Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture.

Study Overview
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Brief Summary
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Femur intertrochanteric fractures (FITC) are one of the most common fractures of the lower extremity, caused by osteoporosis, caused by minor trauma in elderly patients. Today, it is successfully treated with proximal femoral nails (PFN) designed in different ways. After surgical fixation with PFN, patients are mobilized by placing full weight, but some complications can be seen due to the patients being osteoporotic. In this study, the investigators planned to investigate the effect of full weight bearing and partial weight bearing on complications, which were not previously described in the literature.

Detailed Description
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Participants over the age of 60 who underwent PFN with the diagnosis of FITK were randomized (double-blinded consecutive full load on one patient and partial weight on one patient), and mobilized a group with full weight with the help of a walker after surgical fixation, and the other group with the help of a walker to give partial weight (balance). We planned to follow up his treatment prospectively. The compatibility of the groups will be evaluated by comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D levels and ages of the patients. Fracture types and post-treatment reduction quality of patients in both groups will be compared. We planned to compare the complication rates, Barthel Index and harris hip scores in the follow-up of the patients.

Official Title
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Comparison of Full-Weight and Partial-Weight-Bearing Patient Groups in Patients Over 65 Years of Age Who Underwent Proximal Femoral Nail Due to Intertrochanteric Fracture of the Femur

Conditions
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Femur Intertrochanteric Fractures

Intervention / Treatment
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* Procedure: Group 1
* Procedure: Group 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 65 years of age with intertrochanteric femoral fractures Patients treated with proximal femoral nail Patients able to walk before treatment Patients who can be contacted Exclusion Criteria: Patients without regular follow-up for 1 year Patients who do not walk before or after fracture who have a neurological disease Patients with partial hip replacement after fracture Patients who cannot be contacted after treatment Patients who died within 1 year after treatment

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>weight bearing situation: patients with partial weight bearing after treatment | Procedure: Group 1<br>* Even numbered patients will partial weight bearing after treatment,<br>* Other names: partial weight bearing;Procedure: Group 2<br>* patients with odd numbers will walk with full weight bearing after treatment<br>* Other names: full weight bearing;|
| Group 2<br>weight bearing: patients with full weight bearing after treatment | Procedure: Group 1<br>* Even numbered patients will partial weight bearing after treatment,<br>* Other names: partial weight bearing;Procedure: Group 2<br>* patients with odd numbers will walk with full weight bearing after treatment<br>* Other names: full weight bearing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demographic datas | Descriptive statistical data | August 2018 | 
| comparison of groups | harris hip score: The Turkish version of the Harris hip score with adequate internal consistency (Cronbach's alpha, 0.70) and test-retest reliability (ICC = 0.91) was used for functional outcomes. It is evaluated with scores ranging from 0 to 100. The higher the score, the better the hip function. | 1 year after surgery | 
| comparison of groups | Barthel Index: The Turkish version of the Barthel index, which was developed by Mahoney and Barthel in 1965, and edited by Küçükdeveci et al., was used to evaluate the degree of independence of patients in activities of daily living. In this scale, where the possible score is between 0-100, the high score means that the patient is independent from other people and can run his own business; 0-20 points are defined as fully dependent, 21-61 points severely dependent, 62-90 points moderately dependent, 91-99 points mildly dependent, and 100 points fully independent | 6 month after operative treatment | 
| comparison of groups | age (year) | At the beginning of the study | 
| comparison of groups | Vit D (microgram\L) | before surgery | 
| comparison of groups | Complication (cut out, Z effect, infection, implant failure) | august 2022 | 
| comparison of groups | Union time (week): Fracture union was defined radiologically as visible callus formation and reduction in pain in the groin. | On completion of the study, an average of 1 year | 
| comparison of groups | Following time (month): The time elapsed between the date the patient came for the last control and the first application | patient's last control date, at least 1 year later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intertrochanteric fracture, elderly fractures, weight bearing