Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

Femoral Neck Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974698
• Other study ID #: Raymond Tellefsen
• Status: Completed
• Phase: N/A
• Start date: February 1, 2014
• Est. completion date: July 31, 2018

Study information

• Verified date: May 2019
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Hemiarthroplasty
• Heterotopic Ossification
• Ossification, Heterotopic

Intervention

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.

Locations

Country	Name	City	State
Norway	Sorlandet Hospital	Kristiansand

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg ØH, 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. — View Citation

Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg ØH, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Dorr classification	Morphology of the proximal femur	Immediately after surgery
Other	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
Primary	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	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
Secondary	Valgus/varus stem position	Stem position in relation to the femoral axis	Immediately after surgery
Secondary	Heterotopic ossification	Classified as type 1-4 according to Brooker classification	1 year
Secondary	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