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Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

S

Sorlandet Hospital HF

Status

Completed

Conditions

Hemiarthroplasty
Femoral Neck Fractures
Heterotopic Ossification

Treatments

Procedure: Hemiarthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03974698
Raymond Tellefsen

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

70 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

Anterolateral approach
Active Comparator group
Description:
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.
Treatment:
Procedure: Hemiarthroplasty
Lateral approach
Active Comparator group
Description:
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.
Treatment:
Procedure: Hemiarthroplasty

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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