Tibia shaft fractures
Conditions
Interventions
1) Longitudinal incision and insertion of tibia nail using a transpatellar approach
2) Transverse incision and insertion of tibia nail using a transpatellar approach
Sponsors
Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of Surgery
Erasmus Medical Center, Medical Research Ethics Committee (MREC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 16 and 65 years 2.Unilateral tibial shaft fracture (AO 42 A, B and C) 3. Indication for intramedullary nailing in judgment of the treating surgeon (within 2 weeks after initial trauma) 4. Provided written consent by patient
Exclusion criteria
Exclusion criteria: 1. Polytrauma patients, when concurring injury affect treatment and recovery 2. Patients with bilateral tibial fractures 3. Patients with a pathological or recurrent fracture of the tibia 4. Gustilo open fractures grade C or open wound on knee 5. Patients with pre-existing knee pathology (e.g., menisci, cruciate ligament) 6. Patients with pre-existing functional impairment which has influence on rehabilitation (e.g. wheelchair-bound) 7. Patients with rheumatoid arthritis 8. Patients with bone disease resulting in delayed union (except osteoporosis) 9. Insufficient comprehension of Dutch language to adhere to treatment guidelines 10. Likely problems with follow-up (e.g., no fixed address)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kneeling pain (Numeric Rating Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee pain scores (NRS) for specific daily activities (including running, walking, jumping, stair climbing, squatting, sitting with flexed knees, and cycling); Functional outcome and health-related quality of life (SMFA and LEFS); Time to return to daily activities and work; Costs for health care and production losses; Range of motion of the knee and ankle; Nail prominence; Rate of complications; Rate of secondary interventions; Cosmesis (5-point scale); Cost-effectiveness | — |
Contacts
Public ContactM.H.J. Verhofstad
Erasmus MC, Trauma Research Unit, dept. of Surgery - Mailbox H-822k 's-Gravendijkwal 230, 3015 CE Rotterdam
Outcome results
None listed