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The Journal of Bone & Joint Surgery British Volume
Vol. 81-B, Issue 2 | Pages 312 - 316
1 Mar 1999
Wade RH New AMR Tselentakis G Kuiper JH Roberts A Richardson JB

Nomograms derived from mathematical analysis indicate that the level of malunion is the most important determinant of changes in the moment arm of the knee, the plane of the ankle and alterations in limb length. Testing in five patients undergoing reconstruction showed a mean error of postoperative limb length of 2.2 mm (. sd. 0.8 mm), knee moment arm of 4.7 mm (. sd. 3.3 mm) and ankle angle of 2.6° (. sd. 2.3°). These nomograms provide the information required when assessing whether a particular degree of angulation may be accepted


The Journal of Bone & Joint Surgery British Volume
Vol. 79-B, Issue 2 | Pages 273 - 279
1 Mar 1997
Marsh DR Shah S Elliott J Kurdy N

We have reviewed a series of 56 consecutive patients treated by the Ilizarov circular fixator for various combinations of nonunion, malunion and infection of fractures. We used segmental excision, distraction osteogenesis and gradual correction of the deformity as appropriate. Treatment was effective in eliminating 40 out of 46 nonunions and all 22 infections. There were two cases of refracture some months after removal of the frame, both of which healed securely in a second frame. Correction of malunion was good in the coronal plane but there was a tendency to anterior angulation, often occurring in the regenerate bone rather than at the original fracture site, after removal of the frame. This was associated with very slow maturation of regenerate bone in some patients, occurring largely, but not exclusively, in those who smoked heavily. Patients expressed high levels of satisfaction with the outcome, despite relatively modest improvements in pain and function, presumably because their longstanding and intractable nonunion had been treated. None the less, the degree of satisfaction correlated strongly with the degree of improvement in pain and function. We emphasise the importance of a multidisciplinary team in the assessment and support of patients undergoing long and demanding treatment. The Ilizarov method is valuable, but research is needed to overcome the problems of delayed maturation of the regenerate and slow or insecure healing of the docking site


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 5 | Pages 791 - 797
1 Sep 1998
Takahara M Sasaki I Kimura T Kato H Minami A Ogino T

Nine children sustained a second fracture of the distal humerus after union of an ipsilateral supracondylar fracture which had healed with cubitus varus. There were eight boys and one girl with a mean age of five years (1 to 8) at the time of the second fracture which occurred at a mean of 1.5 years after the first. In all patients, the second fracture was an epiphyseal injury of the distal humerus, either associated with a fracture of the lateral metaphysis below the site of the previous supracondylar fracture, or a fracture-separation of the entire distal humeral epiphysis. This suggests that the physis and epiphysis tend to be more subject to injury than the metaphysis of the distal humerus in children who have had a previous supracondylar fracture with varus malunion


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 5 | Pages 722 - 725
1 Sep 1996
van der Schoot DKE Den Outer AJ Bode PJ Obermann WR van Vugt AB

We re-examined clinically and radiologically 88 patients with a fracture of the lower leg at a mean follow-up of 15 years. Forty-three fractures (49%) had healed with malalignment of at least 5°. More arthritis was found in the knee and ankle adjacent to the fracture than in the comparable joints of the uninjured leg. Malaligned fractures showed significantly more degenerative changes.

Eighteen patients (20%) had symptoms in the fractured leg. There was a significant correlation between symptoms in the knee and arthritis but not between symptoms and ankle arthritis or malalignment.

