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62 (); 139-147
doi:
10.1016/j.jor.2025.03.044

Comparison of patient-specific instrumentation (PSI) versus conventional instrumentation (CI) in shoulder arthroplasties: A Meta-Analysis and Systematic Review

Yong Loo Lin School of Medicine, National University of Singapore, 10 Medical Drive, 7 Singapore, 117597, Singapore
Department of Orthopaedic Surgery, Tan Tock Seng Hospital, National Health Group, 11 Jln Tan Tock Seng, 308433, Singapore

⁎Corresponding author: Francis Jia Yi Fong. E0474171@u.nus.edu

Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Abstract

This study evaluates the effectiveness of patient-specific instrumentation (PSI) versus conventional instrumentation (CI) in shoulder arthroplasties. Accurate glenoid component placement is crucial for successful shoulder replacements, and PSI offers the potential to improve this accuracy.

Electronic database search of PubMed, Embase, Scopus, Web of Science and Cochrane was performed on April 10, 2024, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines for scoping reviews. The searches were conducted using the keywords relating to “shoulder arthroplasty” and “three-dimensional printing”. No restrictions were placed on the date of publication.

10 clinical studies involving 4092 patients, comparing PSI and CI were included. The results show that PSI generally improves radiological outcomes, with lower anterior-posterior offset errors, longer screw lengths, and near statistically significant reductions in version, inclination, and superior-inferior offset errors. However, there was no significant difference between PSI and CI in terms of operative duration, complication rates, or short-term patient-reported outcomes such as the Constant Murley Score.

While PSI did not significantly reduce short-term complications or alter patient-reported outcomes, it demonstrated a promising potential to enhance glenoid component positioning. Accurate placement of the glenoid component is crucial for long-term success, and PSI may reduce postoperative complications such as glenoid loosening. However, the lack of long-term follow-up in most studies limits the ability to fully assess these benefits.

The study also highlights the variability in PSI design and calls for standardized protocols to improve data consistency and accuracy.Longer follow-up studies are recommended to better assess the impact of PSI on long-term outcomes. In conclusion, PSI may improve radiological outcomes without increasing surgical complexity, representing a promising alternative to CI in shoulder arthroplasty.

II.

Keywords

Orthopedics
3D printing
Shoulder arthroplasties
Patient-specific instrumentation
Conventional instrumentation
Patient-specific outcomes
Radiological parameters
1

1 Introduction

Total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) are commonly performed procedures for management of rotator cuff arthropathy and proximal humerus fractures.1 A critical factor for the success and longevity of shoulder arthroplasties is the accuracy of the positioning and fixation of the glenoid component. Malalignments of the glenoid component can significantly increase post-operative complications, including early loosening, poor function and instability.2–5 Given the variability in glenoid sizes and exposure of the glenoid face across individuals, achieving ideal glenoid placement is often challenging.6

Recent advancements in three-dimensional (3D) printing technology have introduced patient-specific instrumentation (PSI), which has the potential to enhance the accuracy and precision of the glenoid component placement.7–9 However, the evidence on the clinical utility of PSI in shoulder arthroplasties is mixed. Some studies suggest that PSI improves accuracy,10–12 while others indicate that it may not offer significant improvement over conventional instrumentation (CI).13

Previous meta-analyses have attempted to compare the PSI against CI, however both cadaveric and clinical studies were included in the inclusion criteria.9 In light of the growing interest and literature surrounding the use of PSI in shoulder arthroplasties, it is noteworthy to conduct an updated meta-analysis focusing exclusively on clinical studies. The primary aim of this review is to compare the clinical accuracy of PSI against CI in shoulder arthroplasties.

2

2 Methods

2.1

2.1 Search strategy

The following study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement.14 An electronic database search of PubMed, Embase, Scopus, Web of Science and Cochrane Central Register of Controlled Trials was performed on April 10, 2024 using the keywords: patient specific instrumentation and total shoulder replacement.

