ProspEctive Cohort Study on Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population

Completed

• Conditions: Hip Fractures; Intertrochanteric Fractures; Femur Fracture
• Interventions: Procedure: IMN-Group; Procedure: HA-Group

• Registration Number: NCT04127045
• Lead Sponsor: Biagio Moretti, MD

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-10-02
• Primary Completion: 2018-10-02
• Study Completion: 2018-12-31
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-12
• Study First Posted: 2019-10-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• neurological diseases
• musculoskeletal disorders
• cardiovascular diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IMN-Group	IMN-Group	Patients treated with intramedullary nailing
HA-Group	HA-Group	Patients treated with Hemiarthroplasty

Primary Outcome Measures

Name	Time	Method
Changes in T-Score at follow-up	12- months	T-score is the relevant measure when screening for osteoporosis extracted from Dual energy X-ray Absorptiometry (DXA). It is the bone mineral density (BMD) at the site when compared to the young normal reference mean. A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis. A T-score of -2.5 or lower indicates that you have osteoporosis. The greater the negative number, the more severe the osteoporosis.
Changes in HHS at follow-up	12- months	Harris Hip Score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.
Changes in Temporal Parameters of Gait at follow-up	12- months	Gait Analysis will be performed in two different time points and parameters related to temporal characteristics of gait during a gait cycle will be estimated (expressed in percentage): stance phase (%), swing phase (%)
Changes in WOMAC at follow-up	12- months	Western Ontario and Mc Master University Scale evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
Changes in Spatial Parameters of Gait at follow-up	12- months	Gait Analysis will be performed in two different time points and parameters related to spatial characteristics of gait during a gait cycle will be estimated: stride length (m), step length (m), step width (m).

Secondary Outcome Measures

Name	Time	Method
Changes in ROM of Kinematic Angles	12- months	Gait Analysis will be performed in two different time points and the changes in ankle, knee, hip and pelvis angles (all measured in degree) will be estimated.
GGA-g Index	12- months	Gait Analysis will be performed in two different time points and an overall index of asymmetry (Global Gait Asymmetry) during the gait cycle will be estimated. The higher the index, the higher the asymmetry between body part.
GGA-a Index	12- months	Gait Analysis will be performed in two different time points and an index of asymmetry (Global Gait Asymmetry) during the gait cycle in each kinematic angles (ankle, knee, hip and pelvis) will be estimated. The higher the index, the higher the asymmetry between body part.

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari; 🇮🇹 Bari, IT, Italy