MobiChina - A Prospective Multicenter Cohort Study

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

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

Study Overview

• Status: Completed
• Conditions: Hip Fracture; Unstable Fracture

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.

• Study Type: Observational
• Enrollment (Actual): 284

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • DCN Hospital
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Kunming, China
    • Yunnan Second People Hospital
  • Nantong, China
    • Nantong University 1st Affiliated Hospital
  • Shanghai, China
    • Shanghai Sixth People Hospital
  • Shenzhen, China
    • The University of Hong Kong-Shenzhen Hospital
  • Xi'an, China
    • Hong Hui Hospital
  • Beijing
    • Beijing, Beijing, China
      • JiShuiTan Hopsital
  • Hebei
    • Hebei, Hebei, China
      • 3th Hospital of Hebei Medical University of Hebei
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Elisabeth Hospital
  • Pokfulam
    • Hong Kong, Pokfulam, Hong Kong
      • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group I; 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; 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?

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

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Frankie Leung, MD, Queen Mary Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Geriatrics [MeSH]; Hip fractures [MeSH]; China [MeSH]; Early ambulation [MeSH]; Immobilization [MeSH]
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: MobiChina