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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Cancer to the Hip
• Intervention / Treatment: Other: Constrained Liner; Other: Dual Mobility

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.

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Orthopedic Surgery, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Constrained Liner	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 Cup	Other: Dual Mobility; Subjects in this arm will receive a dual mobility cup with the following implant: Avantage Dual Mobility Cup (Zimmer Biomet)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Afrim Iljazi, MD, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): April 22, 2028

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hip Replacement; Total Hip Arthroplasty; Metastatic Bone Disease; Constrained Liner; Dual Mobility; Orthopaedic Oncology
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases
• Other Study ID Numbers: H-21078128

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No