Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture.

NCT ID: NCT05602155

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2022-08-30

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.

Conditions

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Femur Intertrochanteric Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

weight bearing situation: patients with partial weight bearing after treatment

Group 1

Intervention Type PROCEDURE

Even numbered patients will partial weight bearing after treatment,

Group 2

Intervention Type PROCEDURE

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

Group 2

weight bearing: patients with full weight bearing after treatment

Group 1

Intervention Type PROCEDURE

Even numbered patients will partial weight bearing after treatment,

Group 2

Intervention Type PROCEDURE

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

Interventions

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Group 1

Even numbered patients will partial weight bearing after treatment,

Intervention Type PROCEDURE

Group 2

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

Intervention Type PROCEDURE

Other Intervention Names

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partial weight bearing full weight bearing

Eligibility Criteria

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Inclusion Criteria

1. Patients over 65 years of age with intertrochanteric femoral fractures
2. Patients treated with proximal femoral nail
3. Patients able to walk before treatment
4. Patients who can be contacted

Exclusion Criteria

1. Patients without regular follow-up for 1 year
2. Patients who do not walk before or after fracture
3. who have a neurological disease
4. Patients with partial hip replacement after fracture
5. Patients who cannot be contacted after treatment
6. Patients who died within 1 year after treatment
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Duran Topak

Orthopaedic Clinical Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ökkeş Bilal, 3.

Role: STUDY_CHAIR

Assistant researcher

Locations

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Duran Topak

Kahramanmaraş, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 10853723 (View on PubMed)

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

Reference Type RESULT
PMID: 7468173 (View on PubMed)

Related Links

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Other Identifiers

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13.07.2018\16

Identifier Type: -

Identifier Source: org_study_id

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