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

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Femur Fracture; Intertrochanteric Fractures
• Intervention / Treatment: Procedure: IMN-Group; Procedure: HA-Group

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • IT
    • Bari, IT, Italy, 70124
      • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the patients with IT hip fractures (AO/OTA 31) treated between October 2017 and April 2018 in the Orthopedic and Trauma Unit of AOUC Policlinico di Bari were enrolled.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IMN-Group; Patients treated with intramedullary nailing	Procedure: IMN-Group; Most intertrochanteric fractures are managed with an intramedullary nail, which allows for impaction at the fracture site. The intramedullary nail is placed directly into the marrow canal of the bone through an opening made at the top of the greater trochanter. A lag screw is then placed through the nail and up into the neck and head of the hip. As with the compression hip screw, sliding of the lag screw and impaction of the fracture take place.
HA-Group; Patients treated with Hemiarthroplasty	Procedure: HA-Group; In the older patient, the chance that the head of the femur is damaged in this way is higher. It is generally felt that for these displaced fractures, patients will do better if some of the components of the hip are replaced. In some cases, this can mean a replacement of the ball, or head of the femur (hemiarthroplasty).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HHS at follow-up	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.	12- months
Changes in WOMAC at follow-up	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.	12- months
Changes in T-Score at follow-up	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.	12- months
Changes in Spatial Parameters of Gait at follow-up	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).	12- months
Changes in Temporal Parameters of Gait at follow-up	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 (%)	12- months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ROM of Kinematic Angles	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.	12- months
GGA-g Index	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.	12- months
GGA-a Index	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.	12- months

Collaborators and Investigators

• Sponsor: Biagio Moretti, MD
• Investigators: Principal Investigator: Biagio Moretti, M.D., University of Bari

Publications and helpful links

General Publications

• Bortone, I., Caringella, N., Lelli, G., Rifino, F., Di Candia, A., Fiore, P., & Moretti, B. (2018). Effective mobility recovery after femoral neck fractures: The necessity of gait analysis in the immediate post-operative aftercare. Gait & Posture, 66, S7.
• Bizzoca D, Bortone I, Vicenti G, Caringella N, Rifino F, Moretti B. Gait analysis in the postoperative assessment of intertrochanteric femur fractures. J Biol Regul Homeost Agents. 2020 Jul-Aug;34(4 Suppl. 3):345-351. Congress of the Italian Orthopaedic Research Society.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2017
• Primary Completion (ACTUAL): October 2, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 12, 2019
• First Posted (ACTUAL): October 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: elderly; mobility; hip fracture; gait analysis
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 5559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No