Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients; a 5-year Follow up Study

Femoral Neck Fractures Clinical Trial

Official title:

Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients: a 5-year Follow up Study Addressing the Influence of Surgical Approach on Periprosthetic Bone Mineral Density.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753100
• Other study ID #: Stein Ugland
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: March 25, 2020

Study information

• Verified date: November 2018
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study addressing the influence of surgical approach on periprosthetic bone mineral density.

Description:

Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468).Patients between 70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and the ability to walk with or without a walking aid prior to falling were asked for their agreement to be enrolled and partition occurred after informed consent.A subgroup analysis looking at periprosthetic bone mineral density around the femoral component was part of this level 1 single-center randomized trial. 51 patients were enrolled in this DEXA study, and future examination of bone remodeling in these patients is now planned.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients between 70 and 90 years of age with displaced femoral neck fractures

• Intact cognitive function

• Ability to walk with or without a walking aid prior to falling.

Exclusion Criteria:

• Dementia

• Fractures in pathologic bone

• Patients not belonging to the hospital community

• Patients with sepsis or local infection

• Fracture not eligible to be treated with a hemiarthroplasty

Related Conditions & MeSH terms

• Bone Mineral Density
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Other:
• Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint
The measurement will start in the area about 2 cm proximal to the greater trochanter and will stop slightly below the tip of the prosthesis. This is the baseline scan and will be carried out twice with the patient lying on the table, but with movement between each scan. This is done to calculate the CV, Coefficient of Variation. We will use the formula from Wilkinson and associates, where delta is standard deviations (SD) of the difference between the two BMD measurements for each patient. BMD has been measured at baseline, 3 and 12 months. A DXA scan is now planned at 60 months. Changes in BMD related to the 7 Gruen zones will be registered.

Locations

Country	Name	City	State
Norway	Departement of Orthopaedics, Sorlandet Hospital	Kristiansand

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry	Change in bone mineral density	5-year follow- up study