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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
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
Analysis of the efficacy of Endobutton plate combined with high-strength suture Nice knot fixation in the treatment of distal clavicle fractures with coracoclavicular ligament injuries
by
Liu, Bin
,
Shi, Lei
,
Yu, Haiyang
in
Adult
,
Advances in minimally invasive orthopedic surgery
,
Bone healing
2024
Objective
To investigate the efficacy of Endobutton plate combined with high-strength suture Nice knot fixation in the treatment of distal clavicular fractures with coracoclavicular ligament injuries.
Methods
A retrospective analysis was performed on 43 patients who sustained distal clavicular fractures along with injuries to the coracoclavicular ligament. These patients were treated between January 2017 and December 2023. The fractures were classified according to the fixation method: high-strength Nice knot suture fixation (experimental group,
n
= 23) and acromioclavicular Kirschner wire fixation (control group,
n
= 20). The basic information of the two groups of patients, including age, gender, cause of injury, fracture classification, hospitalization duration, fracture healing time and complications, was collected and analyzed. The increase rate of coracoclavicular space on the affected side was collected and analyzed. The pain level of the affected shoulder was assessed using the visual analog scale (VAS). The shoulder joint function was assessed using the American Shoulder and Elbow Surgeons (ASES) scores and Constant-Murley scores before and after surgery.
Results
No significant differences were observed in the general demographic data, including age, gender, injury etiology, Craig classification, and hospitalization duration between the two groups (
p
> 0.05). Both groups were followed for a period ranging from 12 to 33 months, with an average follow-up of 20.53 ± 5.16 months. The bone healing time in the experimental group was significantly shorter than in the control group (12.82 ± 1.12 weeks vs. 17.25 ± 1.71 weeks,
p
< 0.05). At the final follow-up, The increase rate of coracoclavicular space was (9.25 ± 2.53) % in the experimental group and (8.10 ± 2.53) % in the control group, which was not significantly different (
p
> 0.05). Both groups demonstrated significant improvements in VAS scores, Constant-Murley scores, and ASES scores post-operatively compared to pre-operative values (
p
< 0.05
). One month after surgery, the Constant-Murley and ASES scores were significantly superior in the experimental group compared to the control group (
p
< 0.05). However, no statistical difference was observed three months post-surgery or during the final follow-up (
p
> 0.05). The control group reported one case of infection related to the Kirschner wire and one case of Kirschner wire displacement postoperatively. Conversely, no significant complications were reported in the experimental group.
Conclusion
In the management of distal clavicle fractures accompanied by coracoclavicular ligament injuries, particularly oblique fractures or those with butterfly-shaped fragments, the application of a high-strength Nice knot suture in conjunction with Endobutton plate fixation can effectively stabilize the fracture site. This approach not only mitigates complications associated with Kirschner wire fixation but also enhances fracture healing, leading to favorable postoperative outcomes.
Journal Article
Efficacy evaluation of Kirschner wire tension band combined with anatomical locking plate in the treatment of Mayo type II olecranon fractures
2025
Background
Kirschner wire tension band (KWTB) and anatomical plate fixation are the most often used procedures for treating Mayo type II olecranon Fractures, each has its technological advantages. However, there are often some associated complications with single use, the combination of Kirschner-wire tension band reduction and locking plate fixation in treating Mayo type II olecranon fractures has been seldom recorded. This research aims to compare the efficacy of KWTB alone and KWTB combined with anatomical locking plate (ALP) in the treatment of Mayo type II olecranon fractures.
Methods
Clinical data from 72 individuals who had surgery for Mayo type II olecranon fractures between January 2020 and December 2022 were evaluated retrospectively. Patients were randomized to either KWTB (
n
= 37, 19 males and 18 females; range 36 to 75 years; mean age 49.12 ± 9.51 years) or KWTB + ALP (
n
= 35, 16 males and 19 females; range 37 to 75 years; mean age 50.07 ± 9.45 years). Data including operative duration, intraoperative bleeding, incision length, hospital stay, postoperative complications, and the time to return to work, fracture union time, and follow-up time were documented. Their Disabilities of the Arm, Shoulder and Hand (DASH), Mayo elbow performance score and elbow range of motion (ROM) measures were utilized for functional assessments.
Results
The mean follow-up time was 28.03 ± 8.14 months, there were no statistical differences in general characteristics, intraoperative blood loss and length of incision between the two groups (
P
> 0. 05).The operative duration of KWTB + ALP group was greater than that of KWTB group (
P
< 0. 05). The average stay in the hospital was 8. 80 ± 2. 62 in the KWTB group and 6. 94 ± 3. 82 in the KWTB + ALP group (
P
= 0.0181). Patients come back to work in 9.6 ± 3.4 weeks in the KWTB group and 7.8 ± 2.7 weeks in the KWTB + ALP group (
P
= 0.0156). The rate of complications was considerably greater in the KWTB group (24.3% compared with 5.8%;
P
= 0.0283). The fracture union time was 15.36 ± 3.44 in the KWBT group and 12.28 ± 3.42 in the KWTB + ALP group (
P
= 0.003). The mean flexion-extension ROM values and pronation-supination ROM values showed no statistical difference between the two groups. The mean DASH score was 14.0 ± 2.8 in the KWTB group and 10.7 ± 3.2 in the KWTB + ALP group (
P
= 0.001). The average Mayo score was 84.0 ± 9.3 in the KWTB group and 88.3 ± 9.1 in the KWTB + ALP group (
P
= 0.0171). Mean Mayo score and mean DASH score were statistically different between the 02 groups.
Conclusion
Both operative procedures effectively treat Mayo type II olecranon fractures. Despite the fact that KWTB therapy is inexpensive and simple to administer, there is a high risk of complications associated with it. KWTB combined with ALP in the management of Mayo type II olecranon fracture, especially type IIB olecranon fracture has satisfactory medium and long-term outcome.
