Back to resultsFully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip
Primary Purpose
Metastatic Cancer to the Hip
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Constrained Liner
Dual Mobility
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer to the Hip focused on measuring Metastatic Bone Disease, Total Hip Arthroplasty, Hip Replacement, Constrained Liner, Dual Mobility, Orthopaedic Oncology
Eligibility Criteria
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
Sites / Locations
- Department of Orthopedic Surgery, RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Constrained Liner
Dual Mobility Cup
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Implant survival
The 3-months and 6-months implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Overall survival
The 3-months and 6-months overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
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.
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.
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05461313
Brief Title
Fully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer to the Hip
Keywords
Metastatic Bone Disease, Total Hip Arthroplasty, Hip Replacement, Constrained Liner, Dual Mobility, Orthopaedic Oncology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized, Open-Label, Two-Arm, Non-Inferiority Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Constrained Liner
Arm Type
Other
Arm Title
Dual Mobility Cup
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Constrained Liner
Intervention Description
Subjects in this arm will receive a constrained liner (Freedom or G7 Freedom Constrained Acetabular Liner, Zimmer Biomet)
Intervention Type
Other
Intervention Name(s)
Dual Mobility
Intervention Description
Subjects in this arm will receive a dual mobility cup (Avantage Dual Mobility Liner, Zimmer Biomet)
Primary Outcome Measure Information:
Title
Post-operative joint dislocation risk
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Post-operative joint dislocation risk
Description
The 3-months hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Time Frame
3 months
Title
Implant survival
Description
The 3-months and 6-months implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Time Frame
3 and 6 months
Title
Overall survival
Description
The 3-months and 6-months overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Time Frame
3 and 6 months
Title
Post-surgical and prosthesis related complications
Description
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.
Time Frame
6 months
Title
Karnofsky Performance Status Score
Description
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.
Time Frame
3 and 6 months
Title
Musculoskeletal Tumor Society Score
Description
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
Time Frame
3 and 6 months
Title
Harris Hip Score
Description
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
Time Frame
3 and 6 months
Title
European Quality of Life - 5 Dimensions Questionnaire
Description
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
Time Frame
3 and 6 months
Title
Toronto Extremities Salvage Score for the lower extremity
Description
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
Time Frame
3 and 6 months
Other Pre-specified Outcome Measures:
Title
Post-operative joint dislocation risk
Description
The 1-year and 2-year hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Time Frame
12 and 24 months
Title
Implant survival
Description
The 1-year and 2-year implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Time Frame
12 and 24 months
Title
Overall survival
Description
The 1-year and 2-year overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.
Time Frame
12 and 24 months
Title
Post-surgical and prosthesis related complications
Description
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.
Time Frame
24 months
Title
Karnofsky Performance Status Score
Description
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.
Time Frame
12 and 24 months
Title
Musculoskeletal Tumor Society Score
Description
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
Time Frame
12 and 24 months
Title
Harris Hip Score
Description
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
Time Frame
12 and 24 months
Title
European Quality of Life - 5 Dimensions Questionnaire
Description
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
Time Frame
12 and 24 months
Title
Toronto Extremities Salvage Score for the lower extremity
Description
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
Time Frame
12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afrim Iljazi, MD
Phone
+4535456125
Email
afrim.iljazi.04@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afrim Iljazi, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedic Surgery, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afrim Iljazi, MD
Phone
+4535456125
Email
afrim.iljazi.04@regionh.dk
12. IPD Sharing Statement
Learn more about this trial
Fully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip
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