Clinical trial · Interventional
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
NCT05461313CI-TRIAL-00109205active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer to the Hip | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Constrained Liner | Other | — | UNRESOLVED |
| Dual Mobility | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Constrained Liner
- interventionNames
- Other: Constrained Liner
- type
- OTHER
- label
- Dual Mobility Cup
- interventionNames
- Other: Dual Mobility
Primary outcomes (1)
- measure
- Post-operative joint dislocation risk
- timeFrame
- 6 months
- 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
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDIljazi 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. PMID 36934286