, the authors found that 4 studies had overlapped data, 8 studies did not report the outcomes of interest, and 2 studies had a sample size less than 40. Hence, those 14 studies were excluded. Therefore, 14 studies (7 RCTs and 7 non-RCTs) with 1906 patients were included for meta-analysis.12–18,21–24,29–31

Flow chart of study selection based on the inclusion and exclusion criteria.

Figure 1:

Flow chart of study selection based on the inclusion and exclusion criteria.

Study Characteristics and Quality Assessment

The basic characteristics of the included studies are presented in Table 1. All of the included studies were published in English between 2012 and 2014. The sample sizes of the included studies ranged from 40 to 306. Among the 14 studies, 13 reported the mechanical axis,12,14–18,21–24,29–31 7 reported the CFC,15–17,21,23,24,31 7 reported the CTC,15–17,21,23,24,31 6 reported the SFC,15,16,21,23,24,31 6 reported the STC,15,16,21,23,24,31 4 reported the FCR,13,16,21,31 9 reported operative time,12,15,17,21–24,30,31 2 reported length of hospital stay,15,17 and 4 reported blood loss.15,17,21,22 The assessment of methodological quality is summarized in Table 2. Seven studies15–17,22,24,29 used the method of randomization in the trial design, whereas 2 studies16,29 used allocation concealment and 9 studies14–17,22–24,29,30 used blinding. A disagreement between the 2 reviewers regarding whether the outcome assessment was blinding in the study by Roh et al21 was resolved by the third reviewer.

Study CharacteristicsStudy Characteristics

Table 1:

Study Characteristics

Risk of Bias in Included Studies

Table 2:

Risk of Bias in Included Studies

Meta-analysis

Primary Outcomes: Mechanical Axis, CFC, CTC, SFC, STC, and FCR. Meta-analysis demonstrated no significant differences between the PSI and CLI groups in mechanical axis (OR, 0.99; 95% CI, 0.65 to 1.49; P=.94; I2= 56%; Figure 2), CFC (OR, 0.64; 95% CI, 0.39 to 1.06; P=.08; I2=0%; Figure 3), SFC (OR, 0.94; 95% CI, 0.67 to 1.33; P=.74; I2=15%; Figure 4), or FCR (OR, 0.84; 95% CI, 0.33 to 2.11; P=.70; I2=63%; Figure 5).

Forest plot of mechanical axis. Individual studies are listed on the left. The squares and horizontal lines correspond to the study-specific odds ratio and 95% confidence interval. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies crossing the midline, representing no significant difference between the 2 groups.

Figure 2:

Forest plot of mechanical axis. Individual studies are listed on the left. The squares and horizontal lines correspond to the study-specific odds ratio and 95% confidence interval. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies crossing the midline, representing no significant difference between the 2 groups.

Forest plot of coronal femoral component. Individual studies are listed on the left. Pooled treatment effects of each study are represented on the right. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies crossing the midline, representing no significant difference between the 2 groups.

Figure 3:

Forest plot of coronal femoral component. Individual studies are listed on the left. Pooled treatment effects of each study are represented on the right. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies crossing the midline, representing no significant difference between the 2 groups.

Forest plot of sagittal femoral component. Individual studies are listed on the left. Pooled treatment effects of each study are represented on the right. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies crossing the midline, representing no significant difference between the 2 groups.

Figure 4:

Forest plot of sagittal femoral component. Individual studies are listed on the left. Pooled treatment effects of each study are represented on the right. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies crossing the midline, representing no significant difference between the 2 groups.

Forest plot of femoral component rotation. Individual studies are listed on the left. Pooled treatment effects of each study are represented on the right. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies crossing the midline, representing no significant difference between the 2 groups.

Figure 5:

Forest plot of femoral component rotation. Individual studies are listed on the left. Pooled treatment effects of each study are represented on the right. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies crossing the midline, representing no significant difference between the 2 groups.

Subgroup analyses were performed to identify potential sources of heterogeneity. The authors found that type of study design (RCT vs non-RCT), method of bone modeling used preoperatively (MRI vs CT), and different systems of PSI (Signature, Biomet, Warsaw, Indiana; Patient-Specific Instruments, Zimmer, Warsaw, Indiana; Visionaire, Smith & Nephew, Memphis, Tennessee; and TruMatch, DePuy, Warsaw, Indiana) had no significant effect on the outcomes (Table 3).

