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

Not Applicable

Completed

• Conditions: Bone Mineral Density; Femoral Neck Fractures
• Interventions: 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

• Registration Number: NCT03753100
• Lead Sponsor: Sorlandet Hospital HF

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-02
• Status Verified: 2018-11
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-25
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periprosthetic BMD; anterolateral approach	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	Periprosthetic bone mineral density will be measured using a DXA scanner from GE Lunar Prodigy. The initial scan was performed post-operatively during hospitalization
Periprosthetic BMD; lateral approach	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	Periprosthetic bone mineral density will be measured using DXA scanner from GE Lunar Prodigy.The initial scan was performed post-operatively during hospitalization.

Primary Outcome Measures

Name	Time	Method
Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry	5-year follow- up study	Change in bone mineral density

Trial Locations

Locations (1)

Departement of Orthopaedics, Sorlandet Hospital; 🇳🇴 Kristiansand, Norway