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Neither operative nor nonoperative approach is superior for treating displaced midshaft clavicle fractures: a partially blinded randomized controlled clinical trial

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@article{09fbf8ea519d4051bc8ebd5040c5ce0d,
title = "Neither operative nor nonoperative approach is superior for treating displaced midshaft clavicle fractures: a partially blinded randomized controlled clinical trial",
abstract = "AIMS: To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups. METHODS: Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes. RESULTS: At 12 months, 87.5% of patients (n = 105) were available for analysis. The two groups were well balanced based on demographic and fracture-related characteristics. At six weeks of follow-up a significant difference in DASH score (p < 0.001) was found in favour of operative treatment. The functionality at 12 months of follow-up based on CS and DASH was excellent in both groups (CS > 90 points and DASH < 10 points) with no significant difference (p = 0.277 for DASH and p = 0.184 for CS) between the two groups. The risk of symptomatic nonunion was significantly higher in the nonoperative group (p = 0.014), with a relative risk of 9.47 (95% confidence interval (CI) 1.26 to 71.53) in this group compared to the operative group. The number-needed-to-treat to avoid one symptomatic nonunion was 6.2. Initial treatment and age were factors significantly associated with nonunion in a logistic analysis. There were 26% in both groups (n = 14 in operative group and n = 15 in nonoperative group) who required secondary surgery, with most indications in the nonoperative group mandatory due to nonunion compared to most relative indications in the operative group requiring intervention due to implant irritation. CONCLUSION: Superiority was not identified with either an all-operative or all-nonoperative approach. The functionality at short term (within six weeks) seems igreater following operative treatment but was not found at one year. The risk of nonunion is significantly higher with nonoperative treatment. However, an all-operative approach to lower the nonunion risk may result in unnecessary surgery and is not recommended. Cite this article: Bone Joint J 2021;103-B(4):762-768.",
keywords = "Clavicle fractures, Nonoperative treatment, Nonunion, Operative treatment",
author = "Ilija Ban and Kristensen, {Morten Tange} and Barfod, {Kristoffer Weisskirchner} and Jacob Eschen and Thomas Kallemose and Anders Troelsen",
note = "Copyright: This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine",
year = "2021",
month = apr,
day = "1",
doi = "10.1302/0301-620X.103B4.BJJ-2020-1636.R1",
language = "English",
volume = "103-B",
pages = "762--768",
journal = "Bone and Joint Journal",
issn = "2049-4394",
publisher = "British Editorial Society of Bone and Joint Surgery",
number = "4",

}

RIS

TY - JOUR

T1 - Neither operative nor nonoperative approach is superior for treating displaced midshaft clavicle fractures

T2 - a partially blinded randomized controlled clinical trial

AU - Ban, Ilija

AU - Kristensen, Morten Tange

AU - Barfod, Kristoffer Weisskirchner

AU - Eschen, Jacob

AU - Kallemose, Thomas

AU - Troelsen, Anders

N1 - Copyright: This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine

PY - 2021/4/1

Y1 - 2021/4/1

N2 - AIMS: To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups. METHODS: Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes. RESULTS: At 12 months, 87.5% of patients (n = 105) were available for analysis. The two groups were well balanced based on demographic and fracture-related characteristics. At six weeks of follow-up a significant difference in DASH score (p < 0.001) was found in favour of operative treatment. The functionality at 12 months of follow-up based on CS and DASH was excellent in both groups (CS > 90 points and DASH < 10 points) with no significant difference (p = 0.277 for DASH and p = 0.184 for CS) between the two groups. The risk of symptomatic nonunion was significantly higher in the nonoperative group (p = 0.014), with a relative risk of 9.47 (95% confidence interval (CI) 1.26 to 71.53) in this group compared to the operative group. The number-needed-to-treat to avoid one symptomatic nonunion was 6.2. Initial treatment and age were factors significantly associated with nonunion in a logistic analysis. There were 26% in both groups (n = 14 in operative group and n = 15 in nonoperative group) who required secondary surgery, with most indications in the nonoperative group mandatory due to nonunion compared to most relative indications in the operative group requiring intervention due to implant irritation. CONCLUSION: Superiority was not identified with either an all-operative or all-nonoperative approach. The functionality at short term (within six weeks) seems igreater following operative treatment but was not found at one year. The risk of nonunion is significantly higher with nonoperative treatment. However, an all-operative approach to lower the nonunion risk may result in unnecessary surgery and is not recommended. Cite this article: Bone Joint J 2021;103-B(4):762-768.

AB - AIMS: To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups. METHODS: Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes. RESULTS: At 12 months, 87.5% of patients (n = 105) were available for analysis. The two groups were well balanced based on demographic and fracture-related characteristics. At six weeks of follow-up a significant difference in DASH score (p < 0.001) was found in favour of operative treatment. The functionality at 12 months of follow-up based on CS and DASH was excellent in both groups (CS > 90 points and DASH < 10 points) with no significant difference (p = 0.277 for DASH and p = 0.184 for CS) between the two groups. The risk of symptomatic nonunion was significantly higher in the nonoperative group (p = 0.014), with a relative risk of 9.47 (95% confidence interval (CI) 1.26 to 71.53) in this group compared to the operative group. The number-needed-to-treat to avoid one symptomatic nonunion was 6.2. Initial treatment and age were factors significantly associated with nonunion in a logistic analysis. There were 26% in both groups (n = 14 in operative group and n = 15 in nonoperative group) who required secondary surgery, with most indications in the nonoperative group mandatory due to nonunion compared to most relative indications in the operative group requiring intervention due to implant irritation. CONCLUSION: Superiority was not identified with either an all-operative or all-nonoperative approach. The functionality at short term (within six weeks) seems igreater following operative treatment but was not found at one year. The risk of nonunion is significantly higher with nonoperative treatment. However, an all-operative approach to lower the nonunion risk may result in unnecessary surgery and is not recommended. Cite this article: Bone Joint J 2021;103-B(4):762-768.

KW - Clavicle fractures

KW - Nonoperative treatment

KW - Nonunion

KW - Operative treatment

UR - http://www.scopus.com/inward/record.url?scp=85103744213&partnerID=8YFLogxK

U2 - 10.1302/0301-620X.103B4.BJJ-2020-1636.R1

DO - 10.1302/0301-620X.103B4.BJJ-2020-1636.R1

M3 - Journal article

C2 - 33789482

VL - 103-B

SP - 762

EP - 768

JO - Bone and Joint Journal

JF - Bone and Joint Journal

SN - 2049-4394

IS - 4

ER -

ID: 64651599