Meta-analysis Including Subgroup AnalysisMeta-analysis Including Subgroup Analysis

Table 3:

Meta-analysis Including Subgroup Analysis

Meta-analysis showed that the outliers of CTC (OR, 2.29; 95% CI, 1.20 to 4.35; P=.01; I2=7%; Figure 6) and STC (OR, 1.67; 95% CI, 1.16 to 2.42; P=.006; I2=14%; Figure 7) were significantly lower in the CLI group than in the PSI group. However, subgroup analyses (MRI vs CT, different systems of PSI) revealed no significant differences between the 2 groups (Table 3).

Forest plot of coronal tibial component. Individual studies are listed on the left. The squares and horizontal lines correspond to the study-specific odds ratio and 95% confidence interval. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies exclusively to the right and does not cross the midline, representing a significant difference favoring conventional instrumentation.

Figure 6:

Forest plot of coronal tibial component. Individual studies are listed on the left. The squares and horizontal lines correspond to the study-specific odds ratio and 95% confidence interval. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies exclusively to the right and does not cross the midline, representing a significant difference favoring conventional instrumentation.

Forest plot of sagittal tibial component. Individual studies are listed on the left. The squares and horizontal lines correspond to the study-specific odds ratio and 95% confidence interval. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies exclusively to the right and does not cross the midline, representing a significant difference favoring conventional instrumentation.

Figure 7:

Forest plot of sagittal tibial component. Individual studies are listed on the left. The squares and horizontal lines correspond to the study-specific odds ratio and 95% confidence interval. The large diamond at the bottom represents the pooled treatment effect of all studies. It lies exclusively to the right and does not cross the midline, representing a significant difference favoring conventional instrumentation.

Secondary Outcomes: Operative Time, Blood Loss, Length of Hospital Stay, Publication Bias. Regarding operative time, data from 7 studies could be pooled. Two trials provided means but not SDs.17,21 Meta-analysis showed no significant difference between the 2 groups (WMD, −1.78; 95% CI, −4.45 to 0.90; P=.19) but with high heterogeneity (I2=89%). Subgroup analysis showed similar results (Table 3).

Four studies reported blood loss.15,17,21,22 Boonen et al15 reported that blood loss was significantly less in the PSI group than in the CLI group. However, the other 3 studies detected no difference between the groups.17,21,22 The current authors could not pool data for mean differences in mean total blood loss because only means were reported in these studies.

Two studies reported length of hospital stay.15,17 Neither study reported significant differences between the 2 groups.

The authors checked American Academy of Orthopaedic Surgeons disclosures for the authors of the assessed studies and found that authors of 5 studies were sponsored by companies.13,14,18,24,30 However, no publication bias was detected by Egger’s test (P=.965) and Begg’s test (P=.891).

Discussion

Although some studies have demonstrated that PSI has several advantages over CLI in component accuracy and elimination of outliers, controversy remains about their conflicting conclusions. Previously, only 1 systematic review compared the performance of PSI with CLI in patients receiving TKA.19 Recently, several RCTs have been updated.15,17,21,22,24,29 Therefore, the current authors conducted the first meta-analysis to compare the accuracy between the 2 technologies based on RCTs and non-RCTs.

The RCT is one of the most powerful tools of experimental study. People are allocated at random to receive one of several clinical interventions; the process of randomization is determined by neither the investigators nor the participants. In the current meta-analysis of 14 studies involving 7 RCTs and 7 non-RCTs with 1906 patients, there were no significant differences in the outliers of mechanical axis, CFC, SFC, FCR, operative time, blood loss, and length of hospital stay between the PSI and CLI groups. Notably, CLI performed superiorly in the outliers of CTC and STC. To verify the reliability of their conclusion, the authors also performed subgroup analysis according to the level of trial (RCT vs non-RCT), the method of bone modeling used preoperatively (MRI vs CT), and the different systems of PSI (Signature, Visionaire, Patient-Specific Instruments, and TruMatch). The results were consistent with the overall conclusion, except for CTC and STC.

