Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture.

NCT05602155 | Completed

• 1 other identifier: 13.07.2018\16
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femur Intertrochanteric Fractures

Keywords

intertrochanteric fracture; elderly fractures; weight bearing

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Group 1

weight bearing situation: patients with partial weight bearing after treatment

Procedure: Group 1; Procedure: Group 2

Group 2

weight bearing: patients with full weight bearing after treatment

Procedure: Group 1; Procedure: Group 2

Interventions

Group 1 PROCEDURE

Even numbered patients will partial weight bearing after treatment,

Also known as: partial weight bearing

Group 1; Group 2

Group 2 PROCEDURE

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

Also known as: full weight bearing

Group 1; Group 2

Eligibility Criteria

• Age: 65 Years - 95 Years
• Gender Eligibility Details: over 60 ages
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1\. Patients over 65 years of age who underwent proximal femoral nail due to femoral intertrochanteric fracture

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Duran Topak

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

Location

Related Publications (2)

• Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.

  PMID: 10853723 RESULT

• Jensen JS. Classification of trochanteric fractures. Acta Orthop Scand. 1980 Oct;51(5):803-10. doi: 10.3109/17453678008990877.

  PMID: 7468173 RESULT

Related Links

• Barthel index
• Fracture classification

MeSH Terms

Conditions

Hip Fractures

Interventions

Partial Weight-Bearing

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Weight-Bearing; Mechanical Phenomena; Physical Phenomena

Study Officials

• Ökkeş Bilal, 3.

  Assistant researcher

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Clinical Assoc. Prof.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: November 1, 2022
• Study Start: August 1, 2018
• Primary Completion: March 30, 2021
• Study Completion: August 30, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years
• Access Criteria: for researchers

Locations

TU (1)