Clinical trial NCT03974698: Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach
Official title: Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Hemiarthroplasty
Heterotopic Ossification
Keywords: femoral offset
leg length discrepancy
valgus/varus position
Lateral approach
Anterolateral approach
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2019-06-05
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Leg length
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Femoral offset
timeFrame: Immediately after surgery
measure: Valgus/varus stem position
timeFrame: Immediately after surgery
measure: Heterotopic ossification
timeFrame: 1 year
measure: Canal fill ratio
timeFrame: Immediately after surgery
Other outcomes:
measure: Canal Flare index
timeFrame: Immediately after surgery
measure: Dorr classification
timeFrame: Immediately after surgery
measure: Cortical Thickness Index
timeFrame: Immediately after surgery
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
Study officials:
affiliation: Oslo University Hospital
name: Lars Nordsletten, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Hugo Pripp A, Nordsletten L. Less periprosthetic bone loss following the anterolateral approach to the hip compared with the direct lateral approach. Acta Orthop. 2018 Feb;89(1):23-28. doi: 10.1080/17453674.2017.1387730. Epub 2017 Oct 17.
citation: Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.
citation: Tellefsen RA, Ugland T, Bjorndal MM, Ugland S, Pripp AH, Nordsletten L. Increased risk of high-grade heterotopic ossification using direct lateral approach versus a muscle-sparing anterolateral approach to the hip: radiological results from a randomised trial in patients with a femoral neck fracture treated with hemiarthroplasty. Hip Int. 2023 Jul;33(4):789-796. doi: 10.1177/11207000221097639. Epub 2022 May 18.