Hip Fracture, Unstable Fracture
Conditions
Keywords
Geriatrics [MeSH], Hip fractures [MeSH], China [MeSH], Early ambulation [MeSH], Immobilization [MeSH]
Brief summary
The study will assess the difference in functionality between early vs. standard mobilization after hip fracture in the Chinese population.
Detailed description
The primary objective of this prospective observational cohort study is to assess the difference in functionality between Group I and II (see mobilization regimens for the two groups above) at 6 weeks using the modified Barthel Index in the Chinese population. The allocation of patients to the two groups will be performed on a clinic level: 50% of patients will be recruited by study sites in Group I (early mobilization). The other 50% of patients will be recruited by study sites in Group II. The sites are carefully selected after evaluating their standard procedures of mobilizing elderly patients after hip fractures. This process is documented using formal site selection questionnaires. The modified Barthel Index is estimated at 75 points for Group II and at 85 points for Group I. Patients aged 65 years and older with unstable intertrochanteric fractures (AO 31 A2 or A3) treated with an intramedullary nail will be included in this study. The study visits will be defined as preoperative, surgery, discharge, 6 (± 2) weeks and 12 (± 2) weeks follow-up (FU) visits. Furthermore, there will be a telephone contact 12 months (± 1 month) postsurgery.
Interventions
None listed
Sponsors
AO Innovation Translation Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 and older * Diagnosis of an unstable intertrochanteric fractures (AO 31- A2 or A3) treated with an intramedullary nail * Ability to walk independently or with a walking aid prior to injury * Informed consent obtained, i.e.: Ability of the patient to understand the content of the patient information / Informed Consent Form and signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent
Exclusion criteria
* Severe dementia * Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Barthel Index | 6 weeks postoperative | Investigator completed score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immobilization-related adverse events | From surgery to 1 year follow-up | Immobilization-related adverse events: * Pneumonia * Lung embolism * Pressure sores/ulcers * Urinary tract infections |
| Fixation failures | From surgery up to 1 year follow-up | As assessed by the local investigator |
| Any other adverse events | From surgery up to 1 year follow-up | — |
| Mortality | From surgery up to 1 year postoperative | — |
| Muscle loss | From surgery up to 1 year follow-up | Calf circumference measurement comparison: Loss calculated in % |
| Modified Barthel Index | Baseline | Modified Barthel Index is retrospectively assessed for the pre-injury status using an investigator completed score |
| Duration of hospital stay | For the duration of hospital stay, an expected average of 3 weeks | — |
| Numbers of re-admissions to the hospital | From surgery to 1 year follow-up | — |
| Quality of life: EuroQoL (EQ-5D) | 12 weeks postoperative | Quality of life questionnaire using the EQ-5D |
| Residential status | Baseline to 1 year follow-up | Will be assessed during the patient interview |
| Time to achieve partial and full weight bearing | From surgery to 1 year follow-up | Will be assessed during the patient interview |
Countries
China, Hong Kong
Outcome results
None listed