ProspEctive Cohort Study on Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population (EFFRA-65)

Biagio Moretti, MD

Status: Completed

Conditions: Hip Fractures; Femur Fracture; Intertrochanteric Fractures

Treatments: Procedure: IMN-Group; Procedure: HA-Group

Study type: Observational

Funder types: Other

Identifiers

NCT04127045

5559

Details and patient eligibility

About

Hip fractures are an increasing public health concern as the population continues to age. The increased morbidity and mortality in the 12-month period after hip fracture is largely related to decreased mobility. However, very few studies have analyzed the radiographic factors associated with gait impairment after intertrochanteric hip fractures. This study evaluates gait and mobility after surgical fixation of IT fractures in elderly population with Gait Analysis in combination with clinical and radiographic information.

Full description

Hip fractures are an increasing public health concern as the population continues to age. The increased morbidity and mortality in the 12-month period after hip fracture is largely related to decreased mobility. However, very few studies have analyzed the radiographic factors associated with gait impairment after InterTrochanteric (IT) hip fractures. Improving gait and mobility after surgical fixation of IT fractures is one important target of research efforts.

All the patients with IT hip fractures (AO/OTA 31) treated between October 2017 and April 2018 were enrolled. Inclusion criteria consisted of age older than 65 years, previous walking ability, no neurological disease and no other musculoskeletal disorders. The study was approved by the institutional review board of the Local Ethical Committee (reference number 5559). All patients provided written informed consent for participation in the study.

All patients were treated with intramedullary nailing (IMN) or hemiarthroplasty (HA) according to the current international guidelines and to their clinical history.

Radiographs were analyzed at the time of surgery and at each follow-up visit. Clinical outcomes were assessed according to the Harris Hip Score (HHS) and Western Ontario and Mc Master University (WOMAC).

At 6- and 12-months follow-up appointments, gait parameters were measured and recorded in our Gait Analysis Laboratory (BTS Bioengineering SpA, Italy) located in AOUC Policlinico di Bari (Rehabilitation Unit). All participants performed several walking trials at their natural speed. All patients were fitted with full-body external reflective markers placed according to Davis' procedures. A static video trial was recorded with subjects positioned in a neutral standing posture to create a reference for defining neutral joint angles.

In addition, at 12-months follow-up, dual energy X-ray absorptiometry (DXA) has been acquired in order to collect T-score data.

Statistical analyses were performed using IBM SPSS version 23. A p value of <0.05 was considered to be statistically significant.

Enrollment: 20 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age older than 65 years
• previous walking ability
• surgical procedure (intramedullary nailing or hemiarthroplasty)

Exclusion criteria

• neurological diseases
• musculoskeletal disorders
• cardiovascular diseases

Trial design

20 participants in 2 patient groups

IMN-Group

Description:

Patients treated with intramedullary nailing

Treatment:

Procedure: IMN-Group

HA-Group

Description:

Patients treated with Hemiarthroplasty

Treatment:

Procedure: HA-Group