Ankle FracturesNCT04623346
Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic
An observational study of Ankle Fractures and Proximal Humeral Fracture, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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? Read more about this study
- Who is it for?
- Ages 85 years and older
- Conditions the study is for
- Ankle Fractures, Proximal Humeral Fracture, Wrist Fracture
- What is being tested?
- Observation for study group
- Type of treatment
- Surgery or procedure
- How many people
- 262 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 85 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who admitted to emergency orthopedics department between March 11, 2020 and August 11, 2020
Who may be able to join
- 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
Who cannot join
- Surgically treated patients during March 11, 2020 and 11 August, 2020
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Prof. Cemil Tascioglu City Hospital
Istanbul, 34040
About this study
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?
Read the detailed description
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
- Ankle Fractures, Proximal Humeral Fracture, Wrist Fracture
- Being tested
- Observation for study group
- Medical subject headings
- Ankle Fractures, Shoulder Fractures, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation for study groupProcedure or surgery
Also called Surgery for control group
Patients with Weber B-type Ankle fractures, extraarticular wrist fractures and proximal humerus fractures were followed with conservative manner( cast or sling)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Observation for study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the two groups in terms of bony union
The investigators aimed to investigate the duration of bone union time between two groups
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start11 Mar 2020
- Primary completion1 Nov 2020
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent KARSLIOGLU, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623346
- Sponsor's protocol ID
- Treatment in the time of Covid
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31986264Zhu 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.
PubMed 31978945Holshue 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.
PubMed 32004427Chen 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.
PubMed 28793342Mi 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.
PubMed 32618909Guo 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.
PubMed 32271208Saxena 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.
PubMed 32340829Lei 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.
PubMed 32292899Handoll 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.
PubMed 28249980Orman 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.
PubMed 32313559Maier 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.
PubMed 24500588Hertel 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.
PubMed 15220884Murray 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.
PubMed 21196536Martin 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.
PubMed 15246805Mittal 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.
PubMed 28348185
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04623346
- Acronym / sponsor ID
- Treatment in the time of Covid
- Conditions
- Ankle Fractures, Proximal Humeral Fracture, Wrist Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: Observation for study groupPatients with AO Weber B-type ankle fracture in pandemic period |
| Wrist fractures in prepandemic period | – | –Patients with extraarticular distal radius fracture in prepandemic period |
| Wrist fractures in pandemic period | – | Procedure: Observation for study groupPatients with extraarticular distal radius fracture in pandemic period |
| 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 | – | Procedure: Observation for study groupPatients with 2-part,3-part and 4-part fractures in pandemic period |
Who may qualify
- Ages
- 85 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who admitted to emergency orthopedics department between March 11, 2020 and August 11, 2020
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Surgically treated patients during March 11, 2020 and 11 August, 2020
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation for study groupAlso: Surgery for control groupPatients with Weber B-type Ankle fractures, extraarticular wrist fractures and proximal humerus fractures were followed with conservative manner( cast or sling) | Procedure or surgery | Proximal humerus fractures in pandemic period, Weber B-type Ankle fractures in pandemic period, Wrist fractures in pandemic period |
Primary outcome
Comparison of the two groups in terms of bony union
Time frame: 12 week
The investigators aimed to investigate the duration of bone union time between two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Background: PubMed 31986264Huang 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.
- Background: PubMed 31978945Zhu 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.
- Background: PubMed 32004427Holshue 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.
- Background: PubMed 28793342Chen 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.
- Background: PubMed 32618909Mi 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.
- Background: PubMed 32271208Guo 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.
- Background: PubMed 32340829Saxena 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.
- Background: PubMed 32292899Lei 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.
- Background: PubMed 28249980Handoll 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.
- Background: PubMed 32313559Orman 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.
- Background: PubMed 24500588Maier 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.
- Background: PubMed 15220884Hertel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fractures and Proximal Humeral Fracture, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the two groups in terms of bony union (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623346, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.