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

NCT04127045 | Completed

• 1 other identifier: 5559
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Intertrochanteric Fractures; Femur Fracture

Keywords

gait analysis; hip fracture; elderly; mobility

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Changes in ROM of Kinematic Angles

  12- months

• GGA-g Index

  12- months

• GGA-a Index

  12- months

Study Arms (2)

IMN-Group

Patients treated with intramedullary nailing

Procedure: IMN-Group

HA-Group

Patients treated with Hemiarthroplasty

Procedure: HA-Group

Interventions

IMN-Group PROCEDURE

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.

IMN-Group

HA-Group PROCEDURE

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).

HA-Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• neurological diseases
• musculoskeletal disorders
• cardiovascular diseases

Sponsors & Collaborators

• Biagio Moretti, MD: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, IT, 70124, Italy

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 33261299 RESULT

MeSH Terms

Conditions

Hip Fractures; Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Biagio Moretti, M.D.

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: October 2, 2017
• Primary Completion: October 2, 2018
• Study Completion: December 31, 2018
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

IT (1)