Clinical trial NCT05461313: 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
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Cancer to the Hip
Keywords: Metastatic Bone Disease
Total Hip Arthroplasty
Hip Replacement
Constrained Liner
Dual Mobility
Orthopaedic Oncology
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Open-Label, Two-Arm, Non-Inferiority Study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-operative joint dislocation risk
timeFrame: 6 months
Secondary outcomes:
measure: Post-operative joint dislocation risk
timeFrame: 3 months
measure: Implant survival
timeFrame: 3 and 6 months
measure: Overall survival
timeFrame: 3 and 6 months
measure: Post-surgical and prosthesis related complications
timeFrame: 6 months
measure: Karnofsky Performance Status Score
timeFrame: 3 and 6 months
measure: Musculoskeletal Tumor Society Score
timeFrame: 3 and 6 months
measure: Harris Hip Score
timeFrame: 3 and 6 months
measure: European Quality of Life - 5 Dimensions Questionnaire
timeFrame: 3 and 6 months
measure: Toronto Extremities Salvage Score for the lower extremity
timeFrame: 3 and 6 months
Other outcomes:
measure: Post-operative joint dislocation risk
timeFrame: 12 and 24 months
measure: Implant survival
timeFrame: 12 and 24 months
measure: Overall survival
timeFrame: 12 and 24 months
measure: Post-surgical and prosthesis related complications
timeFrame: 24 months
measure: Karnofsky Performance Status Score
timeFrame: 12 and 24 months
measure: Musculoskeletal Tumor Society Score
timeFrame: 12 and 24 months
measure: Harris Hip Score
timeFrame: 12 and 24 months
measure: European Quality of Life - 5 Dimensions Questionnaire
timeFrame: 12 and 24 months
measure: Toronto Extremities Salvage Score for the lower extremity
timeFrame: 12 and 24 months
Locations:
city: Copenhagen
country: Denmark
facility: Department of Orthopedic Surgery, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Afrim Iljazi, MD
role: PRINCIPAL_INVESTIGATOR
References: