AEFIX Rwanda RCT — Participant Workflow
Sequential participant journey from consent through follow-up. Tap any QR code or its label to open that form.
Consent & Screening
Captures. Perform consent in person, then confirm it on Form 01. Screen for eligibility, register the patient, auto-generate Study ID (AEFIX-SITE-XXXX).
Enrollment (baseline)
Captures. Demographics, injury characteristics, AO/OTA classification, baseline EQ-5D-5L and LEFS.
Randomization occurs in theatre and is captured at the top of the Intra-operative form. Obtain allocation as AEFIX vs local, recorded in Form 03.
Intra-operative
Captures. Surgical and fixator details, uploads, adverse-event trigger.
- Immediate post-op x-rays (the reduction baseline every later film is compared against)
- Photo of the completed intra-op frame / construct
- Adverse event complete Form 06 — Adverse Event
- Imaging to add x-rays that were not available when this form was submitted, upload them later with Form 07 — Imaging Upload
- Media for extra photos, use Form 08 — Additional Photo Upload
Hospital Discharge
Captures. Hospitalization details recorded at discharge: length of stay, in-hospital complications, and adverse-event trigger. If a form needs completion, either edit the submitted form or add a new record.
- Discharge x-rays only if obtained. No routine film is required at discharge.
- Adverse event complete Form 06 — Adverse Event
- Imaging to add x-rays that were not available when this form was submitted, upload them later with Form 07 — Imaging Upload
- Media for extra photos, use Form 08 — Additional Photo Upload
Scheduled follow-up
Captures. EQ-5D-5L, LEFS, FIX-IT, RUST, radiographs, complications, adverse-event trigger at each follow-up time point.
- RUST x-rays at every follow-up visit (6wk, 3mo, 6mo, 12mo)
- Final x-rays taken just before fixator removal (the primary-outcome comparator to the post-op baseline)
- Adverse event complete Form 06 — Adverse Event
- Imaging to add x-rays that were not available when this form was submitted, upload them later with Form 07 — Imaging Upload
- Media for extra photos, use Form 08 — Additional Photo Upload
Study completion (12 months)
Final scheduled time point completes the participant journey.
On-demand forms
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