Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-120
SponsorHelse Stavanger HF
About this trial
A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Today FTFs are mainly treated with internal fixation using sliding hips screws (SHS) or intramedullary nail (IMN), whilst hip arthroplasty (THA/HA) is rarely used. Despite advances in the design of the internal fixation implants there is a high failure rate, in particular in cases of FTFs classified as unstable fractures. Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates, early mobilization and shorter hospital stays.
The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility, give a better general health outcome for the patient, better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65 years
American Society of Anesthesiology Score (ASA) < 4
Ambulant with or without aid (preinjury)
Radiological verified unstable trochanteric hip fracture (AO 31A2.2 - 3.3)
Disqualifiers
Previous hip surgery on ipsilateral or contralateral side
Non-ambulant preinjury
Patient not living in the area of hospital care
Trial design
Design model
Parallel
Treatments tested in this trial
Intramedullary nail
Procedure/SurgeryIntertan nail (Smith \& Nephew)\* or Gamma 3 nail (Stryker)\* \* All of the above-mentioned products are subjects to change into an equivalent product
Hip arthroplasty
Procedure/SurgeryTotal hip arthroplasty: * Cemented: Lubinus (Link)\*, Exeter (Stryker)\* * Uncemented: Restoration Modular (Stryker)\* * Cup: Cemented Avantage dual mobility cup (Zimmer Biomet)\* Hemiarthroplasty: * Cemented: Lubinus (Link)\*, Exeter (Stryker)\* * Uncemented: Restoration Modular (Stryker)\* * All of the above-mentioned products are subjects to change into an equivalent product
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Intramedullary nailActive comparator 1 intervention
Group B: Hip arthroplastyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Reported Outcome Measure (PROM)
Hip disability and Osteoarthritis Outcome Score (HOOS). "HOOS is developed as an instrument to assess the patients' opinion about their hip and associated problems. HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile. * Above information about HOOS is copied from the authors of www.KOOS.nu * Change in HOOS score will be observed from 2-, 6- and 12 months.
Time frame
Collected at 2, 6 and 12 months from primary surgery2
Patient Reported Outcome Measure (PROM)
EuroQol EQ-5D. "The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement." Change in EQ-5D score will be observed from 2-, 6- and 12 months.
Time frame
Collected from 2 to 12 months from primary surgerySecondary outcomes
1
Mortality
Mortality rates will be analyzed
Time frame
2, 6 and 12 months from primary surgery2
Complications related to prosthesis
Specific complications related to the randomly assign intervention; * Peri prosthesis fracture * Prosthesis dislocation * Prosthesis loosening * Dislocation of trochanter major * Surgical wound infection (superficial) * Deep surgical wound infection
Time frame
Collected from 2 to 12 months from primary surgery3
Complications related to osteosynthesis
Specific complications related to the randomly assign intervention; * Peri implant fracture (intraoperative or postoperative) * Implant cut-out * Non-union of fracture * Dislocation of trochanter major * Surgical wound infection (superficial) * Deep surgical wound infection
Time frame
Collected from 2 to 12 months from primary surgery4
Somatic postoperative complications
* Deep vein thrombosis or other thromboembolic event * Pressure sores * Neurological complications * Other
Time frame
Collected from 2 to 12 months from primary surgerySponsors and contacts
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Source ClinicalTrials.gov