We conclude that fractures of the lower leg should be managed so that the possibility of angular deformity and thereby late arthritis is minimised.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 449 - 454
15 Mar 2023
Zhang C Wang C Duan N Zhou D Ma T

Aims. The aim of this study was to assess the safety and clinical outcome of patients with a femoral shaft fracture and a previous complex post-traumatic femoral malunion who were treated with a clamshell osteotomy and fixation with an intramedullary nail (IMN). Methods. The study involved a retrospective analysis of 23 patients. All had a previous, operatively managed, femoral shaft fracture with malunion due to hardware failure. They were treated with a clamshell osteotomy between May 2015 and March 2020. The mean age was 42.6 years (26 to 62) and 15 (65.2%) were male. The mean follow-up was 2.3 years (1 to 5). Details from their medical records were analyzed. Clinical outcomes were assessed using the quality of correction of the deformity, functional recovery, the healing time of the fracture, and complications. Results. The mean length of time between the initial injury and surgery was 4.5 years (3 to 10). The mean operating time was 2.8 hours (2.05 to 4.4)), and the mean blood loss was 850 ml (650 to 1,020). Complications occurred in five patients (21.7%): two with wound necrosis, and three with deep vein thrombosis. The mean coronal deformity was significantly corrected from 17.78° (SD 4.62°) preoperatively to 1.35° (SD 1.72°) postoperatively (p < 0.001), and the mean sagittal deformity was significantly corrected from 20.65° (SD 5.88°) preoperatively to 1.61° (SD 1.95°; p < 0.001) postoperatively. The mean leg length discrepancy was significantly corrected from 3.57 cm (SD 1.27) preoperatively to 1.13 cm (SD 0.76) postoperatively (p < 0.001). All fractures healed at a mean of seven months (4 to 12) postoperatively. The mean Lower Extremity Functional Scale score improved significantly from 45.4 (SD 9.1) preoperatively to 66.2 (SD 5.5) postoperatively (p < 0.001). Partial cortical nonunion in the deformed segment occurred in eight patients (34.8%) and healed at a mean of 2.4 years (2 to 3) postoperatively. Conclusion. A clamshell osteotomy combined with IMN fixation in the treatment of patients with a femoral shaft fracture and a previous post-traumatic femoral malunion achieved excellent outcomes. Partial cortical nonunions in the deformed segment also healed satisfactorily. Cite this article: Bone Joint J 2023;105-B(4):449–454


Bone & Joint Open
Vol. 5, Issue 2 | Pages 117 - 122
9 Feb 2024
Chaturvedi A Russell H Farrugia M Roger M Putti A Jenkins PJ Feltbower S

Aims. Occult (clinical) injuries represent 15% of all scaphoid fractures, posing significant challenges to the clinician. MRI has been suggested as the gold standard for diagnosis, but remains expensive, time-consuming, and is in high demand. Conventional management with immobilization and serial radiography typically results in multiple follow-up attendances to clinic, radiation exposure, and delays return to work. Suboptimal management can result in significant disability and, frequently, litigation. Methods. We present a service evaluation report following the introduction of a quality-improvement themed, streamlined, clinical scaphoid pathway. Patients are offered a removable wrist splint with verbal and written instructions to remove it two weeks following injury, for self-assessment. The persistence of pain is the patient’s guide to ‘opt-in’ and to self-refer for a follow-up appointment with a senior emergency physician. On confirmation of ongoing signs of clinical scaphoid injury, an urgent outpatient ‘fast’-wrist protocol MRI scan is ordered, with instructions to maintain wrist immobilization. Patients with positive scan results are referred for specialist orthopaedic assessment via a virtual fracture clinic. Results. From February 2018 to January 2019, there were 442 patients diagnosed as clinical scaphoid fractures. 122 patients (28%) self-referred back to the emergency department at two weeks. Following clinical review, 53 patients were discharged; MRI was booked for 69 patients (16%). Overall, six patients (< 2% of total; 10% of those scanned) had positive scans for a scaphoid fracture. There were no known missed fractures, long-term non-unions or malunions resulting from this pathway. Costs were saved by avoiding face-to-face clinical review and MRI scanning. Conclusion. A patient-focused opt-in approach is safe and effective to managing the suspected occult (clinical) scaphoid fracture. Cite this article: Bone Jt Open 2024;5(2):117–122


