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

Primary Purpose

Bone Mineral Density, Femoral Neck Fractures

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
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
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bone Mineral Density

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departement of Orthopaedics, Sorlandet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Periprosthetic BMD; anterolateral approach

Periprosthetic BMD; lateral approach

Arm Description

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 bone mineral density will be measured using DXA scanner from GE Lunar Prodigy.The initial scan was performed post-operatively during hospitalization.

Outcomes

Primary Outcome Measures

Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry
Change in bone mineral density

Secondary Outcome Measures

Full Information

First Posted
November 21, 2018
Last Updated
March 25, 2020
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT03753100
Brief Title
Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients; a 5-year Follow up Study
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Mineral Density, Femoral Neck Fractures

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periprosthetic BMD; anterolateral approach
Arm Type
Active Comparator
Arm Description
Periprosthetic bone mineral density will be measured using a DXA scanner from GE Lunar Prodigy. The initial scan was performed post-operatively during hospitalization
Arm Title
Periprosthetic BMD; lateral approach
Arm Type
Active Comparator
Arm Description
Periprosthetic bone mineral density will be measured using DXA scanner from GE Lunar Prodigy.The initial scan was performed post-operatively during hospitalization.
Intervention Type
Other
Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry
Description
Change in bone mineral density
Time Frame
5-year follow- up study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen Haugeberg, MD,PhD
Organizational Affiliation
Department of Rheumatology, Sorlandet hospital, Kristiansand, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Orthopaedics, Sorlandet Hospital
City
Kristiansand
ZIP/Postal Code
4600
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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