Secondary outcome parameters
Incidence of avascular necrosis: AVN is defined as hip pain in combination with radiographical signs for AVN as described by Steinberg [
19]. According to the Steinberg classification AVN is present from stage 2 and upward. AVN will be assessed by the treating surgeon. As is customary in the Netherlands, all radiographs are also assessed by a radiologist.
Incidence of non-union: there is no consensus in the literature regarding to the definition of (non-)union [
20]. Our definition of non-union is based on the Radiographic Union Score for Hip (RUSH) [
21]. Non-union is a visible fracture line on the radiograph, absence of cortical bridging or bridging trabeculae over the fracture site in combination with persisting pain in the hip and the inability to bear weight at least 9 months post-operative or sooner if revision surgery was performed because it was no longer expected that fracture healing would occur. Non-union will be assessed by the treating surgeon.
Incidence of implant related complications: an implant related complication is defined as breakage or cut-out of the plate or screws, inadequate expansion/malfunction of the anchors or any malfunction of the implant which may or may not lead to revision surgery. Implant related failure will be monitored during 1 year of follow up.
Post-operative complications: post-operative complication is defined as any unanticipated event other than the above mentioned, for which operative treatment or medical treatment is required, e.g. wound infection, bleeding or pneumonia. Every complication occurring during the hospital stay of the patient will be recorded.
Rate of elective implant removal after union: Elective implant removal after union will be recorded during 1 year of follow up after surgery. Reasons for elective removal will be described.
Functional outcome: patient-reported post-surgical function will be scored using the validated Dutch version of the International Hip Outcome Tool (iHOT-12NL) [
22]. The iHOT-12NL is a patient-reported questionnaire that measures health-related quality of life and physical function in younger, active patients with hip disorders. Scores on the iHOT-12NL range between 0 and 100 (worst - best possible function). This questionnaire will be filled out by the patient during admission and at 6 weeks, 3, 6 and 12 months follow up.
Operation time: the operation time is recorded in the surgical report.
Baseline parameters: Additional parameters that will be recorded are: sex, date of birth, general health score (using the ASA classification), fracture type and side, trauma surgeon or orthopaedic trauma surgeon, type of anaesthesia, Body Mass Index. These parameters will be assessed during admission as a baseline measure.
Costs: Costs will be assessed from a societal perspective. Cost of (revision) surgery will be calculated using a bottom-up approach. Using a questionnaire the patients will report other health care use such as physiotherapy, rehabilitation care or nursing home care, visits to the general practitioners and medical specialists and medication, and non-medical care (domestic help and absenteeism). This questionnaire will be filled out by the patient at 6 weeks, 3, 6 and 12 months follow up. Health care use will be valued using Dutch reference prices [
23].
Health related quality of life: the EuroQol (EQ-5D-5 L) questionnaire measures five dimensions (mobility, self-care, daily activities, pain/discomfort, anxiety/depression), on a five-point scale (no, some, moderate, much or extreme problems). For each health state described by the patients, a utility score can be calculated that reflects society’s valuation of that health state [
24]. In addition, patients rate their overall health-related quality of life on a Visual Analogue scale (VAS). This questionnaire will be filled out by the patient during admission and at 6 weeks, 3, 6 and 12 months follow up. The utility scores obtained by the descriptive system and the VAS will be used in the cost-effectiveness analysis.