Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study

Background Proximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al . demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, t...

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Vydáno v:BMC musculoskeletal disorders Ročník 13; číslo 1; s. 167
Hlavní autoři: Launonen, Antti P, Lepola, Vesa, Flinkkilä, Tapio, Strandberg, Niko, Ojanperä, Johanna, Rissanen, Pekka, Malmivaara, Antti, Mattila, Ville M, Elo, Petra, Viljakka, Timo, Laitinen, Minna
Médium: Journal Article
Jazyk:angličtina
Vydáno: London BioMed Central 07.09.2012
BioMed Central Ltd
Springer Nature B.V
BMC
Témata:
Analysis
Bone Plates
Care and treatment
Classification
Clinical trials
Conservative
Epidemiology
Epoca
Follow-Up Studies
Fracture
Fractures
Hand surgery
Health care
Hospitals
Humans
Humerus
Hypotheses
Implants, Artificial
Internal fixation in fractures
Internal Fixators
Internal Medicine
Joint Prosthesis
Locking plate
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Musculoskeletal diseases
Operative
Orthopedics
Pain
Patient satisfaction
Philos
Prospective Studies
Prostheses
Prosthesis
Proximal
Quality of life
RCT
Rehabilitation
Rheumatology
Shoulder Fractures - diagnosis
Shoulder Fractures - epidemiology
Shoulder Fractures - surgery
Sports Medicine
Study Protocol
Surgery
Treatment Outcome
Finland
Proximal
Locking plate
Philos
Epoca
RCT
Prosthesis
Conservative
Fracture
Operative
Humerus
ISSN:1471-2474, 1471-2474
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Shrnutí:Background Proximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al . demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials. Methods/Design The study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score and the secondary outcome measures will be the EuroQol-5D (EQ-5D) value, OSS, Constant-Murley Score, VAS, and 15D. Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period. Discussion This publication presents a prospective, randomized, national multi-center trial. It gives details of patient flow, randomization, aftercare and also ways of analysis of the material and ways to present and publish the results. Trial registration ClinicalTrials.gov identifier: NCT01246167
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ISSN:1471-2474
1471-2474
DOI:10.1186/1471-2474-13-167