Bone & Joint Open
Vol. 2, Issue 8 | Pages 646 - 654
16 Aug 2021
Martin JR Saunders PE Phillips M Mitchell SM Mckee MD Schemitsch EH Dehghan N

Aims. The aims of this network meta-analysis (NMA) were to examine nonunion rates and functional outcomes following various operative and nonoperative treatments for displaced mid-shaft clavicle fractures. Methods. Initial search strategy incorporated MEDLINE, PubMed, Embase, and the Cochrane Library for relevant randomized controlled trials (RCTs). Four treatment arms were created: nonoperative (NO); intramedullary nailing (IMN); reconstruction plating (RP); and compression/pre-contoured plating (CP). A Bayesian NMA was conducted to compare all treatment options for outcomes of nonunion, malunion, and function using the Disabilities of the Arm Shoulder and Hand (DASH) and Constant-Murley Shoulder Outcome scores. Results. In all, 19 RCTs consisting of 1,783 clavicle fractures were included in the NMA. All surgical options demonstrated a significantly lower odds ratio (OR) of nonunion in comparison to nonoperative management: CP versus NO (OR 0.08; 95% confidence interval (CI) 0.04 to 0.17); IMN versus NO (OR 0.07; 95% CI 0.02 to 0.19); RP versus NO (OR 0.07; 95% CI: 0.01 to 0.24). Compression plating was the only treatment to demonstrate significantly lower DASH scores relative to NO at six weeks (mean difference -10.97; 95% CI -20.69 to 1.47). Conclusion. Surgical fixation demonstrated a lower risk of nonunion compared to nonoperative management. Compression plating resulted in significantly less disability early after surgery compared to nonoperative management. These results demonstrate possible early improved functional outcomes with compression plating compared to nonoperative treatment. Surgical fixation of mid-shaft clavicle fractures with compression plating may result in quicker return to activity by rendering patients less disabled early after surgery. Cite this article: Bone Jt Open 2021;2(8):646–654


Bone & Joint Open
Vol. 5, Issue 3 | Pages 236 - 242
22 Mar 2024
Guryel E McEwan J Qureshi AA Robertson A Ahluwalia R

Aims. Ankle fractures are common injuries and the third most common fragility fracture. In all, 40% of ankle fractures in the frail are open and represent a complex clinical scenario, with morbidity and mortality rates similar to hip fracture patients. They have a higher risk of complications, such as wound infections, malunion, hospital-acquired infections, pressure sores, veno-thromboembolic events, and significant sarcopaenia from prolonged bed rest. Methods. A modified Delphi method was used and a group of experts with a vested interest in best practice were invited from the British Foot and Ankle Society (BOFAS), British Orthopaedic Association (BOA), Orthopaedic Trauma Society (OTS), British Association of Plastic & Reconstructive Surgeons (BAPRAS), British Geriatric Society (BGS), and the British Limb Reconstruction Society (BLRS). Results. In the first stage, there were 36 respondents to the survey, with over 70% stating their unit treats more than 20 such cases per year. There was a 50:50 split regarding if the timing of surgery should be within 36 hours, as per the hip fracture guidelines, or 72 hours, as per the open fracture guidelines. Overall, 75% would attempt primary wound closure and 25% would utilize a local flap. There was no orthopaedic agreement on fixation, and 75% would permit weightbearing immediately. In the second stage, performed at the BLRS meeting, experts discussed the survey results and agreed upon a consensus for the management of open elderly ankle fractures. Conclusion. A mutually agreed consensus from the expert panel was reached to enable the best practice for the management of patients with frailty with an open ankle fracture: 1) all units managing lower limb fragility fractures should do so through a cohorted multidisciplinary pathway. This pathway should follow the standards laid down in the "care of the older or frail orthopaedic trauma patient" British Orthopaedic Association Standards for Trauma and Orthopaedics (BOAST) guideline. These patients have low bone density, and we should recommend full falls and bone health assessment; 2) all open lower limb fragility fractures should be treated in a single stage within 24 hours of injury if possible; 3) all patients with fragility fractures of the lower limb should be considered for mobilisation on the day following surgery; 4) all patients with lower limb open fragility fractures should be considered for tissue sparing, with judicious debridement as a default; 5) all patients with open lower limb fragility fractures should be managed by a consultant plastic surgeon with primary closure wherever possible; and 6) the method of fixation must allow for immediate unrestricted weightbearing. Cite this article: Bone Jt Open 2024;5(3):236–242


