Is patient-specific pre-operative preparation feasible in a clinical environment? A systematic review and meta-analysis

Figures & data

Figure 1. PRISMA flowchart.

Table 1. Characteristics of included studies

Author - Year – Country	Study design	Procedure	Sample size	Intervention
Perry et al. [23] – UK	CS	Orbital reconstruction	21	Virtual planning of procedures and (for selected cases) inspection of physical models
Kockro et al. [11] – Singapore	CS	Brain tumour excision and vascular malformation repair	21	Planning using a virtual reality platform
Lo et al. [22] – Taiwan	CS	Fronto-orbital defects reconstruction	4	Rehearsals using physical models created through CAM – manufacturing of synthetic implants
Leong et al. [16] - USA	CS	Excision of sino-nasal lesion	22	Preoperative virtual planning and 18/22 intraoperative navigation
van Steenberghe et al. [50] - Switzerland, Belgium, Sweden	CS	Surgery for fully endentulous maxillae	27	Planning using virtual 3D images and construction of physical surgical guides and prostheses
Radecka et al. [49] - Sweden	CS	Nephrolithotripsy	8	Rehearsals with synthetic models manufactured using CAD
Gateno et al. [20] -USA	CS	CMF deformity repair	5	Virtual planning and CAM of physical surgical splints and templates – intraoperative navigation for some cases
Xia et al. [27] – USA	CS	CMF deformity repair	5	Virtual planning and CAM of physical surgical splints and templates – intraoperative navigation for some cases
Hislop et al. [44] - US	NRC	CAS	5	Virtual operation on simulator
Lu et al. [53] - China	CS	Insertion of laminar screws	9	Virtual planning and manufacturing of navigational template through rapid prototyping
Ng et al. [47] –Singapore	CS	Cerebral AV malformation	23	Planning using a virtual reality platform (Dextroscope, Volume Interactions, Singapore)
Dhanda et al. [17] - USA	CS	TMJ replacement	4	Physical models manufactured from virtual models – design and manufacturing of implants and guides
Fornaro et al. [29] - Switzerland	CS	Acetabular fracture repair	7	Virtual surgery and virtual adaptations of implants (prebending)
Qiu et al. [43] – China	CS	Cerebral gliomas resection	45	Planning using virtual reality platform (Dextroscope, Volume Interactions,Singapore)
Dong et al. [28] – China	CS	Extremity tumour resection	5	Virtual planning
Essig et al. [18] - Germany	CS	Mandibular reconstruction	3	Planning with virtual and physical models – surgical plates pre-bent during preparation
Ferrari et al. [48] - Italy	CS	Various general surgery ops	10	Planning of cutting planes using virtual models
Hu et al. [31] - China	CS	Acetabular fracture repair	7	Virtual planning of procedure and plate contouring
Tepper et al. [7] - US	CS	CMF reconstruction	2	Virtual surgery and inspection of physical models as well as preparation of physical surgical splints and implants
Derand et al. [16] – USA, Sweden	CS	Various CMF ops	4	Virtual planning of operation – design and manufacturing of plates, mesh and cutting guides
Kanzaki et al. [54] - Japan	CS	Thoracoscopic multi-subsegmentoctomy	11	Virtual planning
Kerens et al. [33] - Netherlands	CS	TKA	10	Virtual planning – design and manufacturing of cutting guides
