Summary Background 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. Methods 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. Findings 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). Interpretation 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. Funding National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians’ Services Incorporated.
We conclude that the addition of L5 pedicle screws increases the stiffness and strength of the unit rod construct. Clinically, this should help to avoid complications associated with loss of fixation in this area.
Category: Ankle, Arthroscopy, Sports Introduction/Purpose: Syndesmotic disruption occurs in 10 to 13% of all ankle fractures. It is present in 15 cases per 100,000 of the general population. There has been debate on the best treatment for syndesmotic injuries. The typical surgical treatments include fixation with either screws or suture button devices. The purpose of this study is to compare clinical outcomes of syndesmotic injuries treated surgically with either screws or suture button devices. It was hypothesized that suture button fixation would provide equal clinical results with less need for hardware removal. Methods: This was a multi-center, randomized, prospective clinical trial comparing two surgical interventions for treatment of acute syndesmotic injury. At the time of surgical intervention, subjects were placed into either the screw fixation or the Suture-button device group by opening a randomized envelope in the operating room. Subjects with clinical signs or radiographic evidence of syndesmotic injury were asked to participate in this study. Inclusion criteria was ages 18 to 65 years old with confirmed syndesmotic instability. The primary outcomes of thestudy were VAS scores (activity, pain, satisfaction) and FFI scores (pain, disability, activity) which were collected at preoperative state, 6 weeks, and 12 months postoperatively. Results: Sixty-five subjects were enrolled in this study. Thirty-two subjects received Suture-button fixation (49%) and 33 received screw fixation (51%). VAS scores and FFI scores for subjects treated with the Suture-button device or screw fixation comparing preoperative, six-week, and 12-month scores all showed clinical improvement. There was no significant difference between the two treatment groups (p >0.05). Nine subjects (27%) in the syndesmotic screw fixation group experienced adverse events; four required repeat surgery for symptomatic syndesmotic screw removal, one for revision fixation, and four did not return to surgery despite hardware failure. One subject(3%) in the suture-button group required hardware removal. Conclusion: The short-term clinical outcomes suggest that both syndesmotic screws and suture-button devices are effective treatment options to address acute syndesmotic injuries. In the short-term (12-months), suture-button fixation resulted in significantly less adverse events compared to syndesmotic screw fixation group.
AIM:To compare functional outcomes and adverse events of surgically treated syndesmotic injuries with either screw(s) or suturebutton(s). It was hypothesized that suture-button fixation would provide equal clinical results with fewer adverse events. MATERIALS AND METHODS: Multi-center, randomized clinical study. Sixty-five subjects with confirmed acute syndesmotic injury requiring surgical intervention were enrolled. Subjects were randomized and treated with either suture-button or screw fixation. Foot and Function Index pain, disability, and activity scores, American Orthopaedic Foot and Ankle Society scores, and the Visual Analogue Scale for pain were reported up to 12-months. The adverse events were also collected. The forty subjects with complete data up to one year (n = 40; suture-button = 18 and screw = 22) were included in analysis. Single or multiple screws or suture-button implants were based on surgeon preference and patients' characteristics. RESULTS: There was statistically significant improvement in Foot and Function Index and American Orthopaedic Foot and Ankle Society scores with both techniques (p < 0.05). Visual Analog Scale scores improved significantly with the screw technique (p < 0.05) but not with the suture button technique. CONCLUSION: One-year clinical data suggests that acute syndesmotic injuries can be effectively treated with either technique. A possible benefit of suture button fixation may be a lower occurrence of adverse clinical events.
Results: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6-and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment.Conclusions: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional effort s to improve the outcomes of these challenging injuries are still needed.
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