MobiChina - A Prospective Multicenter Cohort Study

Study Overview
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Brief Summary
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The study will assess the difference in functionality between early vs. standard mobilization after hip fracture in the Chinese population.

Detailed Description
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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.

Official Title
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A Prospective Multicenter Cohort Study to Evaluate the Effect of Early Mobilization of Patients After Hip Fracture Fixation on Functional Outcomes in the Chinese Population

Conditions
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Unstable Fracture, Hip Fracture

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Study sites in which patients perform early mobilization as per local standard of care, which is as follows: 2 days (at the latest) after surgery: Transfer from the bed to a sitting chair for the first time 4 (± 2) days after surgery: Stand up and put both feet on the ground for the first time (walking aids allowed) 5 (± 2) days after surgery: Walking (at least partial weight bearing, walking aids allowed) The patients are instructed by the investigator at the hospital about a standardized mobilization program to be followed at home | |
| Group II<br>Study sites in which patients start walking (i.e. partial weight bearing, walking aids allowed) more than 7 days after surgery as per local standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Barthel Index | Investigator completed score | 6 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Barthel Index | Modified Barthel Index is retrospectively assessed for the pre-injury status using an investigator completed score | Baseline | 
| Modified Barthel Index | Investigator completed score | 12 weeks postoperative | 
| Immobilization-related adverse events | Immobilization-related adverse events: Pneumonia Lung embolism Pressure sores/ulcers Urinary tract infections | From surgery to 1 year follow-up | 
| Fixation failures | As assessed by the local investigator | From surgery up to 1 year follow-up | 
| Any other adverse events |  | From surgery up to 1 year follow-up | 
| Mortality |  | From surgery up to 1 year postoperative | 
| Muscle loss | Calf circumference measurement comparison: Loss calculated in % | From surgery up to 1 year follow-up | 
| Time to achieve partial and full weight bearing | Will be assessed during the patient interview | From surgery to 1 year follow-up | 
| 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) | Quality of life questionnaire using the EQ-5D | 12 weeks postoperative | 
| Residential status | Will be assessed during the patient interview | Baseline to 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geriatrics [MeSH], Hip fractures [MeSH], China [MeSH], Early ambulation [MeSH], Immobilization [MeSH]