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 5 | Pages 629 - 637
1 May 2008
Forward DP Davis TRC Sithole JS

Fractures of the distal radius occurring in young adults are treated increasingly by open surgical techniques, partly because of concern that failure to restore the alignment of the fracture accurately may cause symptomatic post-traumatic osteoarthritis in future years. We reviewed 106 adults who had sustained a fracture of the distal radius between 1960 and 1968 and who were below the age of 40 years at the time of injury. We carried out a clinical and radiological assessment at a mean follow-up of 38 years (33 to 42). No patient had required a salvage procedure. While there was radiological evidence of post-traumatic osteoarthritis after an intra-articular fracture in 68% of patients (27 of 40), the disabilities of the arm, shoulder and hand (DASH) scores were not different from population norms, and function, as assessed by the Patient Evaluation Measure, was impaired by less than 10%. Ordinal logistic regression analysis showed a significant relationship between narrowing of the joint space and extra-articular malunion (dorsal angulation and radial shortening) as well as intra-articular injury. Multivariate analysis revealed that grip strength had fallen to 89% of that of the uninjured side in the presence of dorsal malunion, but no measure of extra-articular malunion was significantly related to either the Patient Evaluation Measure or DASH scores. While anatomical reduction is the principal aim of treatment, imperfect reduction of these fractures may not result in symptomatic arthritis in the long term, and this should be considered when counselling patients on the risks and benefits of the many treatment options available


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 4 | Pages 689 - 692
1 Jul 1998
McCormack RG Leith JM

To determine the relative risk of complications in treating ankle fractures in patients with diabetes, we compared the results of the management of displaced malleolar fractures in 26 patients with those of a matched group of non-diabetic patients, using a case-controlled study. The groups were matched for patient age, fracture type and treating surgeon. The incidence of significant complications in diabetic patients was 42.3%. By contrast, there were no complications in the matched group of non-diabetic patients. Of 19 diabetic patients treated surgically, six developed major complications including one case of malunion, one of necrosis of the wound edge requiring a flap, and two of deep sepsis. Two patients required amputation and both died. Diabetic patients with displaced ankle fractures treated non-operatively had a high incidence of loss of reduction and malunion but these caused few symptoms. In these patients, non-operative management may be preferable in view of the high risks of major complications after surgery and the acceptance of malunion by the older patient with lower demands


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 1 | Pages 62 - 68
1 Jan 2001
Bhandari M Guyatt GH Swiontkowski MF Schemitsch EH

We have systematically reviewed the effect of alternative methods of stabilisation of open tibial fractures on the rates of reoperation, and the secondary outcomes of nonunion, deep and superficial infection, failure of the implant and malunion by the analysis of 799 citations on the subject, identified from computerised databases. Although 68 proved to be potentially eligible, only eight met all criteria for inclusion. Three investigators independently graded the quality of each study and extracted the relevant data. One study (n = 56 patients) suggested that the use of external fixators significantly decreased the requirement for reoperation when compared with fixation with plates. The use of unreamed nails, compared with external fixators (five studies, n = 396 patients), reduced the risk of reoperation, malunion and superficial infection. Comparison of reamed with unreamed nails showed a reduced risk of reoperation (two studies, n = 132) with the reamed technique. An indirect comparison between reamed nails and external fixators also showed a reduced risk of reoperation (two studies) when using nails. We have identified compelling evidence that unreamed nails reduced the incidence of reoperations, superficial infections and malunions, when compared with external fixators. The relative merits of reamed versus unreamed nails in the treatment of open tibial fractures remain uncertain


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 801 - 807
1 Jul 2023
Dietrich G Terrier A Favre M Elmers J Stockton L Soppelsa D Cherix S Vauclair F

Aims

Tobacco, in addition to being one of the greatest public health threats facing our world, is believed to have deleterious effects on bone metabolism and especially on bone healing. It has been described in the literature that patients who smoke are approximately twice as likely to develop a nonunion following a non-specific bone fracture. For clavicle fractures, this risk is unclear, as is the impact that such a complication might have on the initial management of these fractures.

