Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

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: NCT03974698
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF

Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date June 5, 2019
Actual Study Start Date  ICMJE February 1, 2014
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
Leg length [ Time Frame: Up to 6 months ]
The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Femoral offset [ Time Frame: Up to 6 months ]
    The distance between the longitudinal axis of the femur to the centre of the femoral head and the distance from the centre of the femoral head to a perpendicular line passing through the medial edge of the teardrop
  • Valgus/varus stem position [ Time Frame: Up to 6 months ]
    Stem position in relation to the femoral axis
  • Heterotopic ossification [ Time Frame: Up to 6 months ]
    Classified as type 1-4 according to Brooker classification
  • Canal fill ratio [ Time Frame: Up to 6 months ]
    Was evaluated at the following points; 2 cm above the lower trochanter, at the tip of the lower trochanter, 2 cm and 7 cm below the tip of lesser trochanter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2019)
  • Canal Flare index [ Time Frame: Up to 6 months ]
    the ratio of the intracortical width of the femur at 20 mm proximal to the tip of lesser trochanter and isthmus at 10 cm distally
  • Dorr classification [ Time Frame: Up to 6 months ]
    Morphology of the proximal femur
  • Cortical Thickness Index [ Time Frame: Up to 6 months ]
    the ratio of cortical width minus endosteal width, to cortical width at 10 cm below the tip of lesser trochanter
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach
Official Title  ICMJE Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.
Brief Summary Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months.
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). This study is a follow-up on the same study population.

150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated With either anterolateral og Direct lateral surgical approach. Investigators want to compare the radiological features of the femoral stem between the two Groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Participants attempted masked.
Primary Purpose: Treatment
Condition  ICMJE
  • Femoral Neck Fractures
  • Hemiarthroplasty
  • Heterotopic Ossification
Intervention  ICMJE Procedure: Hemiarthroplasty
Radiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up.
Study Arms  ICMJE
  • Active Comparator: Anterolateral approach
    Standard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip.
    Intervention: Procedure: Hemiarthroplasty
  • Active Comparator: Lateral approach
    Standard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip.
    Intervention: Procedure: Hemiarthroplasty
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2019)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974698
Other Study ID Numbers  ICMJE Raymond Tellefsen
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sorlandet Hospital HF
Study Sponsor  ICMJE Sorlandet Hospital HF
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars Nordsletten, Prof Oslo University Hospital
PRS Account Sorlandet Hospital HF
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP