Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach

NCT03974698 | Completed

• 1 other identifier: Raymond Tellefsen
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fractures; Hemiarthroplasty; Heterotopic Ossification

Keywords

femoral offset; leg length discrepancy; valgus/varus position; Lateral approach; Anterolateral approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Femoral offset

  Immediately after surgery

• Valgus/varus stem position

  Immediately after surgery

• Heterotopic ossification

  1 year

• Canal fill ratio

  Immediately after surgery

Other Outcomes (3)

• Canal Flare index

  Immediately after surgery

• Dorr classification

  Immediately after surgery

• Cortical Thickness Index

  Immediately after surgery

Study Arms (2)

Anterolateral approach

ACTIVE COMPARATOR

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

Lateral approach

ACTIVE COMPARATOR

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

Interventions

Hemiarthroplasty PROCEDURE

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.

Anterolateral approach; Lateral approach

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Hospital

Kristiansand, 4615, Norway

Location

Related Publications (3)

• 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.

  PMID: 29037093 BACKGROUND

• 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.

  PMID: 29789919 BACKGROUND

• 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.

  PMID: 35585787 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures; Ossification, Heterotopic; Leg Length Inequality; Genu Valgum

Interventions

Hemiarthroplasty

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Lars Nordsletten, Prof

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants attempted masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 5, 2019
• Study Start: February 1, 2014
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2018
• Last Updated: January 25, 2021

Record last verified: 2019-05

Locations

NO (1)