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NCT Number: NCT05602155

Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture.

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.

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Key information

Conditions

Femur Intertrochanteric Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duran Topak

Kahramanmaraş, Eyalet/Yerleşke, 46040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1

Procedure

Even numbered patients will partial weight bearing after treatment,

Other names: partial weight bearing

Group 2

Procedure

patients with odd numbers will walk with full weight bearing after treatment

Other names: full weight bearing

Primary outcomes

  1. demographic datas

    Time frame: August 2018

    Descriptive statistical data

  2. comparison of groups

    Time frame: 1 year after surgery

    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.

  3. comparison of groups

    Time frame: 6 month after operative treatment

    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

  4. comparison of groups

    Time frame: At the beginning of the study

    age (year)

  5. comparison of groups

    Time frame: before surgery

    Vit D (microgram\\L)

  6. comparison of groups

    Time frame: august 2022

    Complication (cut out, Z effect, infection, implant failure)

  7. comparison of groups

    Time frame: On completion of the study, an average of 1 year

    Union time (week): Fracture union was defined radiologically as visible callus formation and reduction in pain in the groin.

  8. comparison of groups

    Time frame: patient's last control date, at least 1 year later

    Following time (month): The time elapsed between the date the patient came for the last control and the first application

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Acronym: randomized

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 1, 2022
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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