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Completed

NCT Number: NCT03974698

Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

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.

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Key information

Conditions

Femoral Neck Fractures Bone Diseases Bone Diseases, Developmental Femoral Fractures Fractures, Bone Genu Valgum Hemiarthroplasty Heterotopic Ossification Hip Fractures Hip Injuries Leg Injuries Leg Length Inequality Musculoskeletal Diseases Ossification, Heterotopic Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

70 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sorlandet Hospital

Kristiansand, 4615, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemiarthroplasty

Procedure

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 outcomes

  1. Leg length

    Time frame: Immediately after surgery

    The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head

Secondary outcomes

  1. Femoral offset

    Time frame: Immediately after surgery

    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: Immediately after surgery

    Stem position in relation to the femoral axis

  3. Heterotopic ossification

    Time frame: 1 year

    Classified as type 1-4 according to Brooker classification

  4. Canal fill ratio

    Time frame: Immediately after surgery

    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 outcomes

  1. Canal Flare index

    Time frame: Immediately after surgery

    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: Immediately after surgery

    Morphology of the proximal femur

  3. Cortical Thickness Index

    Time frame: Immediately after surgery

    the ratio of cortical width minus endosteal width, to cortical width at 10 cm below the tip of lesser trochanter

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jun 5, 2019
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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