MobiChina - A Prospective Multicenter Cohort Study

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296086
• Other study ID #: MobiChina
• Status: Completed
• Start date: April 2015
• Est. completion date: November 2019

Study information

• Verified date: September 2019
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Unstable Fracture

Locations

Country	Name	City	State
China	DCN Hospital	Beijing
China	JiShuiTan Hopsital	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu
China	3th Hospital of Hebei Medical University of Hebei	Hebei	Hebei
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
Hong Kong	Queen Elisabeth Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong	Pokfulam

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Barthel Index	Investigator completed score	6 weeks postoperative
Secondary	Modified Barthel Index	Modified Barthel Index is retrospectively assessed for the pre-injury status using an investigator completed score	Baseline
Secondary	Modified Barthel Index	Investigator completed score	12 weeks postoperative
Secondary	Immobilization-related adverse events	Immobilization-related adverse events: Pneumonia; Lung embolism; Pressure sores/ulcers; Urinary tract infections	From surgery to 1 year follow-up
Secondary	Fixation failures	As assessed by the local investigator	From surgery up to 1 year follow-up
Secondary	Any other adverse events		From surgery up to 1 year follow-up
Secondary	Mortality		From surgery up to 1 year postoperative
Secondary	Muscle loss	Calf circumference measurement comparison: Loss calculated in %	From surgery up to 1 year follow-up
Secondary	Time to achieve partial and full weight bearing	Will be assessed during the patient interview	From surgery to 1 year follow-up
Secondary	Duration of hospital stay		For the duration of hospital stay, an expected average of 3 weeks
Secondary	Numbers of re-admissions to the hospital		From surgery to 1 year follow-up
Secondary	Quality of life: EuroQoL (EQ-5D)	Quality of life questionnaire using the EQ-5D	12 weeks postoperative
Secondary	Residential status	Will be assessed during the patient interview	Baseline to 1 year follow-up