NCT02296086

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 284 (actual)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unstable Fracture
• Hip Fracture

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2014-11-20
• Last updated: 2020-06-04

Locations

11 sites across 2 countries: China, Hong Kong