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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fully Constrained Acetabular Liner Versus Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip - A Randomized, Open-Label, Two-Arm, Non-Inferiority Study Evaluating the Post-Operative Hip Dislocation Rate

Conditions
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Metastatic Cancer to the Hip

Intervention / Treatment
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* Other: Constrained Liner
* Other: Dual Mobility


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, Open-Label, Two-Arm, Non-Inferiority Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Constrained Liner<br> | Other: Constrained Liner<br>* Subjects in this arm will receive a constrained liner (Freedom or G7 Freedom Constrained Acetabular Liner, Zimmer Biomet)<br>|
| Other: Dual Mobility Cup<br> | Other: Dual Mobility<br>* Subjects in this arm will receive a dual mobility cup (Avantage Dual Mobility Liner, Zimmer Biomet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative joint dislocation risk | The 6-months hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner for the surgical treatment of MBD | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative joint dislocation risk | The 3-months hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner. | 3 months | 
| Implant survival | The 3-months and 6-months implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner. | 3 and 6 months | 
| Overall survival | The 3-months and 6-months overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner. | 3 and 6 months | 
| Post-surgical and prosthesis related complications | The incidence of post-surgical and prosthesis-related complications in patients receiving a dual mobility cup compared to patients receiving a constrained liner. These include but are not limited to deep venous thrombosis, pulmonary embolism, wound infections, periprosthetic infections, periprosthetic fractures etc. | 6 months | 
| Karnofsky Performance Status Score | The 3-months and 6-months Karnofsky Performance Status Score in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point. | 3 and 6 months | 
| Musculoskeletal Tumor Society Score | The 3-months and 6-months MSTS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point | 3 and 6 months | 
| Harris Hip Score | The 3-months and 6-months HHS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point | 3 and 6 months | 
| European Quality of Life - 5 Dimensions Questionnaire | The 3-months and 6-months Eq-5d score in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point | 3 and 6 months | 
| Toronto Extremities Salvage Score for the lower extremity | The 3-months and 6-months TESS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Bone Disease, Total Hip Arthroplasty, Hip Replacement, Constrained Liner, Dual Mobility, Orthopaedic Oncology