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The study will assess the difference in functionality between early vs. standard mobilization after hip fracture in the Chinese population.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Study sites in which patients perform early mobilization as per local standard of care, which is as follows:
| ||
| Group II | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Modified Barthel Index | Investigator completed score | 6 weeks postoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Frankie Leung, MD | Queen Mary Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JiShuiTan Hopsital | Beijing | Beijing Municipality | China | |||
| 3th Hospital of Hebei Medical University of Hebei |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| 12 weeks postoperative |
| Immobilization-related adverse events | Immobilization-related adverse events:
| 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 |
| Hebei |
| Hebei |
| China |
| DCN Hospital | Beijing | China |
| West China Hospital of Sichuan University | Chengdu | China |
| Yunnan Second People Hospital | Kunming | China |
| Nantong University 1st Affiliated Hospital | Nantong | China |
| Shanghai Sixth People Hospital | Shanghai | China |
| The University of Hong Kong-Shenzhen Hospital | Shenzhen | China |
| Hong Hui Hospital | Xi'an | China |
| Queen Mary Hospital | Hong Kong | Pokfulam | Hong Kong |
| Queen Elisabeth Hospital | Hong Kong | Hong Kong |
| D007869 |
| Leg Injuries |