2.2

2.2 Data assessment, inclusion and exclusion criteria

Abstracts were screened to remove duplicates and selected based on the predetermined inclusion criteria (Table 1). The full texts of the remaining studies were further analyzed. Reference lists of included articles were hand searched to identify further studies for analysis. Any discrepancies were resolved by achieving a consensus with a third author (MYGJ).

Table 1 Inclusion and exclusion criteria.
Inclusion Exclusion
-Clinical studies-Studies comparing patient specific instrumentation against conventional instrumentation in reverse shoulder or anatomical shoulder arthroplasty -Studies which do not have a comparison group-Biomechanical studies-Cadaveric Studies-In vitro studies-Animal Studies-Review articles, case reports, conference papers and letters which do not contain original data-Non-English language articles

Clinical studies comparing the use of PSI against CI in shoulder arthroplasties were selected. The Newcastle–Ottawa Quality Assessment Scale was used for the assessment of the quality of non-randomized studies in meta-analyses.15 All 6 included studies were of good quality according to the Newcastle-Ottawa scale, with a range of 7–9 points (Supplementary Figure). The RoB-2 scale was used for the assessment of the quality of randomized controlled trials.16 Three studies were low in overall risk of bias,17–19 one study was deemed to have moderate risk of bias due to potential bias from missing outcome data.7

2.3

2.3 Data collection

Data from included studies were extracted independently by FFJY and JDO using a standardized protocol and reporting form. The extracted data included: study characteristics (year of study, study design, follow-up duration, patient demographics), duration of operation, complication rates, radiological outcomes (version, inclination, anterior-posterior and superior-inferior offset) and patient reported outcome measures. We also extracted the following patient-reported outcomes at baseline and at the last follow-up. When means and standard deviation data were unavailable, conversions of data were performed using previously established models by Wan et al.20 We used the following definitions for radiological outcomes7,19.1.Version error (°): Defined as the difference between the planned version angle against the actual version angle measured using the Friedman method.212.Inclination error (°): Defined as the difference between the planned inclination angle against the actual inclination angle. The inclination angle was measured by calculating the angle perpendicular to the vertical line from the center of the glenoid to the medial border of the scapula in the coronal plane CT images.3.Anterior-posterior offset (mm): Defined as the difference in the displacement of the implant centroid between the planned and actual implant positions in the transverse plane.4.Superior-inferior offset (mm): Defined as the difference in the displacement of the implant centroid between the planned and actual implant positions in the sagittal plane.

2.4

2.4 Statistical analysis

Mean difference for continuous outcomes were extracted from selected studies. Heterogeneity among studies was assessed using the I2 statistic, interpreted according to definitions provided by the Cochrane Handbook, where an I2 value of 0 %–50 % represents that heterogeneity might not be important, and 50 %–100 % may represent heterogeneity.22 Statistical significance was considered at the p ≤ 0.05 level. All statistical analyses were made assuming a two-sided test at the 5 % level of significance using the Review Manager version 5.3 (Revman, Cochrane Information Management System) software. Random-effects models were utilized in all meta-analysis.

3

3 Results

A systematic search of the literature using our search strategy yielded a total of 7377 articles with 2828 remaining after the removal of duplicates. 2773 articles were excluded based on the title and abstract review. The remaining 55 articles underwent full-text review, of which 10 articles were subsequently included in the meta-analysis (Fig. 1). 5 articles were retrospective studies,23–27 1 prospective study28 and 4 randomized control trials.7,18,19,29 A summary of the study characteristics can be found in Table 2.

