Unstable FractureNCT02296086
MobiChina - A Prospective Multicenter Cohort Study
An observational study of Unstable Fracture and Hip Fracture, run by AO Innovation Translation Center at 11 sites in 2 countries.
Trial summary
The study will assess the difference in functionality between early vs. standard mobilization after hip fracture in the Chinese population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Unstable Fracture, Hip Fracture
- How many people
- 284 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Apr 2015to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
China9 sites
JiShuiTan Hopsital
Beijing, Beijing Municipality
DCN Hospital
Beijing
West China Hospital of Sichuan University
Chengdu
3th Hospital of Hebei Medical University of Hebei
Hebei, Hebei
Yunnan Second People Hospital
Kunming
Nantong University 1st Affiliated Hospital
Nantong
Shanghai Sixth People Hospital
Shanghai
The University of Hong Kong-Shenzhen Hospital
Shenzhen
Hong Hui Hospital
Xi'an
Hong Kong2 sites
Queen Mary Hospital
Hong Kong, Pokfulam
Queen Elisabeth Hospital
Hong Kong
About this 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
The study will assess the difference in functionality between early vs. standard mobilization after hip fracture in the Chinese population.
Read the 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.
- Conditions
- Unstable Fracture, Hip Fracture
- Keywords
- Geriatrics [MeSH], Hip fractures [MeSH], China [MeSH], Early ambulation [MeSH], Immobilization [MeSH]
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Modified Barthel Index
Investigator completed score
Measured: 6 weeks postoperative
Secondary outcomes (12)
Modified Barthel Index
Modified Barthel Index is retrospectively assessed for the pre-injury status using an investigator completed score
Measured: Baseline
Modified Barthel Index
Investigator completed score
Measured: 12 weeks postoperative
Immobilization-related adverse events
Immobilization-related adverse events:
- Pneumonia
- Lung embolism
- Pressure sores/ulcers
- Urinary tract infections
Measured: From surgery to 1 year follow-up
Fixation failures
As assessed by the local investigator
Measured: From surgery up to 1 year follow-up
Any other adverse events
Measured: From surgery up to 1 year follow-up
Mortality
Measured: From surgery up to 1 year postoperative
Muscle loss
Calf circumference measurement comparison: Loss calculated in %
Measured: From surgery up to 1 year follow-up
Time to achieve partial and full weight bearing
Will be assessed during the patient interview
Measured: From surgery to 1 year follow-up
Duration of hospital stay
Measured: For the duration of hospital stay, an expected average of 3 weeks
Numbers of re-admissions to the hospital
Measured: From surgery to 1 year follow-up
Quality of life: EuroQoL (EQ-5D)
Quality of life questionnaire using the EQ-5D
Measured: 12 weeks postoperative
Residential status
Will be assessed during the patient interview
Measured: Baseline to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frankie Leung, MD, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296086
- Sponsor's protocol ID
- MobiChina
- Status last verified
- Sep 2019
- First submitted
- 14 Nov 2014
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02296086
- Acronym / sponsor ID
- MobiChina
- Conditions
- Unstable Fracture, Hip Fracture
- Keywords
- Geriatrics [MeSH], Hip fractures [MeSH], China [MeSH], Early ambulation [MeSH], Immobilization [MeSH]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Barthel Index
Time frame: 6 weeks postoperative
Investigator completed score
12 secondary outcomes
Modified Barthel Index
Time frame: Baseline
Modified Barthel Index
Time frame: 12 weeks postoperative
Immobilization-related adverse events
Time frame: From surgery to 1 year follow-up
Fixation failures
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
Time frame: From surgery up to 1 year follow-up
Time to achieve partial and full weight bearing
Time frame: From surgery to 1 year follow-up
Duration of hospital stay
Time frame: For the duration of hospital stay, an expected average of 3 weeks
Numbers of re-admissions to the hospital
Time frame: From surgery to 1 year follow-up
Quality of life: EuroQoL (EQ-5D)
Time frame: 12 weeks postoperative
Residential status
Time frame: Baseline to 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frankie Leung, MD principal investigator
Queen Mary Hospital, Hong Kong
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unstable Fracture and Hip Fracture, run by AO Innovation Translation Center at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Barthel Index (time frame: 6 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.