MobiChina - A Prospective Multicenter Cohort Study

AO Innovation Translation Center284 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

284

Conditions

Unstable Fracture Hip Fracture

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (11)

JiShuiTan Hopsital

Beijing, Beijing Municipality, China

3th Hospital of Hebei Medical University of Hebei

Hebei, Hebei, China

DCN Hospital

Beijing, China

West China Hospital of Sichuan University

Outcomes

Primary Outcomes

Modified Barthel Index

Investigator completed score

Time frame: 6 weeks postoperative

Secondary Outcomes

Modified Barthel Index

Modified Barthel Index is retrospectively assessed for the pre-injury status using an investigator completed score

Time frame: Baseline

Modified Barthel Index

Investigator completed score

Time frame: 12 weeks postoperative

Immobilization-related adverse events

Immobilization-related adverse events: * Pneumonia * Lung embolism * Pressure sores/ulcers * Urinary tract infections

Time frame: From surgery to 1 year follow-up

Fixation failures

As assessed by the local investigator

Time frame: From surgery up to 1 year follow-up

Any other adverse events

Time frame: From surgery up to 1 year follow-up

Mortality

Time frame: From surgery up to 1 year postoperative

Muscle loss

Calf circumference measurement comparison: Loss calculated in %

Time frame: From surgery up to 1 year follow-up

Time to achieve partial and full weight bearing

Will be assessed during the patient interview

Data from ClinicalTrials.gov

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