Methods

A systematic review and meta-analysis were performed for conservatively treated displaced midshaft clavicle fractures. Embase, PubMed, and Cochrane Central Register of Controlled Trials (via Cochrane Library) were searched from inception to 12 May 2022, with supplementary searches in Open Grey, ClinicalTrials.gov, ProQuest Dissertations & Theses, and Google Scholar. The searches were performed without limits for publication date or languages.


Bone & Joint Open
Vol. 3, Issue 12 | Pages 953 - 959
23 Dec 2022
Raval P See A Singh HP

Aims

Distal third clavicle (DTC) fractures are increasing in incidence. Due to their instability and nonunion risk, they prove difficult to treat. Several different operative options for DTC fixation are reported but current evidence suggests variability in operative fixation. Given the lack of consensus, our objective was to determine the current epidemiological trends in DTC as well as their management within the UK.

Methods

A multicentre retrospective cohort collaborative study was conducted. All patients over the age of 18 with an isolated DTC fracture in 2019 were included. Demographic variables were recorded: age; sex; side of injury; mechanism of injury; modified Neer classification grading; operative technique; fracture union; complications; and subsequent procedures. Baseline characteristics were described for demographic variables. Categorical variables were expressed as frequencies and percentages.


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 72 - 81
1 Jan 2023
Stake IK Ræder BW Gregersen MG Molund M Wang J Madsen JE Husebye EE

Aims

The aim of this study was to compare the functional and radiological outcomes and the complication rate after nail and plate fixation of unstable fractures of the ankle in elderly patients.

Methods

In this multicentre study, 120 patients aged ≥ 60 years with an acute unstable AO/OTA type 44-B fracture of the ankle were randomized to fixation with either a nail or a plate and followed for 24 months after surgery. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score. Secondary outcome measures were the Manchester-Oxford Foot Questionnaire, the Olerud and Molander Ankle score, the EuroQol five-dimension questionnaire, a visual analogue score for pain, complications, the quality of reduction of the fracture, nonunion, and the development of osteoarthritis.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 401 - 411
1 Apr 2024
Carrothers A O'Leary R Hull P Chou D Alsousou J Queally J Bond SJ Costa ML

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Methods

Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 12 | Pages 1678 - 1684
1 Dec 2010
Mitchell SE Keating JF Robinson CM

The results of the treatment of 31 open femoral fractures (29 patients) with significant bone loss in a single trauma unit were reviewed. A protocol of early soft-tissue and bony debridement was followed by skeletal stabilisation using a locked intramedullary nail or a dynamic condylar plate for diaphyseal and metaphyseal fractures respectively. Soft-tissue closure was obtained within 48 hours then followed, if required, by elective bone grafting with or without exchange nailing. The mean time to union was 51 weeks (20 to 156). The time to union and functional outcome were largely dependent upon the location and extent of the bone loss. It was achieved more rapidly in fractures with wedge defects than in those with segmental bone loss. Fractures with metaphyseal defects healed more rapidly than those of comparable size in the diaphysis. Complications were more common in fractures with greater bone loss, and included stiffness of the knee, malunion and limb-length discrepancy. Based on our findings, we have produced an algorithm for the treatment of these injuries. We conclude that satisfactory results can be achieved in most femoral fractures with bone loss using initial debridement and skeletal stabilisation to maintain length, with further procedures as required


Bone & Joint Open
Vol. 3, Issue 7 | Pages 566 - 572
18 Jul 2022
Oliver WM Molyneux SG White TO Clement ND Duckworth AD

Aims

The primary aim was to estimate the cost-effectiveness of routine operative fixation for all patients with humeral shaft fractures. The secondary aim was to estimate the health economic implications of using a Radiographic Union Score for HUmeral fractures (RUSHU) of < 8 to facilitate selective fixation for patients at risk of nonunion.