Nam et al. [9] - US	NRC	TKA	Group 1 37 (41 knees) – group 2 38 (41 knees)	Computer Assisted Surgery (CAS) versus pre-operative planning and construction of Patient Specific Cutting guides (PSC)
Scolozzi [25] - Switzerland	CS	MF reconstruction	2	Virtual surgical planning – design and manufacturing of PS implants
Shen et al. [37] - China	CS		6	Semi-automatic virtual surgery and construction of virtual and real implants
Willaert et al. [45] - Australia	NRC	CAS	18 (3 excluded)	Virtual operations on simulator with the participation of the entire surgical team
Adolphs et al. [14] - Germany	CS	Dentofacial reconstruction	10	Virtual surgery with two types of splints – optimal splint manufactured with rapid prototyping
Desender et al. [41] – Belgium	NRC	EVAR	10 (1 excluded)	Virtual procedures on simulator
Hsu et al. [21] – USA	NRC	Dentofacial reconstruction	65	Virtual planning and CAM of physical surgical splints and templates – intraoperative navigation for some cases
Issa et al. [32] – USA	CS	TKA	84 (89 knees)	Computer generated preoperative plan and manufacturing of PS instrumentation and cutting blocks
Mandel et al. [57] - Brazil	CS	Various NS ops	18	Virtual planning
Pietsch et al. [35] - Austria	CS	TKA	50	Computational planning of surgery and designing of PS implants
Schweizer et al. [36] - Switzerland	CS	Malunited radial fracture repairs	6	Planning of cutting planes on virtual model – design and manufacturing of drill guides
Small et al. [38] - USA	RCT		36	Virtual procedures on VRS – patient specific implants designed and manufactured
Victor and Premanathan [39] - Belgium	CS	Knee osteotomies	14	Virtual planning and manufacturing of physical guides
Ayoub et al. [15] - Germany	RCT	Mandibular reconstruction	20	Planning using virtual and physical anatomical models – design and manufacturing of cutting guides
Franceschi et al. [30] – France	NRC	TKA	107	CT introduced in planning software for design and manufacturing of physical cutting guides
Gander et al. [19] – Switzerland, Netherland	CS		12	Virtual planning – design and manufacturing of PS implants. Intraoperative navigation for 7/12
Haq et al. [8] - UK, US	CS	TMJ ankyloses surgery	5	Interactive virtual surgery and construction of real cutting guides and implants
Leeuwen et al. [34] – Norway	CS	TKA	39 (42 knees)	Virtual planning – design and manufacturing of physical guides
Makiyama et al. [46] - Japan	CS	Lap renal surgery	13	Virtual operation on simulator
Fürnstahl et al. [10] - Switzerland	CS	Osteotomies of tibia plateau malunions	3	Semi-automatic virtual surgery and construction of real surgical guides
Isotani et al. [55] – Japan, USA	CS	Partial nephrectomy	20	Virtual surgery
Kusaka et al. [56] - Japan	CS	Kidney transplant	2	Planning with virtual and physical models
Li et al. [58] – China	CS	Revision lumbar discectomy	9	Virtual planning
Li et al. [51] – China	NRC	Management of dural A/V malformation	37	Group A: Preoperative planning using 3D printed models – Group B: routine practice.
Schepers et al. [24] -	CS	Fibula reconstruction	7	Virtual planning and CAM of physical guides for introducing implants
Steinbacher et al. [26] - USA	CS	CMF ops	6	Virtual surgery – design and 3d printing of guides, splints and implants
Vlachopoulos et al. [40] - Switzerland	NRC	Forearm osteotomies	14	Virtual surgery – design and manufacturing of physical drill and cutting guides