Prisma diagram.
Fig. 1 Prisma diagram.
Table 2a Demographic data of studies included.
Author Study type Country Total shoulder/patients Male Type of scan used for preoperative planning Average age BMI Follow-up time Type of surgery PSI CI
Heylen et al. 20165 Case control Belgium 36 13 CT scan 70.5 (9.7) NR NR 6 Anatomic, 12 Reverse 18 18
Kwak et al. 20228 P Korea 39 PSI: 4CI:5 CT scan PSI: 74 (6)CI: 77 (6) NR NR Reverse 19 20
Hwang et al. 20236 R USA 178 PSI: 46CI: 30 CT scan PSI: 69.1 (7.6)CI: 68.1 (6.4) PSI: 30.4 (6.9)CI: 31.8 (8.3) 2 years Reverse 122 56
Yung et al. 202310 R Hong Kong 73 PSI: 3CI:3 CT scan PSI: 75.8 (8.9)CI: 76.8 (8.2) PSI: 27.3 (4.4)CI: 26.0 (6.2) PSI: 2.1 (1.1)CI: 3.5 (1.7) Reverse 31 42
Boekel et al. 20231 RCT Australia 47 PSI: 16CI: 10 CT scan PSI: 69.3 (6.8)CI: 69.8 (7.3) PSI: 31.8 (5.9)CI: 29.6 (6.7) 2 years Reverse 24 23
Elsheikh et al. 20223 R United Kingdom 53 PSI: 7CI: 10 CT scan PSI: 68 (50–89)CI: 69 (47–77) NR PSI: 39 months (35–65 months)CI: 53 months (24–86 months) Reverse 18 35
Hendel et al. 20124 RCT USA 31 NIL NR NR Within first 4 months Anatomic 15 16
Dasari et al. 20242 RCT USA 36 PSI: 13CI: 12 PSI: 60.2 (7.7)CI: 61.0 (8.8) NR 1 year Anatomic 19 17
Navarro et al. 20239 R USA 3553 PSI: 200CI: 1439 CT scan PSI: 70.7 (8)CI: 70.0 (8.4) PSI: 30 (5.6)CI: 29.8 (6) At least 2 years Anatomic: 1832Reverse:1721 400 3153
Iannotti et al. 20157 RCT USA 46 NR CT scan NR NR NR Anatomic 25 21
Table 2b Morphology and details of studies included.
Author Study type Country Total shoulder/patients Male Type of scan used for preoperative planning Average age BMI Follow-up time Type of surgery PSI CI
Heylen et al. 20165 Case control Belgium 36 13 CT scan 70.5 (9.7) NR NR 6 Anatomic, 12 Reverse 18 18
Kwak et al. 20228 P Korea 39 PSI: 4CI:5 CT scan PSI: 74 (6)CI: 77 (6) NR NR Reverse 19 20
Hwang et al. 20236 R USA 178 PSI: 46CI: 30 CT scan PSI: 69.1 (7.6)CI: 68.1 (6.4) PSI: 30.4 (6.9)CI: 31.8 (8.3) 2 years Reverse 122 56
Yung et al. 202310 R Hong Kong 73 PSI: 3CI:3 CT scan PSI: 75.8 (8.9)CI: 76.8 (8.2) PSI: 27.3 (4.4)CI: 26.0 (6.2) PSI: 2.1 (1.1)CI: 3.5 (1.7) Reverse 31 42
Boekel et al. 20231 RCT Australia 47 PSI: 16CI: 10 CT scan PSI: 69.3 (6.8)CI: 69.8 (7.3) PSI: 31.8 (5.9)CI: 29.6 (6.7) 2 years Reverse 24 23
Elsheikh et al. 20223 R United Kingdom 53 PSI: 7CI: 10 CT scan PSI: 68 (50–89)CI: 69 (47–77) NR PSI: 39 months (35–65 months)CI: 53 months (24–86 months) Reverse 18 35
Hendel et al. 20124 RCT USA 31 NIL NR NR Within first 4 months Anatomic 15 16
Dasari et al. 20242 RCT USA 36 PSI: 13CI: 12 PSI: 60.2 (7.7)CI: 61.0 (8.8) NR 1 year Anatomic 19 17
Navarro et al. 20239 R USA 3553 PSI: 200CI: 1439 CT scan PSI: 70.7 (8)CI: 70.0 (8.4) PSI: 30 (5.6)CI: 29.8 (6) At least 2 years Anatomic: 1832Reverse:1721 400 3153
Iannotti et al. 20157 RCT USA 46 NR CT scan NR NR NR Anatomic 25 21

