| 1. |
- Launonen, Antti P, et al.
(author)
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Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients (NITEP) : An open-label randomized trial
- 2023
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In: PLoS Medicine. - : Public Library of Science (PLoS). - 1549-1277 .- 1549-1676. ; 20:11
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Journal article (peer-reviewed)abstract
- BACKGROUND: Proximal humerus fractures (PHFs) are common fractures, especially in older female patients. These fractures are commonly treated surgically, but the consensus on the best treatment is still lacking.METHODS AND FINDINGS: The primary aim of this multicenter, randomized 3-arm superiority, open-label trial was to assess the results of nonoperative treatment and operative treatment either with locking plate (LP) or hemiarthroplasty (HA) of 3- and 4-part PHF with the primary outcome of Disabilities of the Arm, Shoulder, and Hand (DASH) at 2-year follow-up. Between February 2011 and December 2019, 160 patients 60 years and older with 3- and 4-part PHFs were randomly assigned in 1:1:1 fashion in block size of 10 to undergo nonoperative treatment (control) or operative intervention with LP or HA. In total, 54 patients were assigned to the nonoperative group, 52 to the LP group, and 54 to the HA group. Five patients assigned to the LP group were reassigned to the HA group perioperatively due to high comminution, and all of these patients had 4-part fractures. In the intention-to-treat analysis, there were 42 patients in the nonoperative group, 44 in the LP group, and 37 in the HA group. The outcome assessors were blinded to the study group. The mean DASH score at 2-year follow-up was 30.4 (standard error (SE) 3.25), 31.4 (SE 3.11), and 26.6 (SE 3.23) points for the nonoperative, LP, and HA groups, respectively. At 2 years, the between-group differences were 1.07 points (95% CI [-9.5,11.7]; p = 0.97) between nonoperative and LP, 3.78 points (95% CI [-7.0,14.6]; p = 0.69) between nonoperative and HA, and 4.84 points (95% CI [-5.7,15.4]; p = 0.53) between LP and HA. No significant differences in primary or secondary outcomes were seen in stratified age groups (60 to 70 years and 71 years and over). At 2 years, we found 30 complications (3/52, 5.8% in nonoperative; 22/49, 45% in LP; and 5/49, 10% in HA group, p = 0.0004) and 16 severe pain-related adverse events. There was a revision rate of 22% in the LP group. The limitation of the trial was that the recruitment period was longer than expected due to a high number of exclusions after the assessment of eligibility and a larger exclusion rate than anticipated toward the end of the trial. Therefore, the trial was ended prematurely.CONCLUSIONS: In this study, no benefit was observed between operative treatment with LP or HA and nonoperative treatment in displaced 3- and 4-part PHFs in patients aged 60 years and older. Further, we observed a high rate of complications related to operative treatments.TRIAL REGISTRATION: ClinicalTrials.gov NCT01246167.
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| 2. |
- Launonen, Antti P., et al.
(author)
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Operative versus non-operative treatment for 2-part proximal humerus fracture : A multicenter randomized controlled trial
- 2019
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In: PLoS Medicine. - : Public Library of Science (PLoS). - 1549-1277 .- 1549-1676. ; 16:7
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Journal article (peer-reviewed)abstract
- BackgroundAlthough 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.Methods and findingsThe 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.ConclusionsThis 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.
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| 3. |
- Sumrein, Bakir O, et al.
(author)
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Intraobserver and interobserver reliability of recategorized Neer classification in differentiating 2-part surgical neck fractures from multi-fragmented proximal humeral fractures in 116 patients.
- 2018
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In: Journal of shoulder and elbow surgery. - : Elsevier BV. - 1058-2746 .- 1532-6500. ; 27:10, s. 1756-1761
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Journal article (peer-reviewed)abstract
- BACKGROUND: Optimal fracture classification should be simple and reproducible and should guide treatment. For proximal humeral fractures, the Neer classification is commonly used. However, intraobserver and interobserver reliability of the Neer classification has been shown to be poor. In clinical practice, it is essential to differentiate 2-part surgical neck fractures from multi-fragmented fractures. Thus, the aim of this study was to evaluate whether surgeons can differentiate 2-part surgical neck fractures from multi-fragmented fractures using plain radiographs and/or computed tomography (CT).METHODS: Three experienced upper limb specialists and trauma surgeons (B.O.S., A.P.L., and V.L.) independently reviewed and classified blinded plain radiographs and CT scans of 116 patients as showing 2-part surgical neck fractures or multi-fragmented fractures. Each imaging modality was reviewed and classified separately by each surgeon, after which each surgeon reviewed both modalities at the same time. This process was repeated by all surgeons after 24 weeks. Intraobserver and interobserver analyses were conducted using Cohen and Fleiss κ values, respectively.RESULTS: The κ coefficient for interobserver reliability showed substantial correlation (0.61-0.73) and was as follows: 0.73 for radiographs alone, 0.61 for CT scans alone, and 0.72 for radiographs and CT scans viewed together. After 24 weeks, the process was repeated and intraobserver reliability was calculated.The κ coefficient for intraobserver reliability showed substantial correlation (0.62-0.75) and was as follows: 0.62 for radiographs alone, 0.64 for CT scans alone, and 0.75 for radiographs and CT scans viewed together.CONCLUSION: Clinicians were able to differentiate 2-part surgical neck fractures from multi-fragmented fractures based on plain radiographs reliably.
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