Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

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

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.

Study Overview

• Status: Completed
• Conditions: Hemiarthroplasty; Femoral Neck Fractures; Heterotopic Ossification
• Intervention / Treatment: Procedure: Hemiarthroplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kristiansand, Norway, 4615
    • Sorlandet hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 90 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Immediately after surgery
Valgus/varus stem position	Stem position in relation to the femoral axis	Immediately after surgery
Heterotopic ossification	Classified as type 1-4 according to Brooker classification	1 year
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	Immediately after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canal Flare index	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	Immediately after surgery
Dorr classification	Morphology of the proximal femur	Immediately after surgery
Cortical Thickness Index	the ratio of cortical width minus endosteal width, to cortical width at 10 cm below the tip of lesser trochanter	Immediately after surgery

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Investigators: Principal Investigator: Lars Nordsletten, Prof, Oslo University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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. 2022 May 18:11207000221097639. doi: 10.1177/11207000221097639. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: leg length discrepancy; femoral offset; valgus/varus position; Lateral approach; Anterolateral approach
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures; Ossification, Heterotopic
• Other Study ID Numbers: Raymond Tellefsen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No