NCT04623346

Brief Summary

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 7, 2020

Last Update Submit

November 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of the two groups in terms of bony union

    The investigators aimed to investigate the duration of bone union time between two groups

    12 week

Study Arms (6)

Weber B-type Ankle fractures in prepandemic period

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

Weber B-type Ankle fractures in pandemic period

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

Procedure: Observation for study group

Wrist fractures in prepandemic period

Patients with extraarticular distal radius fracture in prepandemic period

Wrist fractures in pandemic period

Patients with extraarticular distal radius fracture in pandemic period

Procedure: Observation for study group

Proximal humerus fractures in prepandemic period

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

Proximal humerus fractures in pandemic period

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

Procedure: Observation for study group

Interventions

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

Also known as: Surgery for control group
Proximal humerus fractures in pandemic periodWeber B-type Ankle fractures in pandemic periodWrist fractures in pandemic period

Eligibility Criteria

Age85 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who admitted to emergency orthopedics department between March 11, 2020 and August 11, 2020

You may qualify if:

  • 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

You may not qualify if:

  • Surgically treated patients during March 11, 2020 and 11 August, 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU Prof. Cemil Tascioglu City Hospital

Istanbul, 34040, Turkey (Türkiye)

Location

Related Publications (20)

  • 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.

    PMID: 31986264BACKGROUND
  • 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.

    PMID: 31978945BACKGROUND
  • 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.

    PMID: 32004427BACKGROUND
  • 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.

    PMID: 28793342BACKGROUND
  • 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.

    PMID: 32618909BACKGROUND
  • 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.

    PMID: 32271208BACKGROUND
  • 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.

    PMID: 32340829BACKGROUND
  • 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.

    PMID: 32292899BACKGROUND
  • 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.

    PMID: 28249980BACKGROUND
  • 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.

    PMID: 32313559BACKGROUND
  • 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.

    PMID: 24500588BACKGROUND
  • 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.

    PMID: 15220884BACKGROUND
  • 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.

    PMID: 21196536BACKGROUND
  • 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.

    PMID: 15246805BACKGROUND
  • 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.

    PMID: 28348185BACKGROUND
  • 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.

    PMID: 21959696BACKGROUND
  • 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.

    PMID: 10642469BACKGROUND
  • 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.

    PMID: 11901459BACKGROUND
  • 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.

    PMID: 12401915BACKGROUND
  • 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.

    PMID: 15576226BACKGROUND

MeSH Terms

Conditions

Ankle FracturesShoulder FracturesWrist Fractures

Interventions

ObservationSurgical Procedures, OperativeControl Groups

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg InjuriesShoulder InjuriesWrist InjuriesArm Injuries

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesEpidemiologic Research DesignEpidemiologic MethodsResearch Design

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedics and Traumatology specialist

Study Record Dates

First Submitted

November 7, 2020

First Posted

November 10, 2020

Study Start

March 11, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations