INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

Completed

• Conditions: Fractures or Dislocations

• Registration Number: NCT02150980
• Lead Sponsor: McMaster University

Brief Summary

Background: Worldwide, injuries from trauma represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is little empirical data in low and middle-income countries quantifying the burden of musculoskeletal injuries.

Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The primary objective of the study is to determine the mortality, re-operation and infection rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and Latin America.

Detailed Description

Number of Participants:

40,000

Primary Research Objectives:

To determine among adult individuals admitted to hospital with musculoskeletal trauma (e.g. fractures or dislocations):

1. The incidence of major complications (mortality, re-operation and infection) as a composite outcome and the components of the composite within 30 days post-hospital admission.

2. The factors (system and patient variables) associated with the composite of major complications (mortality, re-operation and infection) within 30 days post-hospital admission.

Secondary Research Objective:

To determine the rates of major complications within 30 days post-hospital admission by type of fracture treatment provided (e.g. splinting versus operative fixation) and admission to hospital time (e.g. \<72 hours or \> 72 hours).

Diagnosis and Main Inclusion Criteria:

This study has minimal exclusion criteria by design. All patients 18 years of age or older admitted to a recruiting hospital for treatment of an orthopaedic injury that occurred within 3 months will be eligible for participation. Patients who are diagnosed with an orthopaedic fracture, dislocation, or fracture dislocation of the appendicular skeleton or spine will be included.

Study Outcomes:

The primary outcome is a composite of mortality, mortality, re-operation and infection within 30 days from hospital admission for all research objectives.

Duration of Patient Follow-Up:

Study participants will be followed until 30 days post hospital admission.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-30
• Primary Completion: 2023-11
• Study Completion: 2023-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39797

Inclusion Criteria

• patients 18 years of age or older
• admitted to a recruiting hospital for treatment of an orthopaedic injury
• injury occurred within 3 months of hospital admission
• patients diagnosed with an orthopaedic fracture, dislocation, or fracture dislocation of the appendicular skeleton or spine will be included.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality, re-operation and infection	30 days post-hospital admission

Trial Locations

Locations (68)

Clínica Zabala; 🇦🇷 Buenos Aires, Argentina

Indira Ganghi Medical College; 🇮🇳 Puducherry, India

Philippine General Hospital; 🇵🇭 Manila, Philippines

Hospital de Beneficencia Sirio-Libanes; 🇧🇷 San Paolo, Brazil

Charlotte Maxete Johannesburg Acadamic Hospital; 🇿🇦 Johannesburg, South Africa

Princess Marina Hospital; 🇧🇼 Gaborone, Botswana

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Clinica Fracturas y Fracturas; 🇨🇴 Pereira, Colombia

Black Lion Hospital; 🇪🇹 Addis Ababa, Ethiopia

Baptist Christian Hospital; 🇮🇳 Tezpur, Assam, India

St John Medical College; 🇮🇳 Bangalore, India

Komfo Anokye Teaching Hospital (KATH); 🇬🇭 Kumasi, Ghana

Chris Hani Baragwanath Acadamic Hospital; 🇿🇦 Johannesburg, South Africa

Noble Hospital; 🇮🇳 Pune, India

Sancheti Institute for Orthopaedics and Rehabilitation; 🇮🇳 Pune, India

Sina Trauma and Surgery Research Center/University of Tehran; 🇮🇷 Tehran, Iran, Islamic Republic of

Viet Duc Hospital; 🇻🇳 Hanoi, Vietnam

Cho Ray Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Hospital de Clínicas - UNICAMP; 🇧🇷 São José dos Campos, Brazil

Shanghai No.10 People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Medical College & Hospital, Bharati Vidyapeeth Deemed University; 🇮🇳 Pune, India

Rift Valley provincial hospital; 🇰🇪 Karuru One, Kenya

Kiambu District Hospital; 🇰🇪 Kiambu, Kenya

Hospital Santo Tomás; 🇵🇦 Panama city, Panama

Helen Joseph Hospital; 🇿🇦 Johannesburg, South Africa

Muhimbili Orthopaedic Institute; 🇹🇿 Dar es Salaam, Tanzania

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China

Xiamen University affiliated First Hospital; 🇨🇳 Xiamen, Fujian, China

Langfang Aidebao General Hospital; 🇨🇳 Langfang, Hebei, China

Langfang People's Hospital; 🇨🇳 Langfang, Hebei, China

Beijing Luhe Hospital; 🇨🇳 Beijing, Beijing, China

Harbin Medical University Second hospital; 🇨🇳 Harbin, Heilongjiang, China

Second Bethune Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Hanzhong People's Hospital; 🇨🇳 Hanzhong, Shaanxi, China

Shenyang Orthopaedic Hospital; 🇨🇳 Shenyang, Liaoning, China

Tianjin Hospital; 🇨🇳 Tianjin, Tianjin, China

The 2nd affiliated hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Mulago Hospital, Makerere University College of Health Sciences; 🇺🇬 Kampala, Uganda

Fort Portal Regional Referral Hospital; 🇺🇬 Fort Portal, Uganda

University of Malawi; 🇲🇼 Blantyre, Malawi

National Orthopaedic Hospital Enugu; 🇳🇬 Enugu, Nigeria

Instituto de Prevision Social - Central Hospital; 🇵🇾 Asunción, Paraguay

Hospital Puerta de Hierro; 🇲🇽 Jalisco, Mexico

CMC Vellore; 🇮🇳 Vellore, India

Centro Médico Imbanaco; 🇨🇴 Cali, Colombia

Dr L H Hiranandani Hospital; 🇮🇳 Mumbai, India

AIC Kijabe Hospital; 🇰🇪 Kijabe, Kenya

Christus Muguerza Hospital Saltillo; 🇲🇽 Saltillo, Mexico

Lumbini Medical College; 🇳🇵 Kathmandu, Nepal

Kilimanjaro Christian Medical Centre; 🇹🇿 Moshi, Tanzania

AIIMs Hospital; 🇮🇳 Delhi, India

Indian Institue for Spinal Care; 🇮🇳 Delhi, India

Social Security Hospitals; 🇲🇽 Mexico City, Mexico

Hospital Civil de Guadalajara; 🇲🇽 Guadalajara, Mexico

Smt N H L Municipal Medical College; 🇮🇳 Gujrat, Ahmedabad, India

Data Meghe Institute of Medical Sciences; 🇮🇳 Wardha, India

Baptist Hospital Mutengene; 🇨🇲 Mutengene, Cameroon

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India

University Teaching Hospital; 🇷🇼 Kigali, Rwanda

Hospital Universitario de Caracas; 🇻🇪 Caracas, Venezuela

CMC Ludhiana; 🇮🇳 Ludhiana, India

Social Security Hospital; 🇲🇽 Monterrey, Mexico

State trauma and surgical centre; 🇳🇬 Ondo, Nigeria

Northwest General Hospital & Research Centre; 🇵🇰 Peshawar, Pakistan

Khon Kaen Hospital; 🇹🇭 Khon Kaen, Thailand

Kenyatta National Hospital; 🇰🇪 Nairobi, Kenya