MobiChina - A Prospective Multicenter Cohort Study

AO Innovation Translation Center

Status: Completed

Conditions: Hip Fracture; Unstable Fracture

Study type: Observational

Funder types: Other

Identifiers

NCT02296086

MobiChina

Details and patient eligibility

About

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

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

284 participants in 2 patient groups

Group I

Description:

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

Description:

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