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11,931 result(s) for "Fractures, Bone - therapy"
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Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial
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.
Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial
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.
Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK
The most common fractures in children are torus (buckle) fractures of the wrist. Controversy exists over treatment, which ranges from splint immobilisation and discharge to cast immobilisation, follow-up, and repeat imaging. This study compared pain and function in affected children offered a soft bandage and immediate discharge with those receiving rigid immobilisation and follow-up as per treating centre protocol. In this randomised controlled equivalence trial we included 965 children (aged 4–15 years) with a distal radius torus fracture from 23 hospitals in the UK. Children were randomly allocated in a 1:1 ratio to the offer of bandage group or rigid immobilisation group using bespoke web-based randomisation software. Treating clinicians, participants, and their families could not be masked to treatment allocation. Exclusion criteria included multiple injuries, diagnosis at more than 36 h after injury, and inability to complete follow-up. The primary outcome was pain at 3-days post-randomisation measured using Wong-Baker FACES Pain Rating Scale. We performed a modified intention-to-treat and per protocol analysis. The trial was registered with ISRCTN registry, ISRCTN13955395. Between Jan 16, 2019, and July 13, 2020, 965 children were randomly allocated to a group, 489 to the offer of a bandage group and 476 to the rigid immobilisation group, 379 (39%) were girls and 586 (61%) were boys. Primary outcome data was collected for 908 (94%) of participants, all of whom were included in the modified intention-to-treat analysis. Pain was equivalent at 3 days with 3·21 points (SD 2·08) in the offer of bandage group versus 3·14 points (2·11) in the rigid immobilisation group. With reference to a prespecified equivalence margin of 1·0, the adjusted difference in the intention-to-treat population was –0·10 (95% CI –0·37 to 0·17) and–0·06 (95% CI –0·34 to 0·21) in the per-protocol population. This trial found equivalence in pain at 3 days in children with a torus fracture of the distal radius assigned to the offer of a bandage group or the rigid immobilisation group, with no between-group differences in pain or function during the 6 weeks of follow-up. UK National Institute for Health and Care Research.
Adequate union rates for the treatment of acute proximal fifth metatarsal fractures
Purpose To compare the bone healing, clinical, and return to daily activity outcomes after either surgical or conservative management of acute zone 1, 2, and 3 fifth metatarsal fractures. Methods A literature search was performed to identify studies published from the earliest record to January 2019 using EMBASE (Ovid), MEDLINE via PubMed, CINAHL, and Web of Science. All articles assessing clinical outcomes of acute proximal fifth metatarsal fractures were included. Bone healing and clinical outcomes were thereafter calculated using a simplified pooling method. Results Thirty-two articles comprising of a total of 1,239 fractures were included, of which one was a randomized controlled trial, seven were prospective studies, and 24 were retrospective studies. 627 zone 1 fractures demonstrated union rates of 93.2% following conservative treatment and 95.1% following surgical treatment. Conservatively managed zone 1 fractures were displaced 49.5% of the time, compared to a rate of 92.8% for the surgically treated cases. For Jones’ (zone 2) fractures, bone healing outcomes of conservative versus surgical treatment showed union rates of 77.4% versus 96.3%, refracture rates of 2.4% versus 2.1%, and mean time to union of 11.0 weeks versus 9.4 weeks, respectively. Only ten proximal diaphyseal (zone 3) fractures were reported, with a mean return to work of 8.2 weeks. Conclusion Acute zone 1 fractures are preferably treated conservatively as similar union rates were found after both conservative and surgical management. In contradistinction, acute zone 2 fractures demonstrate higher union rates and faster time to union when treated surgically. The outcomes of acute zone 3 fractures are rarely reported in the literature, so treatment recommendations remain unclear. Further research of proximal fifth metatarsal fractures is warranted to provide more definitive conclusions, but current findings can aid surgeons during the shared clinical decision making process. Level of evidence IV.
Reasons for declining to participate in a trial of online cognitive behavioural therapy following orthopaedic trauma: A mixed methods study
The timely enrollment of study participants is critical to the success of clinical trials. Understanding factors that contribute to patients’ decision to participate in trials involving online cognitive behavioural therapy for pain management should prove helpful to optimize the design of study protocols. Fracture patients from an orthopaedic clinic who declined to participate in the Cognitive behavioural therapy to Optimize Post-operative rEcovery (COPE) trial were asked to complete a Research Participation Questionnaire that asked them about their previous experiences with clinical research and mental health therapy and their reasons for declining to participate in the COPE trial. At the end of the questionnaire, a subset of participants was offered the opportunity to participate in a telephone interview to further discuss why they declined to participate in the COPE trial. Sixty-four patients who declined to participate in the COPE trial completed the questionnaire and twenty of these participants agreed to take part in a telephone interview (31%). Twenty-two participants (34%) had previous experience with clinical research and six participants (9%) had received cognitive behavioural therapy (CBT) in the past. Excessive time commitment (41%) was the most commonly selected reason for not participating in the COPE trial, followed by a disinclination to participate in clinical research (19%). Four themes emerged from the interviews with participants: 1) belief that they could overcome mental health challenges after their fracture without external help; 2) belief that CBT might be helpful for some fracture patients, but not for themselves; 3) preference for online or in-person CBT; and 4) concerns regarding time commitment. To maximize enrollment, trials exploring the role of psychotherapy in recovery from orthopedic trauma should optimize time commitment of psychotherapy. Providing information in the patient consent process regarding evidence for psychotherapy and recovery from orthopedic trauma may also prove helpful in promoting patient enrollment.
