Level of evidence and Coleman methodology scale score for included studies

Transcription

1 Table 4 Level of evidence and Coleman methodology scale score for included studies Investigator Evidence Level Study Type Lee M et al (44) II Prospecti ve ive study Jowett CRJ et al IV Case (45) Biz C et al (46) IV Case Brogan K et al (47) III Retrospe ctive ive study Díaz Fernández et al (48) Kurashige T et al (49) IV IV Case Case Lam P et al (50) II Prospecti ve ive study Lucas y Hernandez IV Case et al (51) Díaz Fernández et al (30) IV Case Cervi et al. (31) IV Case Rodríguez-Reyes G, IV Case et al. (32) Brogan et al. (3) IV Case Faour-Martín et al. IV Case (34) Vernois et al. (19) IV Case Radwan et al. (25) II Prospecti ve ive study, group randomiz ation De Lavigne et al. IV Case (27) Valles-Figueroa et al. (20) IV Case Luria et al. (21) IV Case Year HV Grade Procedure Patients (Feet)* Average Follow- Up CMS Score 2017 Moderate 6 months 54 to severe PECA (I) versus Open Scarf/Akin osteotomies (II) 50 (50 25 PECA/25 Scarf and Akin) 2017 Moderate PECA 87 (120) 25 months Mild to severe 2016 Mild to Reverdin-Isham and Akin percutaneous osteotomies Percutaneous Chevron (I) versus Open distal Chevron (II) 2016 Severe Percutaneous double (closure proximal and Akin ) or Percutaneous triple (closure proximal, Reverdin-Isham and Akin ) 2016 Severe Percutaneous double (closure proximal and Akin ) 2016 Mild to (I) Scarf and Akin osteotomies (II) PECA 80 (80) 48 months (81 49 percutaneous/ 32 open) (I) 31 months (II) 37 months (50) 24 months (17) 22 months (60 27 Scarf and Akin/ 33 PECA) 26 weeks Moderate Percutaneous Chevron 38 (45) 59.1 months Moderate Percutaneous double 42 (45) months 48 to severe surgical technique (Reverdin- Isham and base) 2014 NR Reverdin-Isham 213 (184) 5-29 months Mild to 2014 Mild to severe 2013 Mild to 2013 Mild to 2012 Mild to Reverdin-Isham 11 (20) 6-12 months 36 Percutaneous Chevron 35 (45) 6-17 months 45 Bösch 87 (115) 10 years 53 Percutaneous Chevron Magnan (I) versus Chevron (II) 341 (408) Not reported (64-31 Magnan/33 Chevron) 12 months Severe Percutaneous double surgical technique(percutaneou s Chevron and M1 base) 6 (6) months Mild to Magnan 40 (58) 6-12 months NR Bösch 23 (23) 12 months 22

2 Table 4 Level of evidence and Coleman methodology scale score for included studies Investigator Evidence Level Study Type Bauer et al. (28) IV Prospecti ve study, case Maffulli et al (24) III Retrospe ctive ive study Bauer et al. (26) II Prospecti ve multicent er Siclari et al. (33) IV Case Barragan-Hervella et al. (35) IV Case Magnan et al. (22) IV Case De Prado et al. IV Case (29) A. Roth et al. (23) III Retrospe ctive, ive study Year HV Grade Procedure Patients (Feet)* Average Follow- Up 2010 Mild to Reverdin-Isham 82 (104) 24 months (12-40) 2009 Mild to 2009 Mild to 2009 Mild to Bösch (I) versus Scarf (II) 72 (72-36 Böch/36 Scarf) CMS Score months 51 Reverdin-Isham 168 (189) 12 months 62 Bösch and arthroscopic lateral release 49 (59) 31.5 (range, 12 to 48) months 2008 Mild Reverdin-Isham 29 (29) 6 months Mild to 2003 Mild to 1996 Mild to Magnan 82 (118) 36 months 46 Reverdin-Isham 64 (64) months 48 Bösch (I) versus Kramer (II) 105 ( Böch/36 Kramer) 48 Not reported 44 Abbreviations: CMS, Coleman methodology scale; HV, hallux valgus; M1, first metatarsal; PECA, percutaneous chevron/akin ; NR, not reported. *Number of patients (number of feet).

