Clinical trial NCT04127045: ProspEctive Cohort Study on Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
Official title: ProspEctive Cohort Study on Integrated and Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Intertrochanteric Fractures
Femur Fracture
Keywords: gait analysis
hip fracture
elderly
mobility
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* neurological diseases
* musculoskeletal disorders
* cardiovascular diseases

Primary outcomes:
measure: Changes in HHS at follow-up
timeFrame: 12- months
measure: Changes in WOMAC at follow-up
timeFrame: 12- months
measure: Changes in T-Score at follow-up
timeFrame: 12- months
measure: Changes in Spatial Parameters of Gait at follow-up
timeFrame: 12- months
measure: Changes in Temporal Parameters of Gait at follow-up
timeFrame: 12- months
Secondary outcomes:
measure: Changes in ROM of Kinematic Angles
timeFrame: 12- months
measure: GGA-g Index
timeFrame: 12- months
measure: GGA-a Index
timeFrame: 12- months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
state: IT
Study officials:
affiliation: University of Bari
name: Biagio Moretti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.