Acceptability and safety of 3D printed wrist-based orthoses compared to fiberglass casts for the treatment of non-surgical distal radius- and scaphoid fractures: A randomized feasibility trial
Non-invasiveness and comfort are crucial in the conservative management of distal radius and scaphoid fractures. While fiberglass casts are standard, three-dimensional (3D)-printed orthoses offer a promising alternative. To compare patient experiences, safety perceptions, and satisfaction between a 3D orthosis and fiberglass cast for distal radius or scaphoid fractures. Randomized feasibility trial. Nineteen adult patients were randomly assigned (3D orthosis group, n = 10; fiberglass cast group, n = 9) and followed until orthosis or cast removal at 6–8 weeks. X-rays at weeks 1 and 6 documented bone healing, with weekly hand therapy visits assessed orthosis satisfaction and function. The Patient-Rated orthosis Satisfaction Questionnaire (PRSEQ) measured satisfaction at weeks 2, 4, and removal. Descriptive statistics and non-parametric correlation tests were used for data analysis. The 3D orthosis group achieved significantly higher PRSEQ scores (mean difference [MD]= 15.7%, p = 0.005 to 0.01, r = −.581 to −.638) and lower perceived pain (MD=−1.0 to −2.2, p = 0.001 to 0.048, r = −0.45 to −0.75) compared to the cast group. By week 4, the 3D group reported less discomfort (MD=−2.2, p = 0.03, r = −0.5) and felt safer (MD=1.6, p = 0.043, r = −0.46). Routine activities were easier for the 3D group at weeks 2 and 6 (MD=−2.8 to −3.0, p = 0.033 to 0.034, r = −0.49). Satisfaction scores were higher in the 3D group (mean 8.4 vs. 5.6 points, p < 0.001 to 0.01, r = −0.57 to −0.82). Compliance was excellent in both groups. No significant differences were observed in radiological outcomes, finger sensibility, or edema. Bone healing occurred in both groups without fracture displacement; however, one cast patient required subsequent surgery for scaphoid non-union. Treatment with a 3D-printed orthosis appeared feasible and safe, with patients reporting higher satisfaction and better self-perceived hand function compared to a custom-made fiberglass cast, although further research is needed to confirm these findings. •Three-dimensional (3D)-printed orthoses seem feasible and safe for scaphoid and radius fractures.•Patients using 3D orthoses reported higher satisfaction and less pain than fiberglass casts.•Both groups demonstrated excellent compliance and comparable recovery outcomes.•Addressing 3D printing costs and production times is crucial for wider adoption.
Pilot randomized trial of pre-hospital advanced therapies for the control of hemorrhage (PATCH) using pelvic binders
Pelvic fractures represent a small percent of all skeletal injuries but are associated with significant morbidity and mortality secondary to hemodynamic instability from bleeding bone surfaces and disrupted pelvic vasculature. Stabilization of the pelvis prior to arrival at a treatment facility may mitigate the hemodynamic consequences of pelvic ring injuries and improve morbidity and mortality. Whether pelvic compression devices such as pelvic binders or sheets can be safely applied in the prehospital setting has not been well-studied. This study aims to evaluate the safety of applying a pelvic binder to at-risk patients in the field after scalable training and the feasibility of conducting a randomized trial evaluating this practice in the prehospital setting. A pilot study (prospective randomized trial design) was conducted in the pre-hospital environment in an urban area surrounding a level-one trauma center. Pre-hospital emergency medical (EMS) personnel were trained to identify patients at high-risk for pelvic fracture and properly apply a commercial pelvic binder. Adult patients with a high-energy mechanism, suspected pelvic fracture, and “Priority 1” criteria were prospectively identified by paramedics and randomized to pelvic binder placement or usual care. Medical records were reviewed for safety outcomes. Secondary outcomes were parameters of efficacy including interventions needed to control hemorrhage (such as angioembolization and surgical control of bleeding) and mortality. Forty-three patients were randomized to treatment (binder: N=20; nonbinder: N=23). No complications of binder placement were identified. Eight patients (40%) had binders placed correctly at the level of the greater trochanter. Two binders (10%) were placed too proximally and 10 (50%) binders were not visualized on x-ray. Two binder group patients and three nonbinder group patients required angioembolization. None required surgical control of pelvic bleeding. Two nonbinder group patients and one binder group patient were readmitted within 30 days and one nonbinder group patient died within 30 days. Identification of pelvic fractures in the field remains a challenge. However, a scalable training model for appropriate binder placement was successful without secondary injury to patients. The model for conducting prospective, randomized trials in the prehospital setting was successful.
