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

NCT03753100 | Completed

• 1 other identifier: Stein Ugland
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Mineral Density; Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

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

  Change in bone mineral density

  5-year follow- up study

Study Arms (2)

Periprosthetic BMD; anterolateral approach

ACTIVE COMPARATOR

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

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

Periprosthetic BMD; lateral approach

ACTIVE COMPARATOR

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

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

Interventions

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 OTHER

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.

Periprosthetic BMD; anterolateral approach; Periprosthetic BMD; lateral approach

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Departement of Orthopaedics, Sorlandet Hospital

Kristiansand, 4600, Norway

Location

Related Publications (1)

• Ugland SH, Ugland TO, Haugeberg G, Pripp AH, Nordsletten L. Periprosthetic bone mineral density, assessed using dual energy x-ray absorptiometry, following arthroplasty in patients with femoral neck fracture: 5-year outcomes of a randomized controlled trial. J Int Med Res. 2024 Sep;52(9):3000605241276491. doi: 10.1177/03000605241276491.

  PMID: 39268760 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Glen Haugeberg, MD,PhD

  Department of Rheumatology, Sorlandet hospital, Kristiansand, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 26, 2018
• Study Start: February 1, 2014
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: March 26, 2020

Record last verified: 2018-11

Locations

NO (1)