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"Fracture Fixation, Internal"
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Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial
2017
Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes.
For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813.
Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63–1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06–3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0·41) and sepsis (seven [1%] vs six [1%]; p=0·79).
In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws.
National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians' Services Incorporated.
Journal Article
Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial
by
Jonsson, Kenneth B.
,
Wolf, Olof
,
Märtson, Aare
in
Aged
,
Aged, 80 and over
,
Biology and Life Sciences
2019
Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures.
The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded.
This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial.
ClinicalTrials.gov NCT01246167.
Journal Article
Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial
by
González-Osuna, Aránzazu
,
Patel, Ameen
,
Sharma, Achal
in
Activities of Daily Living
,
Aged
,
Aged, 80 and over
2020
Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications.
HIP ATTACK was an international, randomised, controlled trial done at 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were aged 45 years or older were eligible. Research personnel randomly assigned patients (1:1) through a central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. The coprimary outcomes were mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Patients, health-care providers, and study staff were aware of treatment assignment, but outcome adjudicators were masked to treatment allocation. Patients were analysed according to the intention-to-treat principle. This study is registered at ClinicalTrials.gov (NCT02027896).
Between March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4–9) in the accelerated-surgery group and 24 h (10–42) in the standard-care group (p<0·0001). 140 (9%) patients assigned to accelerated surgery and 154 (10%) assigned to standard care died, with a hazard ratio (HR) of 0·91 (95% CI 0·72 to 1·14) and absolute risk reduction (ARR) of 1% (−1 to 3; p=0·40). Major complications occurred in 321 (22%) patients assigned to accelerated surgery and 331 (22%) assigned to standard care, with an HR of 0·97 (0·83 to 1·13) and an ARR of 1% (−2 to 4; p=0·71).
Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care.
Canadian Institutes of Health Research.
Journal Article
Femoral neck locking plate versus multiple cannulated screws for femoral neck fractures in young adults: a randomized controlled trial
by
Khalefa, Abdelrahman Hafez
,
Ahmed, Khalaf Fathy Elsayed
,
Ahmed, Islam Mohammed
in
Adult
,
Antibiotics
,
Avascular necrosis
2025
Background
Managing femoral neck fractures (FNFs) in young adults remains a significant clinical dilemma. No single internal fixation method has demonstrated clear superiority. The aim of this study was to compare the clinical and radiographic outcomes of FNFs in young adults treated with femoral neck locking plate (FNLP) or conventional partially-threaded 6.5 mm multiple cannulated cancellous screws (MCCS).
Methods
A randomized controlled clinical trial (RCT) study was conducted on 74 patients to assess FNLP and MCCS in management of FNFs in young adults in Sohag university hospital between October 2022 and October 2024. The outcomes included Harris Hip Score (HHS), weight-bearing timelines, radiographic union times, and complication rates.
Results
FNLP demonstrated superior functional outcomes with significantly higher HHS scores compared to MCCS. Patients treated with FNLP achieved earlier partial and full weight-bearing (
p
<.001) and faster radiographic union times (
p
=.012), indicating better biomechanical stability. MCCS had a significantly shorter operative time at (49.3 ± 3.5 min) compared to the FNLP group at (62.3 ± 9.9 min), (
p
=.042). Complication rates, including femoral neck shortening, avascular necrosis, and infection, were comparable between the two groups.
Conclusion
FNLP is a more effective fixation method for young adults with FNFs, offering faster functional recovery and improved radiographic outcomes. MCCS demonstrated significant shorter operative time which is a potential advantage especially in resources-constrained settings. Complication rates were similar between FNLP and MCCS, making MCCS a viable option in selected cases based on fracture severity, surgical expertise, and resources availability.
Level of evidence
Level II therapeutic: prospective randomized controlled clinical trial.
Trial registration
The trial was retrospectively registered at 27 November, 2023 at
www.clinicaltrials.gov
(Trial Registration Number: NCT06162637).
Journal Article
Subcutaneous vs. transcutaneous K-wires for proximal phalanx fractures: a prospective randomized trial on infection rates
by
Held, Manuel
,
Müller, Amelie
,
Daigeler, Adrien
in
Adult
,
Bone Wires - adverse effects
,
Female
2025
In this randomized prospective trial, we compared K-wire osteosynthesis techniques for fractures of the proximal phalanx. Between April 2021 and February 2024, 28 patients treated at the BG Trauma Center Tuebingen were divided into two groups. Both groups underwent osteosynthesis with two K-wires: in Group A, the wire ends were left transcutaneous, while in Group B, they were buried subcutaneously. Follow-up revealed a significantly lower infection rate with subcutaneous wires (5.89%) compared to transcutaneous wires (45.46%). The postoperative infection occurred within the first 6 weeks after surgery. Two patients had to undergo surgical revision changing or removing the K-wires unexpectedly. Additionally, the total active range of motion of the PIP joint in Group A was 21.85° less than in Group B. Patients also expressed a preference for subcutaneous placement of wire ends. These findings strongly support burying K-wire ends after osteosynthesis of proximal phalanx fractures.
