Fully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip

Last updated: April 20, 2024
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Diseases

Treatment

Constrained Liner

Dual Mobility

Clinical Study ID

NCT05461313
H-21078128
  • Ages > 18
  • All Genders

Study Summary

The purpose of the current study is to investigate whether dual mobility liners are non-inferior til constrained liners regarding the post-operative hip joint dislocation risk following total hip replacement in patients with metastatic bone disease of the hip.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with metastatic bone disease of the hip defined as bone lesions in theproximal femur because of secondary malignant growth of a primary cancer locatedelsewhere or bone lesions in the proximal femur due to hematological malignancies
  • Determined eligible for total hip arthroplasty for metastatic bone disease of the hipand is planned to undergo surgery at the study site
  • Provides informed consent prior to initiation of any study-specificactivities/procedures

Exclusion

Exclusion Criteria:

  • Previous osteosynthesis or endoprosthetic surgery of the ipsilateral hip
  • Pelvic reconstruction of the ipsilateral hip
  • Total femoral replacement of the ipsilateral femur
  • It is not surgically viable to insert an acetabular cup and/or a femoral stem
  • Subject is currently or has previously been enrolled in this study
  • Subject is incapable of understanding the patient information or unable to provideinformed consent

Study Design

Total Participants: 146
Treatment Group(s): 2
Primary Treatment: Constrained Liner
Phase:
Study Start date:
September 20, 2022
Estimated Completion Date:
July 31, 2026

Study Description

The use of constrained liners in total hip arthroplasty (THA) in patients with metastatic bone disease of the hip (MBD) has increased at our department in recent years to avoid hip dislocation in this high-risk population. Hip surgeons seldom recommend the use of constrained liners in primary surgery due to the risk of polyethylene wear and high revision rates. An alternative to constrained liners are dual mobility cups, which have been shown to decrease the risk of dislocation in other high-risk THA operations such as revision THA and THA in hip fracture patients, while providing the added benefit of a less restricted range of motion of the joint. This study will investigate whether dual mobility cups are non-inferior to constrained liners regarding the post-operative joint dislocation risk in patients with MBD.

Connect with a study center

  • Department of Orthopedic Surgery, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

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