Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic

NCT ID: NCT04623346

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-11

Study Completion Date

2020-12-01

Brief Summary

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This is a one centered retrospective study. Tendency for surgical interventions in the pre-pandemic period was reduced to protect surgical team and patients. The investigators aimed to find out the answer to the following question: will conservative treatment be the shining star in the post pandemic period?

Detailed Description

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The researchers compared the treatments performed for fractures during the Covid 19 pandemic period with the treatments performed in the prepandemic period. For this purpose, they tried to measure the effectiveness of the treatments according to clinical scoring by forming 2 groups.

Conditions

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Ankle Fractures Proximal Humeral Fracture Wrist Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Weber B-type Ankle fractures in prepandemic period

Patients with AO Weber B-type ankle fracture in prepandemic period

No interventions assigned to this group

Weber B-type Ankle fractures in pandemic period

Patients with AO Weber B-type ankle fracture in pandemic period

Observation for study group

Intervention Type PROCEDURE

Patients with Weber B-type Ankle fractures, extraarticular wrist fractures and proximal humerus fractures were followed with conservative manner( cast or sling)

Wrist fractures in prepandemic period

Patients with extraarticular distal radius fracture in prepandemic period

No interventions assigned to this group

Wrist fractures in pandemic period

Patients with extraarticular distal radius fracture in pandemic period

Observation for study group

Intervention Type PROCEDURE

Patients with Weber B-type Ankle fractures, extraarticular wrist fractures and proximal humerus fractures were followed with conservative manner( cast or sling)

Proximal humerus fractures in prepandemic period

Patients with 2-part,3-part and 4-part fractures in prepandemic period

No interventions assigned to this group

Proximal humerus fractures in pandemic period

Patients with 2-part,3-part and 4-part fractures in pandemic period

Observation for study group

Intervention Type PROCEDURE

Patients with Weber B-type Ankle fractures, extraarticular wrist fractures and proximal humerus fractures were followed with conservative manner( cast or sling)

Interventions

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Observation for study group

Patients with Weber B-type Ankle fractures, extraarticular wrist fractures and proximal humerus fractures were followed with conservative manner( cast or sling)

Intervention Type PROCEDURE

Other Intervention Names

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Surgery for control group

Eligibility Criteria

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Inclusion Criteria

* Patients with extraarticular distal radius fracture, proximal humerus fracture and Weber type B ankle fracture were treated conservatively during March 11, 2020 and 11 August, 2020

Exclusion Criteria

* Surgically treated patients during March 11, 2020 and 11 August, 2020
Minimum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Bulent KARSLIOGLU

Orthopedics and Traumatology specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SBU Prof. Cemil Tascioglu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

Reference Type BACKGROUND
PMID: 31986264 (View on PubMed)

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

Reference Type BACKGROUND
PMID: 31978945 (View on PubMed)

Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

Reference Type BACKGROUND
PMID: 32004427 (View on PubMed)

Chen YC, Lin WC. Risk of long-term infection-related death in clinical osteoporotic vertebral fractures: A hospital-based analysis. PLoS One. 2017 Aug 9;12(8):e0182614. doi: 10.1371/journal.pone.0182614. eCollection 2017.

Reference Type BACKGROUND
PMID: 28793342 (View on PubMed)

Mi B, Xiong Y, Lin Z, Panayi AC, Chen L, Liu G. COVID-19 Orthopaedic Safe Care Toolset: Guidelines for the Diagnosis and Management of Patients with Fracture and COVID-19. J Bone Joint Surg Am. 2020 Jul 1;102(13):1116-1122. doi: 10.2106/JBJS.20.00532.

Reference Type BACKGROUND
PMID: 32618909 (View on PubMed)

Guo X, Wang J, Hu D, Wu L, Gu L, Wang Y, Zhao J, Zeng L, Zhang J, Wu Y. Survey of COVID-19 Disease Among Orthopaedic Surgeons in Wuhan, People's Republic of China. J Bone Joint Surg Am. 2020 May 20;102(10):847-854. doi: 10.2106/JBJS.20.00417.

Reference Type BACKGROUND
PMID: 32271208 (View on PubMed)

Saxena A, Bullock M, Danoff JR, Rodd DS, Fischer SJ, Stronach BM, Levine BR. Educating Surgeons to Educate Patients About the COVID-19 Pandemic. J Arthroplasty. 2020 Jul;35(7S):S65-S67. doi: 10.1016/j.arth.2020.04.037. Epub 2020 Apr 18.

Reference Type BACKGROUND
PMID: 32340829 (View on PubMed)

Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.