Figure 2. Above: Similarity between anatomy and surgical plan during rehearsal compared with real procedure. Size of circles is indicative of sample size. Below: Face and content validity of preoperative preparation processes.

Table 2. Accuracy of pre-operative preparation methods and immediate surgical results. Additional information regarding accuracy and clinical results can be found in figures 2, 4 and 5.

Study	Good clinical outcome - Major complications
Perry et al. [23]	4/5 (80%) selected cases presented had a satisfactory outcome
Kockro et al. [11]	4 illustrative cases presented Total tumour excision in 3/4 (75%) cases
Lo et al. [22]	Symmetry and normal orbital contours achieved in all cases No complications (29–55 months f/u)
Leong et al. [25]	NIP
van Steenberghe et al. [50]	24/27 (88.9%) implants pass one year control - Bruxism 6/27 (22.2%), 4/27 inflammation of the gingiva
Radecka et al. [49]	Complete clearance of stones 5/8 (62.5%) - Mucosal perforation 1/8 (12.5%)
Gateno et al. [20]	Deformities corrected at 6 week f/u
Xia et al. [27]	NIP
Hislop et al. [44]	Successful operations (0% residual vessel stenosis) 3/5 (60%)
Lu et al. [53]	77.8% improvement in symptoms at 9 months f/u No complications
Ng et al. [47]	Complete resection 23/23 (100%) - 4.3% had additional neurological deficit post-operatively - 1/23 severely disabled due to post-operative complications
Dhanda et al. [17]	1.43 cm average improvement in mouth openining
Fornaro et al. [29]	Anatomic or satisfactory reduction of fracture 7/7 (100%) - No serious complications
Qiu et al. [43]	Total tumour resection 33/45 (73.3%) - Decrease >10% of effective fibre of pyramidal tract 7/45 (15.6%)
Dong et al. [28]	Resection margins free of tumour in all cases
Essig et al. [18]	2/3 good results
Ferrari et al. [48]	No Information Provided (NIP)
Hu et al. [31]	NIP
Tepper et al. [7]	NIP
Derand et al. [16]	Surgeons’ opinion: Good correlation of plan and surgical steps Calculated reduction in operation time 30min
Kanzaki et al. [54]	No conversion to open Margins free of cancer 3 complications – prolonged air leak, needed pleurodesis
Kerens et al. [33]	All guides fitted well during real surgery Good stability in all cases at 6 weeks f/u No complications
Nam et al. [9]	Good alignment of lower limb for: CAS: 92.7% - PCS:70.7%
Scolozzi [25]	Satisfactory reconstruction 2/2 0 complications
Shen et al. [37]	Satisfactory or anatomical reduction in 5/6 (83.3%) cases - No complications (0%)
Willaert et al. [45]	NIP
Adolphs et al. [14]	NIP
Desender et al. [41]	NIP
Hsu et al. [21]	NIP
Issa et al. [32]	No complications
Mandel et al. [57]	NIP
Pietsch et al. [35]	Satisfactory outcome (overall axis within 3^o) 47/51 (94%)
Schweizer et al. [36]	Improvement of wrist ROM at 1 year f/u Increase of wrist strength by 10% on average No complications (no instability or crepitus)
Small et al. [38]	No differences in length of procedure or blood loss 1 complication in control group and 0 in PS preparation group
Victor and Premanathan [39]	13/14 healed well 0 complications
Ayoub et al. [15]	2 transplants failed due to venous thrombosis
Franceschi et al. [30]	Significant improvement of WOMAC score after 1 year 3.7% (4 cases) stiffness: 1 required change of insert and 3 cases arthrolysis
Gander et al. [19]	No re-operation needed No complications (no visual impairment, no sensation of foreign body)
Haq et al. [8]	Improvement of mouth opening 3/5 (60%) - No facial nerve injury (0%) - Re-operation in 1/5 cases
Leeuwen et al. [34]	10/41 HKA angle >3^o from neutral axis
Makiyama et al. [46]	NIP
Fürnstahl et al. [10]	All (100%) osteotomies healed in 3–6 months - Joint effusion 1/3 (33.3%)
Isotani et al. [55]	Resection margins negative for cancerous tissue No urological complications
Kusaka et al. [56]	NIP
Li et al. [58]	Surgeon’s opinion: anatomy accurately represented
Li et al. [51]	Shorter op time and blood loss in intervention group No difference in complication rates
Schepers et al. [24]	6/7 flaps survived (average f/u 9.7 months) 1.2–2mm discrepancy between pre and postoperative model
Steinbacher [26]	NIP
Vlachopoulos et al. [40]	All osteotomies healed after mean time of 3.6 months Increased ROM and grip strength for both groups

Figure 3. Quality assessment scores. a. NOQAS b. Three minute case series appraisal tool.

Figure 4. Meta-analysis comparing rehearsals and real procedures. a. Comparison of time to complete procedure b. Comparison of fluoroscopy time c. Comparison of fluoroscopy volume.

Figure 5. Meta-analysis of rehearsal compared with standard or other intervention (e.g. Nam et al patient specific preparation compared to computer assisted surgery). a. Time (min) to complete procedure. b. Linear translation (mm) of rehearsal outcome compared to the one of real procedure. Two different measured outcomes are included for Nam et al (for femoral and tibial compartment).

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