The authors’ conclusion was in accordance with previous studies, which also proved that PSI did not improve accuracy in TKA.15–18,31 In recent RCTs, Roh et al21 and Chareancholvanich et al17 found no differences in the outliers of mechanical axis and femoral and tibial alignment between PSI and CLI groups. One explanation is the differences in surgical experience using these 2 instrumentations: surgeons have performed hundreds of TKAs using CLI but a far smaller number using PSI. Therefore, lack of familiarity with the PSI may affect results. Another reason is that the PSI is a pure geometric nature of the approach, not taking soft tissue status into account. With regard to the property of soft tissue, balancing a TKA is extremely important, especially in larger deformities. However, as static tests, preoperative MRI and CT for PSI do not take into account soft tissue laxity or tightness. No dynamic information is used to make the cutting blocks. In addition, many PSI techniques do not adjust well to significant flexion contractures or varus/valgus deformities due to lack of preoperative data about passive correction of the deformity. Several studies reported that the gap-balancing technique resulted in less alignment and femoral rotation outliers compared with the measured resection technique.32–34 Paternostre et al35 reported that a more concave side ligamentous release or more constraint was necessary than anticipated based on the PSI alignment result. They found that underestimation of deformity because of soft tissue results in an unsatisfactory amount of implant constraint. Computer assisted surgery, a technique for evaluation of soft tissue and bony resection in real time, could provide precise dynamic evaluation of knee alignment.36 When treating cases with significant flexion contractures or varus/valgus deformities, CAS techniques are a good choice because of their real-time evaluation.36,37

In the current study, there were more outliers of CTC and STC in the PSI group than in the CLI group. This can be explained by the nature of the technology. Chen et al23 indicated that the PSI tibial guide had a design flaw that pinned the cutting guide at a medial offset. Approaching the knee from the medial side essentially converts the cutting jig to a side cutting jig rather than the usual anterior reference jig. Failure to handle the saw tends to cause an oblique joint osteotomy, resulting in malpositioning of the tibial component. These results were confirmed by another study,16 which also found more outliers of CTC and STC in the PSI group. However, the subgroup analyses (MRI vs CT, different systems of PSI) were not significant between the 2 groups. This was likely due to the small number of studies and, hence, insufficient statistical power of the current study.

Some studies have proven that coronal malalignment can lead to a higher implant failure rate.3,38 This may result from asymmetric tibiofemoral tracking and subsequent abnormal stresses at the weight-bearing surfaces. A retrospective study showed that the subsequent loosening of implants in patients with coronal malalignment exceeding 3° occurred at a rate of 24%, compared with a rate of 3% in patients within 3° of neutral mechanical axis.39 To avoid these complications, some surgeons recommend a postoperative alignment within the range of 0°±3° of the mechanical axis.39,40 In the current study, the cutoff value for the outliers of mechanical axis, coronal component CTC and CFC alignment, and FCR was 3°. The pooled results showed that the use of PSI did not reduce the outliers of mechanical axis, coronal component CTC and CFC alignment, and FCR in TKA.

Component alignment in the sagittal plane was less reliable than that in the coronal plane.41 Optimal prosthetic alignment for TKA in the sagittal plane is uniform.41–43 For example, the target of the Signature was 3° for the femoral and tibial components, whereas the target of the Visionaire was 4° for the femoral components and 3° for the tibial components. Interestingly, subgroup analyses yielded similar results when using different PSI systems. Moreover, some authors claimed that bone models generated from MRI scans were dimensionally less accurate than those generated from CT scans.44 The current authors performed subgroup analysis based on the preoperative MRI or CT used for the planning of the cutting jigs. The results showed no differences in the outliers of mechanical axis, CFC, CTC, SFC, and STC between the MRI and CT subgroups.

In addition, the authors’ results showed that operative time was not decreased when using PSI in TKA. Manufacturers often claim that a reduction in operative time is an important superiority of PSI. The manufacturers surmised that after eliminating the bulk and complexity of CLI, operating room efficiency was enhanced, and thus intraoperative time was reduced. The opinion should be challenged while taking into account the time spent for preoperative planning and the additional cost for the MRI or CT scan. Moreover, some authors have raised concerns about the complications of CAS in TKA, which introduces pin-site loosening or fracture.11 However, none of studies included in the current meta-analysis reported the related complications.

It is a challenge to restore function and alignment when treating knee arthritis with CLI in patients who have an extra-articular deformity from a malunion or with retained hardware. A multicenter retrospective study by Thienpont et al45 demonstrated that the use of PSI systems to perform TKA in patients without access to the intramedullary canal because of extra-articular deformity or fixation devices improved function and restored limb alignment.

