Clinical trial NCT05602155: Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture.
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Intertrochanteric Fractures
Keywords: intertrochanteric fracture
elderly fractures
weight bearing
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 133
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients over 65 years of age who underwent proximal femoral nail due to femoral intertrochanteric fracture

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.

Eligibility criteria: 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

Primary outcomes:
measure: demographic datas
timeFrame: August 2018
measure: comparison of groups
timeFrame: 1 year after surgery
measure: comparison of groups
timeFrame: 6 month after operative treatment
measure: comparison of groups
timeFrame: At the beginning of the study
measure: comparison of groups
timeFrame: before surgery
measure: comparison of groups
timeFrame: august 2022
measure: comparison of groups
timeFrame: On completion of the study, an average of 1 year
measure: comparison of groups
timeFrame: patient's last control date, at least 1 year later
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Duran Topak
state: Eyalet/Yerleşke
Study officials:
affiliation: Assistant researcher
name: Ökkeş Bilal, 3.
role: STUDY_CHAIR
References:
citation: 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.
citation: Jensen JS. Classification of trochanteric fractures. Acta Orthop Scand. 1980 Oct;51(5):803-10. doi: 10.3109/17453678008990877.