A total of 4092 patients were included in the study. 691 patients underwent shoulder arthroplasty via PSI while the remaining 3401 patients underwent shoulder arthroplasty via CI. Out of the 10 included studies, 5 studies only included patients underwent reverse shoulder arthroplasty,24–26,28,29 3 only included anatomic shoulder arthroplasty7,18,19 and the remaining 2 included both anatomical and reverse shoulder arthroplasty.23,27

3.1

3.1 Mean operative duration

In four studies involving 3726 patients, the mean operative duration for patients that underwent PSI, involving 473 patients, was 119.97 ± 38.23 while the mean operative duration for patients that underwent CI, involving 3253 patients, was 111.26 ± 38.97. The pooled difference in the means of operative duration between PSI and CI, was analyzed, giving a pooled estimate of 3.66 (95 % CI: −10.76 to 18.07; p = 0.48; I2 = 60 %) (Fig. 2). These findings suggest that the operative duration was comparable between PSI and CI.

Operative duration.
Fig. 2 Operative duration.
3.2

3.2 Complication rates

The pooled numbers of patients who had postoperative complications following PSI from six studies involving 610 patients and following CI from six studies involving 3325 patients were 74 and 592, respectively.

In five studies involving 4015 patients, the estimated pooled odds ratio of patients who had postoperative complications between PSI and CI, was 0.94 (95 % confidence interval [CI], 0.84–1.04; p = 0.15; I2 = 0 %) (Fig. 3). These findings suggest that there is no significant difference in the rates of postoperative complications between the PSI and CI.

Complication rates.
Fig. 3 Complication rates.
3.3

3.3 Patient reported outcome measures

3.3.1

3.3.1 Constant Murley Score

In 3 studies involving 278 patients, the mean CMS for patients that underwent PSI, involving 164 patients, was 33.95 ± 18.13 while the mean CMS for patients that underwent CI, involving 114 patients, was 33.63 ± 12.05. The pooled difference in the means of CMS between PSI and CI, was analyzed, giving a pooled estimate of −1.63 (95 % CI: −14.13 to 10.87; p = 0.63; I2 = 62 %) (Fig. 4).24,29,26

Constant murley score (CMS).
Fig. 4 Constant murley score (CMS).

Although there was insufficient data to be extracted for a meta-analysis, it is noteworthy to mention that there was no significant differences observed in the Visual Analog Scale for pain24,26 and American Shoulder and Elbow Surgeons scale26,29 between PSI and CI. However, the results were mixed for the Oxford Shoulder Score. After 2 years, Boekel et al. reported that patients treated with PSI had a significantly higher score while Elsheik et al. did not report any significant difference. Thus, the findings suggest that overall PSI and CI provide comparable short-term patient reported outcomes.

3.4

3.4 Analysis of angles

3.4.1

3.4.1 Version error subgroup analysis

The mean version error for patients that underwent PSI from 4 studies involving 78 patients was 3.31 ± 2.81. The mean version error for patients that underwent CI from 4 studies involving 74 patients was 4.56 ± 3.40. The difference in the means of version error between PSI and CI from the 4 studies, involving 152 patients, was analyzed, giving a pooled estimate of −0.95 (95 % CI: −2.14 to 0.24; p = 0.8; I2 = 0 %) (Fig. 5).7,18,19,28 In a subgroup analysis of 3 studies comparing 113 patients who underwent anatomical shoulder arthroplasty, the pooled difference between PSI and CI was −1.25 (95 % CI: −4.13 to 1.63; p = 0.20; I2 = 28 %) (Fig. 5).7,18,19 These findings suggest that patients who underwent PSI nearly had a significantly lower version error compared to CI.