This meta-analysis has several potential limitations. First, the authors included studies with different levels of evidence (RCTs and non-RCTs). As a result of study design limitations, using non-RCTs may introduce a bias. Thus, they performed subgroup analyses for the RCTs and non-RCTs and found similar results. Second, allocation concealment was not used in most studies, which may introduce selection bias. Third, although subgroup analyses yielded similar results in different PSI systems, the nonuniform systems may bring bias. Fourth, 5 studies were sponsored by companies, and their results should be interpreted with caution.13,14,18,24,30 Funding source should be seriously assessed in systematic reviews. It has been reported that results are more likely to favor a product when an investigator has a financial interest in or funding from the product’s manufacturer.46 Due to these limitations, further studies are warranted.

Conclusion

The authors believe that PSI may have no advantage over CLI for patients undergoing TKA. It is likely that the use of PSI neither improves the alignment accuracy nor benefits the clinical outcomes of TKA, including operative time, blood loss, and length of hospital stay. Surgery with PSI as an alternative to conventional TKA should be used with caution. Perhaps PSI can be used where conventional instrumentation cannot, such as in previous femoral fractures with deformities or retained hardware. Further well-designed, large-sample RCTs with long follow-up are warranted.

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Study Characteristics

StudyCountryLevel of EvidenceStudy DesignNo. of KneesMales, %Mean Age (Range), yMean BMI (Range), kg/m2PSI SystemOutcomes

PSICLIPSICLIPSICLIPSICLI
Daniilidis & Tibesku12GermanyIIIRetrospective cohort15015663.350.666.1±8.865.0±9.231.7±4.630.3±5.3VisionaireaMA, OT
Heyse & Tibesku13GermanyIIIRetrospective cohort46VisionaireFCR
Ng et al14United StatesIIIRetrospective cohort10555SignaturebMA
Boonen et al15NetherlandsIRCT9090384469±8.065±8.830.329.5SignatureMA, CFC, CTC, SFC, STC, OT, MTBL, LHS
Victor et al16BelgiumIRCT6464333367 (52–87)66 (36–92)Signature, TruMatch,c Visionaire, Patient-Specific InstrumentsMA, CFC, CTC, SFC, STC, FCR
Chareancholvanich et al17ThailandIIRCT4040151069.5 (55–84)70.3 (53–85)27.7 (20.2–44.15)28.0 (22–39.6)Patient-Specific InstrumentsdMA, CFC, CTC, OT, MTBL, LHS
Barrack et al18United StatesIIIRetrospective cohort100100404364.8 (31.6–90.1)65.6 (42.8–91.0)SignatureMA
Roh et al21KoreaIIRCT424871070±7.270±5.127±4.227±2.7SignatureMA, CFC, CTC, SFC, STC, FCR, OT, MTBL
Chotanaphuti et al22ThailandIIRCT404069.7±5.569.3±5.525.0±2.425.0±2.1TruMatchMA, OT, MTBL
Chen et al23SingaporeIIProspective cohort2930311765±865±829.4±6.529.1±5.8Patient-Specific InstrumentsMA, CFC, CTC, SFC, STC, OT
Hamilton et al24United StatesIIRCT2626542768.1 (52–86)67.6 (51–88)30.9 (21.5–39.6)31.1 (22–38.4)TruMatchMA, CFC, CTC, SFC, STC, OT
Parratte et al29FranceIIRCT2020Patient-Specific InstrumentsMA
Barrett et al30United StatesIIProspective cohort6686383466.4±8.464.6±7.633.2±7.431.8±6.0TruMatchMA, OT
Marimuthu et al31AustraliaIIIRetrospective cohort11518568.3±8.867.6±9.730.8±8.630.6±5.4VisionaireMA, CFC, CTC, SFC, STC, OT

