Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture.

Completed

• Conditions: Femur Intertrochanteric Fractures
• Interventions: Procedure: Group 1; Procedure: Group 2

• Registration Number: NCT05602155
• Lead Sponsor: Kahramanmaras Sutcu Imam University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2021-03-30
• Study Completion: 2022-08-30
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-28
• Status Verified: 2022-11
• Study First Posted: 2022-11-01
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Group 2	weight bearing situation: patients with partial weight bearing after treatment
Group 2	Group 1	weight bearing: patients with full weight bearing after treatment
Group 2	Group 2	weight bearing: patients with full weight bearing after treatment
Group 1	Group 1	weight bearing situation: patients with partial weight bearing after treatment

Primary Outcome Measures

Name	Time	Method
demographic datas	August 2018	Descriptive statistical data
comparison of groups	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

Trial Locations

Locations (1)

Duran Topak; 🇹🇷 Kahramanmaraş, Eyalet/Yerleşke, Turkey