Journal Article
Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial
2020
Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less.
This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1–2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing.
Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2–14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference −2·1 [95% CI −5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group).
Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite.
National Institute for Health Research Health Technology Assessment Programme.
Journal Article
Supra-pectineal quadrilateral buttress plating versus infra-pectineal plating in the management of quadrilateral plate fractures: A randomized controlled trial
2025
Purpose
Management of quadrilateral plate fractures is technically demanding and requires specific fixation techniques. Infra-pectineal plating is the gold standard method of fixation. However, we recorded a high incidence of medial wall displacement and reoperations. Therefore, the aim of our study was to identify whether supra-pectineal quadrilateral buttress plating provides much more rigid fixation with a better functional and radiological outcome or not.
Patients and Methods
The authors conducted this prospective, randomized control, single-blinded study at a level 1 single trauma centre. Between March 2022 and June 2023, 34 patients with quadrilateral plate fractures had anterior fixation, either via the anatomical QLP (17 cases) or infra-pectineal plating (17 cases) (Groups A and B, respectively). The radiological and clinical outcomes, as well as residual medial wall displacement, were the primary outcomes.
Results
The mean follow-up was 14.47 months in group A and 15.24 months in group B. In group A, the mean operative time (
p
= 0.02) was shorter, and the mean blood loss (
p
< 0.001) was significantly lower. However last follow-up showed no statistically significant differences as regards residual medial wall displacement (
p
= 1.0), final radiological (
p
= 0.86), and clinical outcomes (
p
= 1.0).
Conclusion
Authors concluded that the anatomical QLP made it easier to reduce and fix acetabular fractures with a displaced medial wall. This was done by using multidirectional screws in the posterior column through its infra-pectineal extension and a strong screw purchase aimed at the posterior column through its supra-pectineal part
.
The two groups were similar in terms of final radiological and clinical outcomes, as well as residual medial wall displacement rates. However, the QLP had less morbidity than the classic infra-pectineal plating (shorter operation time and less blood loss).
Journal Article
Effect of melatonin on incidence of delirium among patients with hip fracture: a multicentre, double-blind randomized controlled trial
by
de Jonghe, Annemarieke
,
Levi, Marcel
,
Kloen, Peter
in
Aged
,
Aged, 80 and over
,
Arthroplasty, Replacement, Hip - adverse effects
2014
Disturbance of the sleep–wake cycle is a characteristic of delirium. In addition, changes in melatonin rhythm influence the circadian rhythm and are associated with delirium. We compared the effect of melatonin and placebo on the incidence and duration of delirium.
We performed this multicentre, double-blind, randomized controlled trial between November 2008 and May 2012 in 1 academic and 2 nonacademic hospitals. Patients aged 65 years or older who were scheduled for acute hip surgery were eligible for inclusion. Patients received melatonin 3 mg or placebo in the evening for 5 consecutive days, starting within 24 hours after admission. The primary outcome was incidence of delirium within 8 days of admission. We also monitored the duration of delirium.
A total of 452 patients were randomly assigned to the 2 study groups. We subsequently excluded 74 patients for whom the primary end point could not be measured or who had delirium before the second day of the study. After these postrandomization exclusions, data for 378 patients were included in the main analysis. The overall mean age was 84 years, 238 (63.0%) of the patients lived at home before admission, and 210 (55.6%) had cognitive impairment. We observed no effect of melatonin on the incidence of delirium: 55/186 (29.6%) in the melatonin group v. 49/192 (25.5%) in the placebo group; difference 4.1 (95% confidence interval −0.05 to 13.1) percentage points. There were no between-group differences in mortality or in cognitive or functional outcomes at 3-month follow-up.
In this older population with hip fracture, treatment with melatonin did not reduce the incidence of delirium. Trial registration: Netherlands Trial Registry, NTR1576: MAPLE (Melatonin Against PLacebo in Elderly patients) study; www.trialregister.nl/trialreg/admin/rctview.asp?TC=1576
Journal Article
Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial
2014
Objective To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures.Design Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial).Setting 22 tertiary referral hospitals, United Kingdom.Participants 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment.Main outcome measures The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat.Results 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference −7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8).Conclusions Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541.
Journal Article