Hip Fractures Clinical Trial
— EFFRA-65Official title:
ProspEctive Cohort Study on Integrated and Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
NCT number | NCT04127045 |
Other study ID # | 5559 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2, 2017 |
Est. completion date | December 31, 2018 |
Verified date | September 2021 |
Source | University of Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 31, 2018 |
Est. primary completion date | October 2, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - age older than 65 years - previous walking ability - surgical procedure (intramedullary nailing or hemiarthroplasty) Exclusion Criteria: - neurological diseases - musculoskeletal disorders - cardiovascular diseases |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari | IT |
Lead Sponsor | Collaborator |
---|---|
Biagio Moretti, MD |
Italy,
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 R — View 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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