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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Constrained Liner | Other |
| |
| Dual Mobility Cup | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Constrained Liner | Other | Subjects in this arm will receive a constrained liner with one of the following implants: Freedom Constrained Acetabular Liner (Zimmer Biomet), G7 Freedom Constrained Acetabular Liner (Zimmer Biomet) or Lubinus Acetabular Cup with a safety ring (LINK) |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative joint dislocation risk | The 1-year and 2-year hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner. | 12 and 24 months |
| Implant survival |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Afrim Iljazi, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedic Surgery, Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36934286 | Derived | Iljazi A, Sorensen MS, Weber KS, Villadsen A, Eriksson F, Petersen MM. Fully constrained acetabular liner vs. dual mobility hip joint in the surgical treatment of metastatic bone disease of the hip: study protocol for a randomized, open-label, two-arm, non-inferiority trial evaluating the post-operative hip dislocation rate. Trials. 2023 Mar 18;24(1):204. doi: 10.1186/s13063-023-07237-9. |
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| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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A Randomized, Open-Label, Two-Arm, Non-Inferiority Study
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| Dual Mobility | Other | Subjects in this arm will receive a dual mobility cup with the following implant: Avantage Dual Mobility Cup (Zimmer Biomet) |
|
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 |
The 1-year and 2-year implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
| 12 and 24 months |
| Overall survival | The 1-year and 2-year overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner. | 12 and 24 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. | 24 months |
| Karnofsky Performance Status Score | The 1-year and 2-year 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. | 12 and 24 months |
| Musculoskeletal Tumor Society Score | The 1-year and 2-year MSTS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point | 12 and 24 months |
| Harris Hip Score | The 1-year and 2-year HHS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point | 12 and 24 months |
| European Quality of Life - 5 Dimensions Questionnaire | The 1-year and 2-year 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 | 12 and 24 months |
| Toronto Extremities Salvage Score for the lower extremity | The 1-year and 2-year TESS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point | 12 and 24 months |