Version subgroup analysis.
Fig. 5 Version subgroup analysis.
3.4.2

3.4.2 Anterior-posterior (AP) error subgroup analysis

The mean AP error for patients that underwent PSI from 3 studies involving 59 patients was 1.09 ± 1.11. The mean AP error for patients that underwent CI from 3 studies involving 57 patients was 1.90 ± 1.30. The difference in the means of AP error between PSI and CI from the 3 studies, involving 116 patients, was analyzed, giving a pooled estimate of −0.74 (95 % CI: −1.32 to −0.16; p = 0.03; I2 = 0 %) (Fig. 6).7,19,28 In a subgroup analysis of 2 studies comparing 77 patients who underwent anatomical shoulder arthroplasty, the pooled difference between PSI and CI was −0.68 (95 % CI: −2.63 to 1.28; p = 0.14; I2 = 0 %).7,19 These findings suggest that patients who underwent PSI nearly had a significantly lower AP error compared to CI.

AP offset subgroup analysis.
Fig. 6 AP offset subgroup analysis.
3.4.3

3.4.3 Inclination error subgroup analysis

The mean inclination error for patients that underwent PSI from 5 studies involving 96 patients was 3.55 ± 5.64. The mean inclination error for patients that underwent CI from 5 studies involving 92 patients was 6.77 ± 8.12. The difference in the means of inclination error between PSI and CI consisting of 5 studies, involving 188 patients, was analyzed, giving a pooled estimate of −2.99 (95 % CI: −6.55 to 0.57; p = 0.08; I2 = 67 %) (Fig. 7).7,18,19,27,28

Inclination error subgroup analysis.
Fig. 7 Inclination error subgroup analysis.

Although there was insufficient data to be extracted for a meta-analysis, it is noteworthy to mention that there are currently conflicting results on the differences of the superior-inferior offset between PSI and CI. Hendel et al. did not find any clinical significance,7 while Iannotti et al.19 and Kwak et al.28 reported that PSI offered better superior-inferior offset results when compared to CI.

3.4.4

3.4.4 Difference in the length of screws

The mean length of screws for patients that underwent PSI from 2 studies involving 100 patients was 39.23 ± 9.30 mm. The mean length of screws for patients that underwent CI from 2 studies involving 124 patients was 30.05 ± 7.88. The difference in the mean length of screws between PSI and CI consisting of 2 studies, involving 224 patients, was analyzed, giving a pooled estimate of 8.51 (95 % CI: 0.40 to 16.61; p = 0.04; I2 = 85 %) (Fig. 8).25,28 A subgroup analysis showed no significant differences in the independent length of the superior and inferior screw between PSI and CI.

Difference in the length of screws.
Fig. 8 Difference in the length of screws.
4

4 Discussion

Given the growing interest of patient specific instrumentation (PSI) in orthopedic surgery, this paper seeks to investigate whether the use of PSI in both anatomical and reverse shoulder arthroplasty improves clinical outcomes when compared to conventional instrumentation (CI). Our findings indicate that PSI generally leads to improved radiological outcomes, including significantly longer screw lengths, lower anterior-posterior offset error and near statistically significant reductions in inclination, version and superior-inferior offset errors. Importantly, the use of PSI did not increase operative duration or short-term complications rates suggesting that PSI does not add complexity to shoulder arthroplasties. Despite these advantages, no differences were observed amongst the short-term patient-reported outcome measures (PROM) between PSI and CI.

Accurate glenoid component positioning is paramount for the long-term success of shoulder arthroplasties. The misalignment of the glenoid baseplate or inadequate screw purchase in the bone often results in post-operative complications. A common complication that arises from this is the loosening of the glenoid component which accounts for 13 % of revision surgeries.29–31 This issue is exacerbated by the technical challenge of exposing the glenoid, as there is no reliable intra-operative landmark to help determine the glenoid morphology and scapular plane.32–34

Currently, using conventional instrumentation to position the glenoid component results in significant fluctuations in accuracy.35–37 These variations are influenced by the surgeon's experience12 and the degree of patient's bone loss.38,39 Biomechanical studies suggest that the closer the post-operative radiological values are to the planned operative radiological values, the lower the rates of long-term post-operative complications.2,40 Theoretically, PSI improves accuracy during the positioning of the glenoid component by providing a template tailored to an individual's anatomy, mitigating the aforementioned factors. Our findings support this claim, showing that the pooled mean of offset errors from the planned operative values is wider with CI (1.90°–6.77°) compared to PSI (1.09°–3.55°).

