Femur or tibia fractures
Conditions
Interventions
Study Setting:
The study will take place at three clinical sites in the Northern Province of Sri Lanka, including Teaching Hospital, Jaffna, District General Hospital Vavuniya, and District General H
Sponsors
A/Prof. Denny Lie Tjiauw Tjoen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females 18 years of age or older. 2. Closed or open fractures of the femur and/or tibia, including fractures of the proximal femur, femoral diaphysis, extra-articular and intra-articular fractures of the distal femur and proximal tibia, tibia diaphysis, and extra-articular and intra-articular fractures of the distal tibia including pilon and ankle fractures. 3. Fractures not amenable to internal fixation due to risk of infection, inadequate soft tissue coverage, severe soft tissue trauma, or patient hemodynamic instability, and therefore indicated for external fixation by the treating surgeon (participating surgeon or delegate at a study site will perform all planned surgeries).
Exclusion criteria
Exclusion criteria: 1. Patients with established fracture malunions or nonunion. 2. Patients with established chronic osteomyelitis or pathologic fractures. 3. Patients undergoing limb deformity correction or bone transport. 4. Patients with periprosthetic fractures. 5. Medical or injury contraindication to external fixation, for example severe immunocompromised state in which risk of pin tract infection outweighs the benefit of external fixation, in the context of a patient’s specific presentation and history. 6. Patient incarceration. 7. Patients currently enrolled in a study that does not permit co-enrollment. 8. Unable to obtain informed consent due to language barriers. 9. Anticipated problems with maintaining follow-up with the patient, including for eventual external fixation removal, and compliance with pin site care, in the judgement of research personnel. 10. Prior enrollment in the study when considering a new fracture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of fracture reduction as measured on X-rays taken immediately after external fixation application and subsequent X-rays until removal. Objective Criteria: X-rays will be done post-operative and compared to when the external fixator is removed. Fracture reduction alignment, angulation, fracture gap, and degree of displacement will be measured and compared between initial and subsequent X-rays. [X-rays will be taken within 24 hours post-operatively and repeated up to 48 hours before removal of the external fixator.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of clinical complications (pin tract infections, superficial/deep infection, iatrogenic neurovascular injuries, malunion/nonunion, amputation, death) [6 weeks, 3 months, and 6 months post-operatively.] Quality of life as measured by the EQ-5D instrument. Quality of life as measured by the EQ-5D instrument, which includes the following broad components: • Mobility • Self-care • Usual activities • Pain/discomfort • Anxiety/depression [ 6 weeks, 3 months, and 6 months post-operatively.] Clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument. Clinical fracture healing assessed using the FIX-IT includes the following components: • Weight Bearing - Single Leg Stand Score - Ambulation Score • Pain - Palpation Score - Stress Score [ 6 weeks, 3 months, and 6 months post-operatively.] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Sreekanthan Gobishangar
Senior Lecturer and Consultant Surgeon
Outcome results
None listed