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

NCT ID: NCT04127045

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2018-12-31

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.

Conditions

Hip Fractures; Intertrochanteric Fractures; Femur Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IMN-Group

Patients treated with intramedullary nailing

IMN-Group

Intervention Type: 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.

HA-Group

Patients treated with Hemiarthroplasty

HA-Group

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biagio Moretti, MD

OTHER

Sponsor Role: lead

Responsible Party

Biagio Moretti, MD

Full Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Biagio Moretti, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, IT, Italy

Countries

Italy

References

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.

Reference Type: 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.

Reference Type: RESULT

PMID: 33261299 (View on PubMed)

Other Identifiers

5559

Identifier Type: -

Identifier Source: org_study_id