Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03753100
Recruitment Status : Enrolling by invitation
First Posted : November 26, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bone Mineral Density Femoral Neck Fractures 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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
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.
Actual Study Start Date : February 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Periprosthetic BMD; anterolateral approach
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
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.

Active Comparator: Periprosthetic BMD; lateral approach
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
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 Measures :
  1. Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry [ Time Frame: 5-year follow- up study ]
    Change in bone mineral density



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753100


Locations
Layout table for location information
Norway
Departement of Orthopaedics, Sorlandet Hospital
Kristiansand, Norway, 4600
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Layout table for investigator information
Principal Investigator: Glen Haugeberg, MD,PhD Department of Rheumatology, Sorlandet hospital, Kristiansand, Norway

Layout table for additonal information
Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT03753100     History of Changes
Other Study ID Numbers: Stein Ugland
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries