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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05461313

Collaborator

(none)

150

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer to the Hip	Other: Constrained Liner Other: Dual Mobility	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Randomized, Open-Label, Two-Arm, Non-Inferiority StudyA Randomized, Open-Label, Two-Arm, Non-Inferiority Study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jul 31, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Constrained Liner

Other: Constrained Liner

Subjects in this arm will receive a constrained liner (Freedom or G7 Freedom Constrained Acetabular Liner, Zimmer Biomet)

Other: Dual Mobility Cup

Other: Dual Mobility

Subjects in this arm will receive a dual mobility cup (Avantage Dual Mobility Liner, Zimmer Biomet)

Outcome Measures

Primary Outcome Measures

6 months post-operative joint dislocation risk [6 months]
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

Secondary Outcome Measures

Post-operative joint dislocation risk [3, 12 and 24 months]
The 3-months, 1-year and 2-year hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Implant survival [3, 6, 12 and 24 months]
The 3-months, 6-months, 1-year and 2-year implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Overall survival [3, 6, 12 and 24 months]
The 3-months, 6-months, 1-year and 2-year overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Post-surgical and prosthesis related complications [24 months]
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.
Karnofsky Performance Status Score [3, 6, 12 and 24 months]
The 3-months, 6-months, 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.
Musculoskeletal Tumor Society Score [3, 6, 12 and 24 months]
The 3-months, 6-months, 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
Harris Hip Score [3, 6, 12 and 24 months]
The 3-months, 6-months, 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
European Quality of Life - 5 Dimensions Questionnaire [3, 6, 12 and 24 months]
The 3-months, 6-months, 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
Toronto Extremities Salvage Score for the lower extremity [3, 6, 12 and 24 months]
The 3-months, 6-months, 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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