Risk of Bias in Included Studies

StudyRandom Sequence GenerationAllocation ConcealmentBlinding of ParticipantsBlinding of Outcome AssessmentIncomplete Outcome DataSelective ReportingOther Bias
Daniilidis & Tibesku12NoNoNoUnclearNoNoUnclear
Heyse & Tibesku13NoNoNoNoUnclearNoUnclear
Ng et al14NoNoNoYes (2 independent blinded investigators)UnclearNoUnclear
Boonen et al15Yes (random number generator)UnclearUnclearYes (2 independent reviewers)NoNoUnclear
Victor et al16Yes (not reported)Yes (sealed envelopes)YesYes (a blinded investigator)NoNoUnclear
Chareancholvanich et al17Yes (blocks-of-four method)UnclearUnclearYes (2 independent blinded investigators)NoNoUnclear
Barrack et al18NoNoNoNoUnclearNoUnclear
Roh et al21Yes (permuted block randomization program)UnclearUnclearUnclearNoNoUnclear
Chotanaphuti et al22Yes (not reported)NoNoYes (two independent blinded investigators)UnclearNoUnclear
Chen et al23NoNoNoYes (2 independent blinded investigators)UnclearNoUnclear
Hamilton et al24Yes (not reported)NoNoYes (a blinded investigator)UnclearNoUnclear
Parratte et al29Yes (systematic sampling method)Yes (sealed envelopes)YesYes (2 independent observers)NoNoUnclear
Barrett et al30NoNoNoYes (a blinded investigator)UnclearNoUnclear
Marimuthu et al31NoNoNoNoNoNoUnclear

Meta-analysis Including Subgroup Analysis

Subgroup and OutcomeNo. of StudiesNo. of PatientsOR (95% CI)PI2
Mechanical axis
  Overall results1318120.99 (0.65 to 1.49).9456%
  RCT76351.17 (0.76 to 1.78).481%
  Non-RCT611770.94 (0.49 to 1.82).8675%
  PSI based on MRI713130.96 (0.53 to 1.76).9070%
  PSI based on CT43741.25 (0.70 to 2.25).460%
  Signaturea46181.08 (0.51 to 2.28).8568%
  Patient-Specific Instrumentsb31792.07 (0.75 to 5.70).1641%
  TruMatchc32841.27 (0.66 to 2.45).4727%
  Visionaired26060.56 (0.27 to 1.15).1158%
CFC
  Overall results78740.64 (0.39 to 1.06).080%
  RCT55150.67 (0.32 to 1.41).2922%
  Non-RCT23590.76 (0.27 to 2.11).590%
  PSI based on MRI46070.63 (0.34 to 1.17).1418%
  PSI based on CT21421.04 (0.31 to 3.50).950%
  Signature22581.06 (0.45 to 2.45).890%
  Patient-Specific Instruments1390.24 (0.02 to 3.03).2755%
CTC
  Overall results78742.29 (1.20 to 4.35).017%
  RCT55152.62 (1.19 to 5.79).0227%
  Non-RCT23591.69 (0.55 to 5.22).360%
  PSI based on MRI46072.00 (0.87 to 4.62).100%
  PSI based on CT21421.20 (0.06 to 23.12).9159%
  Signature22581.28 (0.08 to 21.66).8664%
  Patient-Specific Instruments21391.38 (0.15 to 12.70).6624%
SFC
  Overall results67960.94 (0.67 to 1.33).7415%
  RCT44370.87 (0.58 to 1.31).5141%
  Non-RCT23591.16 (0.60 to 2.24).660%
  PSI based on MRI35290.76 (0.48 to 1.19).2239%
  PSI based on CT21421.62 (0.65 to 4.08).300%
  Signature22600.71 (0.27 to 1.89).0940%
STC
  Overall results67961.67 (1.16 to 2.42).00614%
  RCT44371.80 (1.10 to 2.93).0247%
  Non-RCT23591.51 (0.86 to 2.66).150%
  PSI based on MRI35291.42 (0.93 to 2.18).110%
  PSI based on CT21421.47 (0.57 to 3.75).430%
  Signature22601.23 (0.66 to 2.27).520%
FCR
  Overall results46090.84 (0.33 to 2.11).7063%
  RCT22151.17 (0.56 to 2.43).670%
  Non-RCT23940.39 (0.02 to 7.97).5487%
Visionaire23940.39 (0.02 to 7.97).5487%
Operative time
  Overall results71117−1.78 (−4.45 to 0.90).1989%
  RCT3300−1.66 (−4.75 to 1.44).4594%
  Non-RCT4817−0.81 (−2.25 to 0.62).2738%
  TruMatch3284−1.66 (−8.23 to 4.92).6294%
  Visionaire2606−0.91 (−3.51 to 1.69).4955%

10.3928/01477447-20150305-54

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