Beyond the splint: efficacy and safety of kinesio taping for non-operative management of finger injuries
Background This prospective comparative study aimed to evaluate the efficacy of kinesio-taping (KT), buddy taping (BT), and conventional splinting in managing finger joint sprains and fractures across pediatric and adult populations, with a focus on functional recovery and patient-centered outcomes. Materials and methods A total of 175 patients were randomized into three treatment arms: KT (Group 1, n  = 62), BT (Group 2, n  = 52), and splinting (Group 3, n  = 61). Participants were stratified into pediatric (5–18 years) and adult (18–60 years) subgroups. Clinical outcomes—including range of motion (ROM), grip strength, and QuickDASH (QD) scores—were assessed by an independent orthopedic surgeon at 3-week and 3-month follow-ups. Results Baseline demographics (age, sex, injury laterality, and hand dominance) were comparable across groups ( p  > 0.05). Group 1 demonstrated statistically superior outcomes, with significantly greater ROM( p  < 0.001), lower QD scores ( p  < 0.001), and higher grip strength ( p  < 0.001) relative to splinting. Group 2 exhibited intermediate efficacy, outperforming splinting but remaining inferior to Group 1 ( p  < 0.001). Subgroup analyses confirmed consistent therapeutic advantages for KT in both pediatric and adult cohorts ( p  < 0.001). Discussion KT emerged as the most effective modality, offering enhanced patient comfort, superior pain management, and accelerated functional recovery in finger ligament injuries and fractures. Its capacity to facilitate early mobilization without compromising stability positions it as a preferable alternative to conventional splinting methods in diverse age groups.
Conservative treatment versus transverse pinning in fifth metacarpal neck fractures in active adults: a randomized controlled trial
Purpose Compare two simple ways for treating boxer’s fractures in active adults; conservative management by ulnar gutter slab and transverse pinning in fixation of fifth metacarpal's neck fracture regarding union, functional outcomes, and complications. Patients and methods Ninety patients with fifth metacarpals' neck fractures with palmar angulation (30–70°) were managed either conservatively by an ulnar gutter slab or surgically by transverse pinning technique from January 2020 to December 2021. Only 84 patients completed a 1-year follow-up. Patients with old, open, or mal-rotated fractures were excluded. The block-randomization method was used to create equal groups. Patients were evaluated clinically and radiologically every 2–3 weeks until union, then at 6 and 12 months. Functional assessment at the final visit was done using the quick DASH score, total active motion (TAM), and total Active Flexion (TAF). Results The mean radiological union time for the conservative group in this study was 7.76 weeks, while for the transverse pinning group, it was 7.38 weeks. There was no statistically significant difference between the two techniques regarding union rates and functional outcomes. All patients returned to their pre-injury jobs and level of activity. Conclusion Both conservative management in ulnar gutter slab and percutaneous transverse pinning are considered effective methods in the treatment of simple extra-articular fifth metacarpal neck fractures with angulation between 30 and 70 degrees (AO: 77 A3.1). The functional and radiological results using both methods were satisfactory and statistically comparable.
Can we avoid casting for suspected scaphoid fractures? A multicenter randomized controlled trial
Background In suspected scaphoid fractures with normal initial radiographs, the usual care is casting, but only 10% of patients have scaphoid fractures. To reduce overtreatment, we evaluated whether bandaging, instead of casting, resulted in noninferior functional outcomes. Patients and methods We included adults with suspected scaphoid fractures and normal initial radiographs at the emergency department in our multicenter randomized controlled trial. Patients were randomized to 3-day bandaging or 2-week casting. Questionnaires, physical examination, and radiographs were performed at 2 weeks and 1 year. Additional questionnaires were sent after inclusion, 6 weeks, and 3 months. Our primary outcome was the adjusted estimated difference between groups of the Quick Disabilities of the Arm, Shoulder, and Hand (QDASH) score at 3 months (natural logarithm of the margin of noninferiority = 2.0). Secondary outcomes included the QDASH score, Patient-Rated Hand/Wrist Evaluation Score, visual analog scale pain, wrist range of motion, patient satisfaction, and complications during follow-up. Results Of the 180 patients (91 bandaging and 89 casting), 16 had scaphoid fractures and there were no scaphoid nonunions. Functional outcome in the bandaging group was noninferior at 3 months compared with the casting group [adjusted estimated difference QDASH score 0.30 (95% CI 0.02–0.62)]. All other patient-reported function and pain scores were not significantly different between groups. Range of motion at 2 weeks was better in the bandaging group, and they were more satisfied with the treatment than the casting group. Conclusions Casting for suspected scaphoid fractures but normal initial radiographs can be avoided because bandaging seems to be an alternative treatment option when patients are reevaluated after 2 weeks. Level of evidence Level II. Trial registration Trial registered at the Trialregister on 2018-02-28 on www.trialregister.nl , NTR7164