Methods

From 2008 to 2017, 215 patients (mean age 57 yrs (17 to 18), 61% female (n = 130/215)) with a nonoperatively managed humeral diaphyseal fracture were retrospectively identified. Union was achieved in 77% (n = 165/215) after initial nonoperative management, with 23% (n = 50/215) uniting after surgery for nonunion. The EuroQol five-dimension three-level health index (EQ-5D-3L) was obtained via postal survey. Multiple regression was used to determine the independent influence of patient, injury, and management factors upon the EQ-5D-3L. An incremental cost-effectiveness ratio (ICER) of < £20,000 per quality-adjusted life-year (QALY) gained was considered cost-effective.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 11 | Pages 1499 - 1506
1 Nov 2008
Rammelt S Schneiders W Schikore H Holch M Heineck J Zwipp H

Fracture-dislocations of the tarsometatarsal (Lisfranc) joints are frequently overlooked or misdiagnosed at initial presentation. This is a comparative cohort study over a period of five years comparing primary open reduction and internal fixation in 22 patients (23 feet) with secondary corrective arthrodesis in 22 patients (22 feet) who presented with painful malunion at a mean of 22 months (1.5 to 45) after injury. In the first group primary treatment by open reduction and internal fixation for eight weeks with Kirschner-wires or screws was undertaken, in the second group treatment was by secondary corrective arthrodesis. There was one deep infection in the first group. In the delayed group there was one complete and one partial nonunion. In each group 20 patients were available for follow-up at a mean of 36 months (24 to 89) after operation. The mean American Orthopaedic Foot and Ankle Society midfoot score was 81.4 (62 to 100) after primary treatment and 71.8 (35 to 88) after corrective arthrodesis (t-test; p = 0.031). We conclude that primary treatment by open reduction and internal fixation of tarsometatarsal fracture-dislocations leads to improved functional results, earlier return to work and greater patient satisfaction than secondary corrective arthrodesis, which remains a useful salvage procedure providing significant relief of pain and improvement in function


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 9 | Pages 1206 - 1209
1 Sep 2007
Moonot P Ashwood N Hamlet M

Secure fixation of displaced proximal fractures of the humerus is a challenging problem. A total of 32 patients with acutely displaced three- or four-part proximal fractures of the humerus were treated by open reduction and internal fixation using the proximal humeral internal locking system (PHILOS) plate. There were 23 women and nine men with a mean age of 59.9 years (18 to 87). Data were collected prospectively and the outcomes were assessed using the Constant score. The mean follow-up was for 11 months (3 to 24). In 31 patients (97%) the fracture united clinically and radiologically at a mean of 10 weeks (8 to 24). The mean Constant score at final review was 66.5 (30 to 92). There was no significant difference in outcome when comparing patients aged more than 60 years (18 patients) with those aged less than 60 years (14 patients) (t-test, p = 0.8443). There was one case each of nonunion, malunion and a broken screw in the elderly population. This plate provides an alternative method of fixation for fractures of the proximal humerus. It provides a stable fixation in young patients with good-quality bone sufficient to permit early mobilisation. Failure of the screws to maintain fixation in the elderly remains a problem


Aims

Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures.

Methods

A structured search of MEDLINE, EMBASE, the online archives of Bone & Joint Publishing, and CENTRAL databases from inception until 28 July 2021 was performed. Randomized, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture nonunion, or chondral defects were excluded. Outcome data were assessed using the Risk of Bias 2 (ROB2) framework and synthesized in random-effect meta-analysis. The Preferred Reported Items for Systematic Review and Meta-Analyses guidance was followed throughout.