3 Table 5 Summary of orthopedic surgical studies and recommendation grade for or against percutaneous surgical intervention for hallux valgus Procedure Studies [n (%)] Level I Level II Level III Level IV, V Grade Recommendation Reverdin-Isham 7 (27) B For intervention Percutaneous Chevron 7 (27) B For intervention Magnan 3 (12) B For intervention Bösch 5 (19) B/C For intervention Percutaneous double 4 (15) C For intervention Total 26 (100)

4 Table 6 Scores and radiographic results from included studies Score AOFAS HVA ( ) IMA ( ) DMAA ( ) Investigator Procedure Preop Postop Preop Postop Preop Postop Preop Postop Lee M et al (44) Jowett CRJ et al (45) Biz C et al (46) Brogan K et al (47) Díaz Fernández et al (48) Kurashige T et al (49) Percutaneous double surgical technique (Reverdin- Isham and base) NR NR Reverdin-Isham NR NR NR NR NR NR Lam P et al (50) Lucas y Hernandez et al (51) Díaz Fernández (30) Cervi et al. (31) Rodríguez- Reyes et al. (32) Brogan et al. (3) Faour-Martín et al. (34) Vernois et al. (19) Radwan et al. (25) De Lavigne et al. (27) Valles- Figueroa et al. (20) Luria et al. (21) Bauer et al. (28) Maffulli et al (24) PECA (I) versus open Scarf/Akin (II) (I) 61.3 (II) 58.5 (I) (II) 83.0 (I)31.4 (II)31.2 (I)7.6 (II)10.1 (I)15.6 (II)15.7 (I)6.4 (II)7.6 PECA NR NR Reverdin-Isham and Akin percutaneous osteotomies Percutaneous chevron (I) versus Open distal chevron (II) Percutaneous double (closure proximal and Akin ) or Percutaneous triple (closure proximal, Reverdin-Isham and Akin ) Percutaneous double (closure proximal and Akin ) (I) Scarf and Akin osteotomies (II) PECA Percutaneous Chevron Osteotomy (I) MOXFQ score: (II) MOXFQ score: 157 (I) MOXFQ score: 39.1 (II) MOXFQ score: 49.2 (I) 26.6 (II) 30.8 (I) 10.4 (II) 9.9 (I) 11.7 (II) 13.4 (I) 6.8 (II) 6.7 NR (I) 9 (II) NR NR NR NR (I) 58 (I) 83 (I) 31 (I) 10.1 (I) 15.7 (I) 7.6 NR NR (II) 61 (II) 89 (II) 31 (II) 7.6 (II) 15.6 (II) Reverdin-Isham NR NR NR (I) 1 (II) 11 Percutaneous Chevron MOXFQ score: MOXFQ NR NR score: Bösch Percutaneous Chevron NR NR NR 92 Magnan (I) versus Chevron (II) (I) (II) (I) (I) (I) (I) (I) 7.79 NR NR (II) (II) (II) (II)12.03 (II) Percutaneous double NR NR surgical technique(percutaneous Chevron and M1 base) Magnan 41.4 NR NR 13.1 NR Bösch NR NR NR 11.1 NR 5.7 NR NR Reverdin-Isham Bösch (I) versus Scarf (II) (I) (II) (I) 85 (II) 86 (I) 27 (II) 28 (I) 17 (II) 20 (I) 15 (II) 14 (I) 8 (II) 8 (I) 11 (II) 12 (I) 7 (II) 7

