Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures
- Conditions
- Tibial Shaft Fracture
- Interventions
- Procedure: External Ring fixationProcedure: Intramedullary Nailing
- Registration Number
- NCT03945669
- Lead Sponsor
- Aalborg University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- Fracture of the tibial shaft
- OTA classification Type: 42-A1-A3, -B1-B3 and -C1-C3
- The fracture type is deemed operable by intramedullary nail
- Below 18 years of age
- Open fracture
- History of severe systemic diseases or cancer
- Bilateral tibial shaft fracture
- Multi fracture patients
- Pregnancy
- Patients without gait function prior to fracture
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description External Ring fixator External Ring fixation External Ring fixation: Closed or limited open reduction of the fracture is performed. A circular frame is attached on both sides of the fracture. Connection to the bone is obtained by hydroxyapatite coated half pins and/or k-wires with olives as needed according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. After applying the ring fixator alignment is assessed radiologically and corrected both peri- and postoperatively. Patients are administered preoperative antibiotics (Dicloxacillin) preoperatively 15 minutes before surgery commences. Following surgery antibiotics are continued until wounds, pin- and wire perforations are dry. Intramedullary Nail Intramedullary Nailing Intramedullary Nailing: Alignment will be obtained by closed or limited open reduction of the fracture. A standard reamed intramedullary nail is inserted. Access above the patella, through the patella tendon or parapatellar access is used according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. Patients are administered preoperative antibiotics (Dicloxacillin) 15 minutes before surgery commences. Postoperative antibiotics is administered by discretion of the surgeon based on individual patient considerations.
- Primary Outcome Measures
Name Time Method The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport) 12 month follow up 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.
- Secondary Outcome Measures
Name Time Method Patient Acceptable Symptom State (PASS) 3+6+12 months This instrument evaluate when the patient reaches a acceptable patient observed pain and function level, where the patient no longer demands treatment
Patient-reported pain reactions 6 weeks, 3+6+12 months 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.
Pain sensitivity 6 weeks, 3+6+12 months Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).
Radiological alignment 6 weeks, 3+6+12 months Alignment of the tibia will be evaluated using the EOS scanning system.
Health related QOL 6 weeks, 3+6+12 months 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
Health economic evaluation 12 months Measure the cost of treatment in the two groups within the first year following surgery
Perceived Pain 6 weeks, 3+6+12 months 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.
Gait assessment 3+6+12 months Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.
Muscle strength 6+12 months 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 to bone union 6 weeks, 3+6+12 months 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.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) 6 weeks, 3+6+12 months 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 to return to work 6 weeks, 3+6+12 months Measure the time from surgery to end of sick leave measured in days.
Foot And Ankle Outcome Score (FAOS) 6 weeks, 3+6+12 months 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.
Trial Locations
- Locations (3)
Aalborg University Hospital, Department of orthopaedic surgery
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Regional Hospital Viborg
🇩🇰Viborg, Denmark