Journal Article
Comparison of intramedullary and extramedullary fixation of stable intertrochanteric fractures in the elderly: a prospective randomised controlled trial exploring hidden perioperative blood loss
2016
Background
Hip fracture is a severe and common injury that occurs predominantly in the elderly. Blood loss in the perioperative period is associated with a greater risk of dying in anaemic patients. The aim of the study was to explore the best way to treat stable intertrochanteric fractures, taking hidden blood loss into account.
Methods
This prospective, randomised blinded study included patients aged over 65 years with stable intertrochanteric fractures (Evans grades I and II). The patients were allocated to one of two groups treated via extramedullary or intramedullary fixation. Patient data were retrieved from electronic charts. Functional recovery was evaluated using the Functional Recovery Score of Zuckerman. Postoperative complications were also recorded. The formula of Nadler and Gross was used to calculate blood loss.
Results
There were 92 patients in the extramedullary and 106 in the intramedullary group. Age, sex, the cause of injury, the type of fracture, the observed blood loss, functional recovery, time to union, complications, and American Society of Anesthesiologists classification did not differ significantly between the two groups (all
p
-values > 0.05). The frequencies of lung infection, electrolyte imbalance, and hypoproteinemia differed between groups (all
p
-values < 0.05). Total and hidden blood loss were higher in the intramedullary group (
p
= 0.001).
Conclusion
Extramedullary (compared with intramedullary) fixation of stable intertrochanteric fractures significantly reduces perioperative blood loss but affords similar functional outcomes and times to union. In view of the morbidity and complications associated with acute anaemia and transfusions, extramedullary fixation may be the optimal choice for treatment of stable fractures, being associated with reduced blood loss.
Trial registration
The study was retrospectively registered at the Chinese Clinical Trial Registry, number:
ChiCTR-INQ-16009754
, trial registration date: 6th Nov. 2016.
Journal Article
Hemiarthroplasty versus internal fixation in super-aged patients with undisplaced femoral neck fractures: a 5-year follow-up of randomized controlled trial
2017
IntroductionThere were higher rates of revision, complication, non-union, delayed union, and poorer functional outcomes reported in super-aged patients of undisplaced femoral neck fractures treated with internal fixation. Therefore, we designed this randomized comparative study aiming to compare the effectiveness and long-term follow-up results of hemiarthroplasty (HA) with that of multiple cannulated screws (MCS).Materials and methodsEligible participants were randomly assigned into two groups for different methods of operation (hemiarthroplasty group and internal fixation group). The related indexes and data of two groups were collected for comparative analysis during the average follow-up period of 38.68 ± 28.24 months.ResultsThere were only two patients performed reoperation in HA group, and the reoperation rate of HA group (5.41%, 2/37) was significantly lower than that of IF group (21.4%, 9/41) (P value = 0.000). The comparison of survival curves for reoperation showed significant differences between two groups (P value = 0.031).The results of Cox proportional hazards model suggested that only operation method significantly affected the occurrence of reoperation (P value = 0.049). The results of survival analysis showed that there was no significant difference in survival time between two groups (P value = 0.682). And in the Cox proportional hazards model, only age significantly affected the occurrence of death (P value = 0.000). The average Harris scores of two groups were all above 75 points, and there was no significant difference in Harris scores between the two groups (P value greater than 0.05). But in the early term follow-up, the excellent and good rate of hip joint function in HA group was significantly higher than that in IF group (P value less than 0.05).ConclusionsHemiarthroplasty with less postoperative complications, low reoperation rate and better function recovery in early stage provide a good choice for the treatment of super-aged patients with nondisplaced femoral neck fracture.
Journal Article
Helical plating yields better outcomes than intramedullary nailing or long straight lateral plating for humeral shaft fractures extending to the proximal humerus
2025
Background
This study was performed to compare the operative clinical outcomes of helical plating, intramedullary nailing (IMN), and long straight lateral plating in the treatment of humeral shaft fractures extending into the proximal humerus, as well as to identify the optimal fixation strategy for managing such injuries.
Methods
In total, 81 patients with humeral shaft fractures extending into the proximal humerus were divided into three groups based on treatment strategy: helical plating (Group A,
n
= 16), IMN (Group B,
n
= 12), and long straight lateral plating (Group C,
n
= 53). Preoperative demographic data and imaging were collected from the medical records. Operative time, blood transfusion, bone reduction quality, bone healing rate, and incidence of complications were recorded. Clinical evaluation included the Constant–Murley score for shoulder function, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for upper limb function, the visual analogue scale (VAS) for pain, and assessments of shoulder stiffness or instability and patient satisfaction.
Results
Compared with Groups A and C, patients in Group B had a longer operative time and lower blood transfusion requirements. More than 80% of patients in each group achieved bone reduction quality rated as “better than good.” There were no significant differences among the three groups in operative time, blood transfusion, or shaft angulation. Bone healing rates were 100%, 91.7%, and 94.3% in Groups A, B, and C, respectively. Mean shoulder flexion was 155.0°, 130.0°, and 150.0°, respectively. Functional outcomes, including the Constant–Murley score, DASH score, VAS score, and patient satisfaction, were significantly better in Group A than in Groups B and C. No complications occurred in Group A. One patient in Group B developed nonunion. In Group C, complications were observed in five patients (9.4%).
Conclusion
In the treatment of humeral shaft fractures extending into the proximal humerus, helical plating was associated with a higher bone union rate, better functional outcomes, and a lower postoperative complication rate compared with IMN or long straight lateral locking plates. Outcomes after nailing and long straight lateral plating were similar.
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