Clinical trial NCT02296086: MobiChina - A Prospective Multicenter Cohort Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unstable Fracture
Hip Fracture
Keywords: Geriatrics [MeSH]
Hip fractures [MeSH]
China [MeSH]
Early ambulation [MeSH]
Immobilization [MeSH]
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 284
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Barthel Index
timeFrame: 6 weeks postoperative
Secondary outcomes:
measure: Modified Barthel Index
timeFrame: Baseline
measure: Modified Barthel Index
timeFrame: 12 weeks postoperative
measure: Immobilization-related adverse events
timeFrame: From surgery to 1 year follow-up
measure: Fixation failures
timeFrame: From surgery up to 1 year follow-up
measure: Any other adverse events
timeFrame: From surgery up to 1 year follow-up
measure: Mortality
timeFrame: From surgery up to 1 year postoperative
measure: Muscle loss
timeFrame: From surgery up to 1 year follow-up
measure: Time to achieve partial and full weight bearing
timeFrame: From surgery to 1 year follow-up
measure: Duration of hospital stay
timeFrame: For the duration of hospital stay, an expected average of 3 weeks
measure: Numbers of re-admissions to the hospital
timeFrame: From surgery to 1 year follow-up
measure: Quality of life: EuroQoL (EQ-5D)
timeFrame: 12 weeks postoperative
measure: Residential status
timeFrame: Baseline to 1 year follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: JiShuiTan Hopsital
state: Beijing
city: Hebei
country: China
facility: 3th Hospital of Hebei Medical University of Hebei
state: Hebei
city: Beijing
country: China
facility: DCN Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Kunming
country: China
facility: Yunnan Second People Hospital
city: Nantong
country: China
facility: Nantong University 1st Affiliated Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People Hospital
city: Shenzhen
country: China
facility: The University of Hong Kong-Shenzhen Hospital
city: Xi'an
country: China
facility: Hong Hui Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
state: Pokfulam
city: Hong Kong
country: Hong Kong
facility: Queen Elisabeth Hospital
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Frankie Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: