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Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

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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

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.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Hemiarthroplasty Heterotopic Ossification Procedure: Hemiarthroplasty 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). 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Participants attempted masked.
Primary Purpose: Treatment
Official Title: Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2018

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Valgus/varus stem position [ Time Frame: Up to 6 months ]
    Stem position in relation to the femoral axis

  3. Heterotopic ossification [ Time Frame: Up to 6 months ]
    Classified as type 1-4 according to Brooker classification

  4. 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


Other Outcome Measures:
  1. 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

  2. Dorr classification [ Time Frame: Up to 6 months ]
    Morphology of the proximal femur

  3. 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



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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): NCT03974698


Locations
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Norway
Sorlandet Hospital
Kristiansand, Norway, 4615
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
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Principal Investigator: Lars Nordsletten, Prof Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Sorlandet Hospital HF:

Publications:
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Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT03974698     History of Changes
Other Study ID Numbers: Raymond Tellefsen
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorlandet Hospital HF:
femoral offset
leg length discrepancy
valgus/varus position
Lateral approach
Anterolateral approach
Additional relevant MeSH terms:
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Ossification, Heterotopic
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Pathologic Processes