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- Launonen, AP, et al.
(författare)
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Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: The Nordic DeltaCon Trial protocol-non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial
- 2019
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 9:1, s. e024916-
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Tidskriftsartikel (refereegranskat)abstract
- The proximal humerus fracture (PHF) is one of the most common fractures in the elderly. The majority of PHFs are treated non-operatively, while 15%–33% of patients undergo surgical treatment. Recent randomised controlled trial (RCT) and meta-analyses have shown that there is no difference in outcome between non-operative treatment and locking plate or hemi-arthroplasty. During the past decade, reverse total shoulder arthroplasty (RTSA) has gained popularity in the treatment of PHF, although there is a lack of RCTs comparing RTSA to non-operative treatment.MethodsThis is a prospective, single-blinded, randomised, controlled, multicentre and multinational trial comparing RTSA with non-operative treatment in displaced proximal humeral fractures in patients 65–85 years. The primary outcome in this study is QuickDASH-score measured at 2 years. Secondary outcomes include visual analogue scale for pain, grip strength, Oxford shoulder score, Constant score and the number of reoperations and complications.The hypothesis of the trial is that operative treatment with RTSA produces better outcome after 2 and 5 years measured with QuickDASH.Ethics and disseminationIn this protocol, we describe the design, method and management of the Nordic DeltaCon trial. The ethical approval for the trial has been given by the Regional Committee for Medical and Health Research Ethics, Norway. There have been several examples in orthopaedics of innovations that result in failure after medium-term follow-ups . In order to prevent such failures and to increase our knowledge of RSTA, we feel a large-scale study of the effects of the surgery on the outcome that focuses on the complications and reoperations is warranted. After the trial 2-year follow-up, the results will be disseminated in a major orthopaedic publication.Trial registration numberNCT03531463; Pre-Results.
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| 2. |
- Launonen, Antti P., et al.
(författare)
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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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Ingår i: PLoS Medicine. - : Public Library of Science (PLoS). - 1549-1277 .- 1549-1676. ; 16:7
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Tidskriftsartikel (refereegranskat)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.
(författare)
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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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Ingår i: Journal of shoulder and elbow surgery. - : Elsevier BV. - 1058-2746 .- 1532-6500. ; 27:10, s. 1756-1761
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Tidskriftsartikel (refereegranskat)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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