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Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

Primary Purpose

Femoral Neck Fractures, Hemiarthroplasty, Heterotopic Ossification

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hemiarthroplasty
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring femoral offset, leg length discrepancy, valgus/varus position, Lateral approach, Anterolateral approach

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sorlandet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anterolateral approach

Lateral approach

Arm 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.

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.

Outcomes

Primary Outcome Measures

Leg length
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

Femoral offset
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
Stem position in relation to the femoral axis
Heterotopic ossification
Classified as type 1-4 according to Brooker classification
Canal fill ratio
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

Full Information

First Posted
May 27, 2019
Last Updated
January 20, 2021
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT03974698
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures, Hemiarthroplasty, Heterotopic Ossification
Keywords
femoral offset, leg length discrepancy, valgus/varus position, Lateral approach, Anterolateral approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Participants attempted masked.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anterolateral approach
Arm Type
Active Comparator
Arm 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.
Arm Title
Lateral approach
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Hemiarthroplasty
Intervention Description
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 Measure Information:
Title
Leg length
Description
The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head
Time Frame
Immediately after surgery
Secondary Outcome Measure Information:
Title
Femoral offset
Description
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
Time Frame
Immediately after surgery
Title
Valgus/varus stem position
Description
Stem position in relation to the femoral axis
Time Frame
Immediately after surgery
Title
Heterotopic ossification
Description
Classified as type 1-4 according to Brooker classification
Time Frame
1 year
Title
Canal fill ratio
Description
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
Time Frame
Immediately after surgery
Other Pre-specified Outcome Measures:
Title
Canal Flare index
Description
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
Time Frame
Immediately after surgery
Title
Dorr classification
Description
Morphology of the proximal femur
Time Frame
Immediately after surgery
Title
Cortical Thickness Index
Description
the ratio of cortical width minus endosteal width, to cortical width at 10 cm below the tip of lesser trochanter
Time Frame
Immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, Prof
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital
City
Kristiansand
ZIP/Postal Code
4615
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
29037093
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.
Results Reference
background
PubMed Identifier
29789919
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.
Results Reference
background
PubMed Identifier
35585787
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.
Results Reference
derived

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Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

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