Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202307910320431 Date of Registration: 26/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Building Bridges for Broken Bones
Official scientific title The Collaborative Fracture Management Study: Safety, acceptability & efficacy of a collaborative triage & treatment model for extremity fracture patients in rural Tanzania, involving traditional bone setters: a feasibility trial
Brief summary describing the background and objectives of the trial Extremity fractures constitute a substantial burden among patients seeking care in LMICs. However, in most rural areas, access to orthopaedic trauma care is severely lacking, leading to most fracture patients seeking out traditional treatment. Consequently, fracture patients often go without adequate pain treatment and X-ray diagnostics, and those with complex fractures may develop crippling complications. There is a need to develop, implement and study approaches that can optimize outcomes of extremity fracture treatment in rural areas. Regional trauma care could greatly benefit from combining the best elements of both traditional bonesetting and hospital care, by developing a single, standardized and collaborative triage & treatment model for fracture management. In this model, the TBS and hospital workers cooperate by triaging fracture patients by pre-defined criteria, with the aim to provide conservative and local treatment where possible, surgical treatment at the hospital when needed, and adequate pain medication and X-ray imaging for all. Such a model has the potential, in a culturally appropriate way, to improve access to surgical trauma care for extremity fracture patients and thereby functional outcomes. By setting up collaborative fracture management between the formal healthcare sector and traditional bonesetters, our research aims to: - Reduce fracture-related complications and pain for all fracture patients - Gain insight into the safety and efficacy of traditional bonesetting - Strengthen the local healthcare workforce through integration of skilled bonesetters
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 21/08/2023
Actual trial start date 28/08/2023
Anticipated date of last follow up 31/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard traditional bonesetter treatment Dependent on fracture type Fracture reduction done at bonesetter practice, splinting with local materials (e.g. wood, cloth) and daily massage with herbal ointment. 38 Active-Treatment of Control Group
Experimental Group Collaborative fracture management Dependent on fracture type Pain medication (according to WHO Pain Ladder), X-ray imaging for all patients, if indicated surgical wound management and/or reduction under local or general anesthesia. Using the AO Surgical Reference, a joint decision is then made by referring bonesetter and medical doctor for either conservative treatment at the bonesetter, or initial surgical treatment at the hospital, followed by monitoring at the bonesetter. 37
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with fractures involving the arms and legs (hand, radius/ulna, humerus, clavicle, foot, tibia/fibula, femur, hip) - Patient age between 4-85 years old - Within 6 weeks post-injury - Conversational in Kiswahili - Reduced consciousness and possible neurotrauma (EMV score <12) - Polytrauma, with evidence of organ damage or Injury Severity Score ≥12 - Inability to provide written informed consent 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 4 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/07/2023 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11101 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Self-reported pain, using 5-point Likert scale Presentation, 6 weeks, 3 months and 6 months post-injury
Primary Outcome Number of general and fracture-related complications, e.g. death, osteomyelitis, gangrene, compartment syndrome, mal/non-union. Severity of complications will be graded according to the ASOS definitions. Presentation, 6 weeks, 3 months and 6 months post-injury
Secondary Outcome Functional range-of-motion, yes or no Presentation, 6 weeks, 3 months and 6 months post-injury
Secondary Outcome Weight-bearing, yes/no Presentation, 6 weeks, 3 months and 6 months post-injury
Secondary Outcome Return to school/work, yes/no Presentation, 6 weeks, 3 months and 6 months post-injury
Secondary Outcome Disability, using WHODAS 2.0 questionnaire Presentation, 6 weeks, 3 months and 6 months post-injury
Secondary Outcome Quality of life, using EQ-5D-5L questionnaire Presentation, 6 weeks, 3 months and 6 months post-injury
Secondary Outcome Patient satisfaction, using 5-point Likert scale 6 months post-injury
Secondary Outcome Loss of work/income, using Short Financial Impact Assessment questionnaire 6 months post-injury
Secondary Outcome Protocol adherence End of study
Secondary Outcome Protocol adherence End of study
Secondary Outcome Cost of treatment 6 weeks, 3 months and 6 months post-injury
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shirati KMT Hospital Kabwana Shirati 1018 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Nationaal Albert Schweitzer Fonds Joseph Haydnlaan 2-A Utrecht 3533 AE Netherlands
Otto Kranendonk Fonds Postbus 43 Wijhe 8130 AA Netherlands
Global Surgery Foundation 11 bis rue Rodolphe-Toepffer Geneva 1206 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shirati KMT Hospital Kabwana Shirati Tanzania Hospital
COLLABORATORS
Name Street address City Postal code Country
Global Surgery Amsterdam Tafelberg 47 Amsterdam 1105 BD Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bwire Chirangi bmchirangi@yahoo.co.uk +255784538740 Kabwana
City Postal code Country Position/Affiliation
Shirati Tanzania Medical superintendent of Shirati KMT Hospital
Role Name Email Phone Street address
Public Enquiries Nefti Bempong n.bempong@globalsurgeryfoundation.org +41786719302 11 bis rue Rodolphe-Toepffer
City Postal code Country Position/Affiliation
Geneva Switzerland Project Manager
Role Name Email Phone Street address
Scientific Enquiries Joost Binnerts joostbinnerts@gmail.com +31657123583 Kabwana
City Postal code Country Position/Affiliation
Shirati Tanzania Research coordinator
Role Name Email Phone Street address
Scientific Enquiries Thom Hendriks thom.hendriks@gmail.com +31612030161 Kruisbergseweg 25
City Postal code Country Position/Affiliation
Doetinchem Netherlands Surgeon in training at Slingeland Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after anonymized. Partner bonesetters will also be deintified. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 3 months following publication. No end date. Anyone who wishes to access the data. For any scientific purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information