Reference Type BACKGROUND
PMID: 32292899 (View on PubMed)

Handoll HH, Keding A, Corbacho B, Brealey SD, Hewitt C, Rangan A. Five-year follow-up results of the PROFHER trial comparing operative and non-operative treatment of adults with a displaced fracture of the proximal humerus. Bone Joint J. 2017 Mar;99-B(3):383-392. doi: 10.1302/0301-620X.99B3.BJJ-2016-1028.

Reference Type BACKGROUND
PMID: 28249980 (View on PubMed)

Orman S, Mohamadi A, Serino J, Murphy J, Hanna P, Weaver MJ, Dyer G, Nazarian A, von Keudell A. Comparison of surgical and non-surgical treatments for 3- and 4-part proximal humerus fractures: A network meta-analysis. Shoulder Elbow. 2020 Apr;12(2):99-108. doi: 10.1177/1758573219831506. Epub 2019 Feb 28.

Reference Type BACKGROUND
PMID: 32313559 (View on PubMed)

Maier D, Jaeger M, Izadpanah K, Strohm PC, Suedkamp NP. Proximal humeral fracture treatment in adults. J Bone Joint Surg Am. 2014 Feb 5;96(3):251-61. doi: 10.2106/JBJS.L.01293.

Reference Type BACKGROUND
PMID: 24500588 (View on PubMed)

Hertel R, Hempfing A, Stiehler M, Leunig M. Predictors of humeral head ischemia after intracapsular fracture of the proximal humerus. J Shoulder Elbow Surg. 2004 Jul-Aug;13(4):427-33. doi: 10.1016/j.jse.2004.01.034.

Reference Type BACKGROUND
PMID: 15220884 (View on PubMed)

Murray IR, Amin AK, White TO, Robinson CM. Proximal humeral fractures: current concepts in classification, treatment and outcomes. J Bone Joint Surg Br. 2011 Jan;93(1):1-11. doi: 10.1302/0301-620X.93B1.25702.

Reference Type BACKGROUND
PMID: 21196536 (View on PubMed)

Martin AG. Weber B ankle fracture: an unnecessary fracture clinic burden. Injury. 2004 Aug;35(8):805-8. doi: 10.1016/j.injury.2003.12.013.

Reference Type BACKGROUND
PMID: 15246805 (View on PubMed)

Mittal R, Harris IA, Adie S, Naylor JM; CROSSBAT Study Group. Surgery for Type B Ankle Fracture Treatment: a Combined Randomised and Observational Study (CROSSBAT). BMJ Open. 2017 Mar 27;7(3):e013298. doi: 10.1136/bmjopen-2016-013298.

Reference Type BACKGROUND
PMID: 28348185 (View on PubMed)

Van Schie-Van der Weert EM, Van Lieshout EM, De Vries MR, Van der Elst M, Schepers T. Determinants of outcome in operatively and non-operatively treated Weber-B ankle fractures. Arch Orthop Trauma Surg. 2012 Feb;132(2):257-63. doi: 10.1007/s00402-011-1397-z. Epub 2011 Sep 30.

Reference Type BACKGROUND
PMID: 21959696 (View on PubMed)

Young BT, Rayan GM. Outcome following nonoperative treatment of displaced distal radius fractures in low-demand patients older than 60 years. J Hand Surg Am. 2000 Jan;25(1):19-28. doi: 10.1053/jhsu.2000.jhsu025a0019.

Reference Type BACKGROUND
PMID: 10642469 (View on PubMed)

Chang HC, Tay SC, Chan BK, Low CO. Conservative treatment of redisplaced Colles' fractures in elderly patients older than 60 years old - anatomical and functional outcome. Hand Surg. 2001 Dec;6(2):137-44. doi: 10.1142/s0218810401000606.

Reference Type BACKGROUND
PMID: 11901459 (View on PubMed)

Fujii K, Henmi T, Kanematsu Y, Mishiro T, Sakai T, Terai T. Fractures of the distal end of radius in elderly patients: a comparative study of anatomical and functional results. J Orthop Surg (Hong Kong). 2002 Jun;10(1):9-15. doi: 10.1177/230949900201000103.

Reference Type BACKGROUND
PMID: 12401915 (View on PubMed)

Anzarut A, Johnson JA, Rowe BH, Lambert RG, Blitz S, Majumdar SR. Radiologic and patient-reported functional outcomes in an elderly cohort with conservatively treated distal radius fractures. J Hand Surg Am. 2004 Nov;29(6):1121-7. doi: 10.1016/j.jhsa.2004.07.002.

Reference Type BACKGROUND
PMID: 15576226 (View on PubMed)

Other Identifiers

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Treatment in the time of Covid

Identifier Type: -

Identifier Source: org_study_id