This paper acknowledges that some radiological parameters such as version, inclination and superior-inferior offset were only near statistical significance. We hypothesize several confounding factors affecting their p-values. Firstly, the lack of standardization and consensus on a universal protocol for designing PSI in shoulder arthroplasties results in a wide variety of guide designs being used in clinical studies. This variability affects the accuracy and heterogeneity of the collected data, as reflected in the high I2 values in the inclination and superior-inferior offset. Secondly, the offset errors also depend on a surgeon's ability to consistently identify landmarks to correctly position the guidewire on the glenoid surface and ream in line with the guide pin. Deviations in these steps can lead to further inaccuracies.27,37

While the subgroup analysis of superior and inferior screw lengths did not show independent differences between the two treatment modalities, the overall combined effect of these screw lengths was statistically higher in PSI compared to CI. Biomechanical studies have shown that longer screw lengths result significantly better baseplate fixation, stronger stability of the glenoid component and reduced the risk of glenoid loosening.41,42 Our findings suggests that PSI is potentially able to achieve stronger stability of the glenoid baseplate due to the longer screw lengths compared to CI, thereby potentially reducing the risk of glenoid loosening.

Lastly, our study found that there were no statistical differences in PROM and complication rates between PSI and CI. Parsons et al. found that the incidence of patients reporting satisfactory PROM was significantly affected by post-operative complications such as scapular notching.43 Therefore, as there were no significant differences in complication rates between PSI and CI, it is reasonable to expect no significant differences in PROM. A possible explanation for this is that the current follow-up period in the included studies is too short to fully capture complications related to radiological differences in glenoid baseplate positioning between PSI and CI. The estimated mean follow-up time for the included studies for complication rates was 2.78 years while the mean follow-up time for PROM was 2.80 years. However, current literature suggests that longer follow-up periods of at least six years are required to accurately assess the incidence of complications associated with glenoid baseplate malalignment, such as scapular notching.44 Hence, studies with longer follow-up durations are encouraged to improve the accuracy of these findings.

5

5 Limitations

We acknowledge the following limitations of our study. Firstly, there is a lack of standardization and consensus on a universal protocol for designing PSI in shoulder arthroplasties. This leads to a wide variety of guide designs used in clinical studies. We recommend that clinicians and professional societies collaborate to establish a standardized protocol, which would help reduce variability and improve the accuracy of PSI. Secondly, the mean follow-up duration of the included studies may be insufficient to observe the full extent of post-operative complications. We advocate for further research with follow-up durations of at least five years to more accurately capture the post-operative complications related to differences in radiological parameters. Finally, we recognise that some of our forest plots included only three studies due to the limited number of clinical papers currently published. To enhance the statistical accuracy and reliability of our findings, more studies are needed.

6

6 Conclusion

Although currently there are no significant differences in short term patient-reported outcome measures, PSI has generally shown significantly better radiological outcomes compared to CI. Longer-term follow-up studies are required to accurately discern the complication rates and patient-reported outcomes due to these radiological differences. Since PSI does not significantly impact operation times or short-term complications, it represents a promising alternative to CI.

Ethics statement

All procedures were performed in compliance with relevant laws and institutional guidelines. As no human subjects were included nor recruited during the course of this scoping review, an IRB approval was not required.

Contributions

Conception and design: MYGJ.

Analysis and interpretation of the data: FFJY, JDO and YLM.

Drafting of the article: FFJY, JDO and MYGJ.

Critical revision of the article for important intellectual content: FFJY, JDO and MYGJ.

Final approval of the article: MYGJ.

Financial Disclosure

This research did not receive any source of funding

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