Language: BG BG
← Back to results
Active (not recruiting) Not applicable NCT05461313

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

No applicable phase (e.g. observational)
Conditions: Metastatic Cancer to the Hip

Sponsor: Rigshospitalet, Denmark

trial.available_in: БГ
Overview
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.
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.
Who can participate
Inclusion Criteria: * Diagnosed with metastatic bone disease of the hip defined as bone lesions in the proximal femur because of secondary malignant growth of a primary cancer located elsewhere or bone lesions in the proximal femur due to hematological malignancies * Determined eligible for total hip arthroplasty for metastatic bone disease of the hip and is planned to undergo surgery at the study site * Provides informed consent prior to initiation of any study-specific activities/procedures 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 provide informed consent
Interventions
Constrained Liner
OTHER
Dual Mobility
OTHER
Locations 1
Denmark (1)
Department of Orthopedic Surgery, Rigshospitalet
Copenhagen
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.09.2022
Completion date
22.04.2028
Registry ID
NCT05461313
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.