Hip Fractures
Conditions
Keywords
Surgical approach, Hemiarthroplasty
Brief summary
Patients with dislocated hip fractures are randomised to cemented hemiarthroplasty with an anterolateral approach or a direct lateral approach.
Detailed description
Dislocated intracapsular hip fractures are usually treated with cemented hemiarthroplasty. In Norway, a direct lateral approach is most often used, as recommended in national guidelines. In total hip arthroplasty, however, minimally invasive approaches are also commonly used, and may improve the clinical results, as compared to posterior or direct lateral approaches. The aims of the present study are to evaluate the effect of the minimally invasive anterolateral approach (Watson-Jones approach) compared to the direct lateral approach (Hardinge approach) to the hip joint in hemiarthroplasty after dislocated hip fractures. Patients with dislocated hip fractures who are fit for cemented hemiarthroplasty are randomised to surgery with an anterolateral approach or a direct lateral approach.
Interventions
PROCEDUREAnterolateral approach
Cemented hemiarthroplasty using an anterolateral approach.
PROCEDUREDirect lateral approach
Cemented hemiarthroplasty using a direct lateral approach.
Sponsors
Sykehuset Innlandet HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessors are instructed to assess the outcomes before they log in to the patients' journal. Thereby, they will not have information of the treatment allocation at the time of outcomes assessment. Also, they will not ask the patients to undress or in any other way examine the surgical site, as the location of the scar tissue may disclose the treatment allocation.
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* dislocated hip fracture. * planned cemented hemiarthroplasty. * able to walk, with or without walking aids, prior to the injury.
Exclusion criteria
* young and healthy patients with displaced hip fractures who are recommended total hip arthroplasty or open reduction / internal fixation of the fracture. * patients with severe comorbidity and high risk of cement-related complications who are recommended uncemented hemiarthroplasty (some, but not all, patients with ASA (American Society of Anesthesiologists) grade 4). * not able to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | 12 months | Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported limping | 12 months | Patient-reported limping is a sub-score of the Harris Hip Score. The patients describe their limping as (1) none, (2) slight, (3) moderate or (4) severe or unable to walk. |
| Patient-reported use of walking aid | 12 months | Patient-reported use of walking aid is a sub-score of the Harris Hip Score. The patients describe their use of walking aid as (1) none, (2) cane/walking stick for long walks, (3) cane/walking stick most of the time, (4) one crutch, (5) two canes/walking sticks or (6) two crutches or unable to walk. |
| Trendelenburg test | 12 months | Trendelenburg test is a clinical test for the integrity of hip abductor muscle function. The test is positive when the patient is unable to maintain the pelvis horizontal to the floor when standing on one leg. |
| Timed Up and Go (TUG) | 12 months | The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults. The patients start in a seated position, walk 3 meters, turn around, walk back to the chair and sit down. The time starts when the patient is commanded to start and stops when the patient is seated. |
| Blood loss | During surgery | The peroperative amount of blood loss (milliliters) is registered |
| EuroQol questionnaire (EQ-5D) | 12 months | Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers (no problems, some problems, and major problems). EQ-5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Length of hospital stay | 12 months | The length of hospital stay (days) is registered |
| Adverse events | 12 months | Adverse events such as perioperative complications, infections, dislocations and reoperations are registered |
| Mortality | 12 months | In patients who die within 12 months follow-up, the time of death is registered |
| Cause of death | 12 months | In patients who die within 12 months follow-up, the cause of death is registered |
| Duration of surgery | During surgery | The duration of the surgical procedure (minutes) is registered |
Countries
Norway
Outcome results
None listed