NCT05461313

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Cancer to the Hip

Interventions

Type	Name	Description
OTHER	Constrained Liner	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)
OTHER	Dual Mobility	Subjects in this arm will receive a dual mobility cup with the following implant: Avantage Dual Mobility Cup (Zimmer Biomet)

Timeline

• Start date: 2022-09-20
• Primary completion: 2025-01-31
• Completion: 2026-07-31
• First posted: 2022-07-18
• Last updated: 2024-04-23

Locations

1 site across 1 country: Denmark