5 Table 6 (cont.) Scores and radiographic results from included studies Score AOFAS HVA ( ) IMA ( ) DMAA ( ) Investigator Procedure Preop Postop Preop Postop Preop Postop Preop Postop Bauer et al. (26) Siclari et al. (33) Barragán- Hervella et al. (35) Magnan et al. (22) De Prado et al. (29) Roth et al. (23) Reverdin-Isham Bösch and NR NR arthroscopic lateral release Reverdin-Isham NR NR NR NR NR NR Magnan NR Reverdin-Isham NR NR NR NR NR NR Bösch (I) versus Kramer (II) NR NR (I) 30 (II) 29 (I) (II) (I) 12 (II) 12 (I) 7.67 (II) 7.19 Abbreviations: AOFAS, American Orthopedic Foot and Ankle Society (Ankle-Hindfoot scale); DMAA, distal metatarsal articular angle; HVA, hallux valgus angle; IMA, intermetatarsal angle; MOXFQ, Manchester-Oxford Foot Questionnaire; PECA, percutaneous chevron/akin ; NR, not reported; Postop, postoperative; Preop, preoperative. NR NR

6 Table 7 Complication of hallux valgus percutaneous surgery Investigator Patients (Feet)* HV Recurrence Lee M et al (44) Jowett CRJ et al (45) Biz C et al (46) Brogan K et al (47) 50 (50 25 PECA/25 Scarf and Akin) 87 (120) 12 (3 symptomat ic) Infection Skin Inflammatory Reaction Pulled Out K-Wires Nonunion Malunion Hallux Varus Complications CRPS Osteonecrosis Transfer Metatarsalgia (II) cases, screw removal because of screw prominence under the skin DVT Joint Stiffness cases, metatarsal screw removal because of screw prominence; 7 cases, proximal phalanx screw removal because of screw prominence; 3 cases, delayed asymptomatic radiologic union; 1 case undercorrection; 1 case overcorrection; 2 scar sensitivity; 1 case first metatarsal shortening (asymptomatic) 80 (80) cases, slight loss of normal range of MTP joint motion; 2 cases delayed wound healing; 1 case dysesthesia of the skin 81 (81 49 percutaneous/3 2 open) (I) 1 (II) (I) 4 cases, screw removal; 4 cases, paresthesia; (II) 1 case, screw removal; 1 case, paresthesia, 1 case persistent pain Fracture Other

7 Table 7 (Cont.) Complication of hallux valgus percutaneous surgery Complications Investigator Patients (Feet)* HV Recurrence Infection Skin Inflammatory Reaction Pulled Out K-Wires Nonunion Malunion Hallux Varus CRPS Osteonecrosis Transfer Metatarsalgia DVT Joint Stiffness Fractures Other Díaz Fernández et al (48) Kurashige T et al (49) Lam P et al (50) Lucas y Hernandez et al (51) Díaz Fernández et al (30) Cervi et al. (31) Rodríguez- Reyes et al. (32) Brogan et al. (3) Faour-Martín et al. (34) 46 (50) (superfici al) cases, elevation of the distal metatarsal bone; 15 (17) case, mild skin burn; 2 cases, numbness in great toe; 1 case, extension deformity of the proximal phalanx; 3 cases screw removal due to head prominence under skin 51 (60 27 Scarf and Akin/ 33 PECA) (I) (II) 6 cases, screw removal due to head prominence under skin 38 (45) cases, screw removal due to prominence under skin; 1 case, failure of fixation; 1 case, painful residual exostosis required surgery; 1 case, delayed union 42 (45) 3 (HVA>20º) case, loosening of osteosynthesis 213 (184) M cases DMAA P1 overcorrection 11 (20) NR NR NR NR NR NR NR NR NR NR NR NR NR NR 35 (45) case, screw backout 87 (115)

