Hip Fracture and Muscle Resilience
HIPRESM
Mucle Resilience: Muscular Markers Predictive of Functional Recovery After Femoral Neck Fracture in Orthogeriatrics
2 other identifiers
observational
67
1 country
4
Brief Summary
The aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy. The fracture of the upper end of the femur (EFSF) is a pathology:
- Frequent, affecting the elderly: in France, 80,000 patients / year, 83% aged ≥ 75 years (DREES, 2011),
- severe, on mortality and autonomy: 40% will not recover their walking capacity earlier than 6 months, 13% of patients \> 85 years old walk unaided at 4 months and 11% of patients will be newly admitted to an institution in 6 months after the fracture (UPOG / PSL data).
- and costly: costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million for health insurance in France. Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond / recover from acute stress related to the EFSF. Physical resilience is an emerging concept in medicine that defines the dynamic ability of a subject to resist or recover from functional decline as a result of stress or disruption. In this context, developing new approaches to assessing resilience is important, to take into account this resilience specific to each patient in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to be able to identify, in elderly patients after an EFSF intervention, the muscular signature associated with good functional recovery (= physical resilience). The goal of the investigators is to develop software that will provide this muscle signature by measuring and analyzing parameters from high-definition surface electromyography (HD-sEMG). This technology is innovative, non-invasive and portable, CE marked but not yet used in clinical routine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2020
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedStudy Start
First participant enrolled
February 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2023
CompletedNovember 22, 2023
November 1, 2023
3.4 years
October 25, 2019
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HD-sEMG correlated to SPPB
Identify HD-sEMG parameters and mesured them during quadriceps muscle extension on lower limb not affected by surgery in the 7th days after UFF surgery, associated to functional status without human assistance (SPPB) at Day 30.
Day 30
Secondary Outcomes (8)
Walking ability at Day 30
Day 30
Patient autonomy at Day 30
Day 30
5 meters Walking speed at Day 30
Day 30
Quality of life at Day 30: European Quality of Life-5 Dimensions questionnaire
Day 30
HD-sEMG parameters at Day 30
Day 30
- +3 more secondary outcomes
Interventions
HD-sEMG data will be collected by Mobita 32® (TMSi) device
Eligibility Criteria
Older patients aged 70 years old and over, hospitalized in orthogeriatics after upper femoral fracture surgery.
You may qualify if:
- Patient ≥ 70 years old
- Managed by orthogeriatric unit after upper femoral fracture surgery
- Patient informed of the study and who has not objected to his participation.
You may not qualify if:
- Patient bedridden before the femoral fracture, with limited autonomy to bed-chair transfers
- Any other associated fracture
- Cutaneous allergy with adhesive plaster
- BMI ≥ 30 kg / m²
- Cognitive disorders preventing the correct execution of the movement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
APHP - Charles Foix Hospital
Ivry-sur-Seine, 94200, France
APHP - Rotschild
Paris, Île-de-France Region, 75012, France
APHP - Saint-Antoine Hospital
Paris, Île-de-France Region, 75012, France
APHP - Pitie Salpetriere Hospital - UPOG
Paris, Île-de-France Region, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KIYOKA KINUGAWA, MD, PhD
APHP
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2019
First Posted
November 18, 2019
Study Start
February 21, 2020
Primary Completion
July 28, 2023
Study Completion
August 28, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.