This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures. The primary aim of the project is to compare the one-year Knee Injury and Osteoarthritis Outcome Score - Sport (KOOS-Sport) after standard intramedullary nailing with external ring fixation for patients with tibial shaft fractures. The explorative aim is to report the effect of the two surgical procedures on the development of complications, time to bone union, pain reactions, muscle strength, activity of daily living and time to return to work.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
67
fracture fixation of the tibial shaft fracture with an intramedullary nail.
fracture fixation of the tibial shaft fracture with an external ring fixator.
Aalborg University Hospital, Department of orthopaedic surgery
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Regional Hospital Viborg
Viborg, Denmark
The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)
KOOS-sport is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems with regards to activity. The subscale sport is one five subscales: pain, ADL, symptoms, sport and QOL in the KOOS questionnaire . A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
Time frame: 12 month follow up
Perceived Pain
Development in pain in the two groups will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.
Time frame: 6 weeks, 3+6+12 months
Patient-reported pain reactions
Pain DETECT questionnaire. The painDETECT screening questionnaire (PD-Q), uses a scoring method between - 1 and 38 to estimate the likelihood of a neuropathic pain component in patients.
Time frame: 6 weeks, 3+6+12 months
Pain sensitivity
Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).
Time frame: 6 weeks, 3+6+12 months
Muscle strength
Isometric muscle strength in the two groups will be measured by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK). Girth measures of thigh and calf will be used to examine muscle atrophy and/or effusion
Time frame: 6+12 months
Time to bone union
Bone union, in the two surgical groups will be evaluated on standard AP and side X-rays of the fractured leg. The evaluation of bone union will be defined as: i) visible callus formation on at least three of four sides, no visible fracture line and no pain from fracture site at weight-bearing and during clinical examination.
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Time frame: 6 weeks, 3+6+12 months
Radiological alignment
Alignment of the tibia will be evaluated using the EOS scanning system.
Time frame: 6 weeks, 3+6+12 months
Health related QOL
Eq5D-5L is a standardized questionnaire developed to assess general health outcome (29). It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death
Time frame: 6 weeks, 3+6+12 months
Time to return to work
Measure the time from surgery to end of sick leave measured in days.
Time frame: 6 weeks, 3+6+12 months
Health economic evaluation
Measure the cost of treatment in the two groups within the first year following surgery
Time frame: 12 months
Gait assessment
Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.
Time frame: 3+6+12 months
Patient Acceptable Symptom State (PASS)
This instrument evaluate when the patient reaches a acceptable patient observed pain and function level, where the patient no longer demands treatment
Time frame: 3+6+12 months
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems.The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
Time frame: 6 weeks, 3+6+12 months
Foot And Ankle Outcome Score (FAOS)
FAOS is a standardized and validated patient-reported instrument used in order to assess foot and ankle associated problems divided into 5 subscales. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
Time frame: 6 weeks, 3+6+12 months