8 Table 7 (Cont.) Complication of hallux valgus percutaneous surgery Investigator Patients (Feet)* HV Recurrence Vernois et al. (19) Radwan et al. (25) De Lavigne et al. (27) Valles- Figueroa et al. (20) Luria et al. (21) Bauer et al. (28) Maffulli et al (24) Bauer et al. (26) Siclari et al. (33) Barragán- Hervella et al. (35) Magnan et al. (22) De Prado et al. (29) Roth et al. (23) Infection Skin Inflammatory Reaction Pulled Out K-Wires Nonunion Malunion Hallux Varus Complications CRPS Osteonecrosis Transfer Metatarsalgia 341 (408) (64-31 Magnan/33 Chevron) 0 (I) 2; (II) (I) 2; (II) cases, transient diminished sensation over medial aspect of great toe in Chevron group 6 (6) case, pain 40 (58) cases, pain 23 (23) cases, dorsal angulation of M1 head 82 (104) M1 e - 5P1 72 ( (I)1 (I) (II) 3 M1 (II), 5 cases, hardware Böch/36 Scarf) intolerance 168 (189) (59) (29) (118) (64) (88 Bösch/36 Kramer) 0 (I) 15; (II) (I) 10; (II) (I) 6; (II) 0 DVT Joint Stiffness Fracture Other (I) 1; (II) Abbreviations: CRPS, complex regional pain syndrome; DMAA, distal metatarsal articular angle; DVT, deep vein thrombosis; HV, hallux valgus; HVA, hallux valgus angle; K, Kirschner; M1, first metatarsal; NR, not reported; P1, proximal phalanx *Number of patients (number of feet).

9 Table 8 Complication of hallux valgus percutaneous surgery stratified by fixation type and technique Fixation Type None Technique Reverdin- Isham Patients (Feet)* HV Recurrence Infection Skin Inflamatory Reaction Pulled Out K- Wires Nonunion Malunion Hallux Varus CRPS Osteonecrosis Transfer Metatarsal gia DVT Joint Stiffness 647 (670) M1; 14P1 Fracture Other 16 cases loss of normal range of MTP joint, 6 cases DMAA overcorrection, 2 cases delayed wound healing, 1 case dysesthesia of skin K-Wire Bösch 283 (293) cases, hardware intolerance Magnan 153 (207) Screw Double Double Percutaneo us Chevron 88 (95) cases elevation of distal metatarsal bone 21 (23) cases hardware intolerance, 2 cases numbness in great toe, 1 case extension deformity of P1, 1 case pain, 1 case skin burn 645 (680) cases of hardware intolerance due to metatarsal skin prominence, 4 cases paresthesia, 4 cases delayed union, 2 cases scar sensitivity, 1 case M1 shortening, 1 case overcorrection, 1 case undercorrection, 1 case residual exostosis, 1 case failure of fixation Abbreviations: CRPS, complex regional pain syndrome; DMAA, distal metatarsal articular angle; DVT, deep vein thrombosis; HV, hallux valgus; K, Kirschner; NR, not reported; P1, proximal phalanx. *Number of patients (number of feet).

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11 Included Eligibility Screening Identificatio 96 records identified through Pubmed search 36 additional records identified through other sources 114 records after duplicates removed 114 records screened 50 full-text articles assessed for eligibility 26 studies included in qualitative synthesis 64 records excluded: - Systematic Reviews (5) - Theme reviews (14) - Open techniques (5) - MIS (10) - Cadaveric study (2) - Infantile population (3) - Other metatarsals/techniques (10) - Commentaries (5) - Technique description (3) - Case with < 10 patients (1) - Unavailable articles (5) - Biomechanical study (1) 24 full-text articles excluded: - MIS (14) - Economical study (1) - Anesthesiology study (1) - Technique description (3) - Expert Opinion (1) - Fixation method ive (2) - Older article of the same author (1) - Comparation between unilateral / bilateral (1) Figure 1 Flow diagram of studies excluded and included in the present study. MIS, minimally invasive surgery.