Table 2.
Timetable and description of the preoperative and follow-up evaluation.
| Outcome measure | Definition | Score | Preoperative evaluation | 3-month follow-up | 6-month follow-up | 1 month after Ilizarov removal | Every 6 months up to the end of follow-up period (minimum 3 years) | |
| Patient-reported | ||||||||
|
|
PNRSa | Pain Numerical Rating Scale | 0-10 | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
AOFASb ankle-hindfoot score | Foot and ankle–specific score | 0-100 | ✓ |
|
|
✓ | ✓ |
|
|
KOS-ADLSc | Knee-specific score | 0-70 and 0-55 | ✓ |
|
|
✓ | ✓ |
|
|
AAOSd Lower Limb Scale | General lower limb condition | 0-80 | ✓ |
|
|
✓ | ✓ |
|
|
EQ-5D-3L | Health-related quality of life | 5-15 (less the better) | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
QALYe Time Trade-Off | Quality of life | N/Af | ✓ |
|
|
✓ | 6 months after Ilizarov removal |
|
|
SF-12g and SF-6D | General health questionnaire and QALY from the SF-12 | Physical and mental component scores | ✓ | ✓ | ✓ | ✓ | 6 months after Ilizarov removal |
| Objective measures | ||||||||
|
|
Limb discrepancy | Limb length normalization is one of the goals (fracture healing and infection eradication are the others) | N/A | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
Radiographic evaluation of bone healing | Fracture union and restoration of bone axis | N/A | ✓ | Every month | Every month | Every month | ✓ |
|
|
External fixation index | Time in external fixation / length of bone regenerated (months/cm) | N/A |
|
After Ilizarov removal | After Ilizarov removal | After Ilizarov removal |
|
|
|
Laboratory infection markers (CRPh, WBCi, ESRj, liver and kidney function) | Comorbidities and side effects due to the antibiotic therapy | N/A | ✓ | Every month | Every month | Every month | ✓ |
|
|
ASAMIk scoring system (bone and functional) | Bone quality and functional results | Excellent, good, fair, or poor | ✓ |
|
|
✓ | ✓ |
| Complications | N/A | N/A | Intraoperative | Reported each and any time they appeared | Reported each and any time they appeared | Reported each and any time they appeared | Reported each and any time they appeared | |
aPNRS: Pain Numerical Rating Scale.
bAOFAS: American Orthopaedic Foot and Ankle Society.
cKOS-ADLS: Knee Outcome Survey- Activity of Daily Living Scale.
dAAOS: American Academy of Orthopaedic Surgeons.
eQALY: Quality Adjust Life Year.
fN/A: not applicable.
gSF: Short-Form.
hASAMI: Association for the Study and Application of the Methods of Ilizarov.
iCRP: C-reactive protein.
jWBC: white blood cell count.
kESR: erythrocyte sedimentation rate.