Metastatic Cancer to the HipNCT05461313
Fully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip
A study testing Constrained Liner and Dual Mobility in people with Metastatic Cancer to the Hip, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer to the Hip
- What is being tested?
- Constrained Liner and Dual Mobility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Sep 2022to 22 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Orthopedic Surgery, Rigshospitalet
Copenhagen, 2100
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Cancer to the Hip
- Being tested
- Constrained Liner, Dual Mobility
- Keywords
- Metastatic Bone Disease, Total Hip Arthroplasty, Hip Replacement, Constrained Liner, Dual Mobility, Orthopaedic Oncology
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constrained LinerOther
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)
Dual MobilityOther
Subjects in this arm will receive a dual mobility cup with the following implant: Avantage Dual Mobility Cup (Zimmer Biomet)
| Study group | Role | What they receive |
|---|---|---|
| Constrained Liner | Other | Not described Receives: Other: Constrained Liner |
| Dual Mobility Cup | Other | Not described Receives: Other: Dual Mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start20 Sep 2022
- Primary completion22 Oct 2026 (estimated)
- Study completion22 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Cancer to the HipStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Open-Label, Two-Arm, Non-Inferiority Study
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afrim Iljazi, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Afrim Iljazi, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461313
- Sponsor's protocol ID
- H-21078128
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36934286
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05461313
- Acronym / sponsor ID
- H-21078128
- Conditions
- Metastatic Cancer to the Hip
- Keywords
- Metastatic Bone Disease, Total Hip Arthroplasty, Hip Replacement, Constrained Liner, Dual Mobility, Orthopaedic Oncology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 22 Oct 2026 (estimated)
- Study completion
- 22 Apr 2028 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized, Open-Label, Two-Arm, Non-Inferiority Study
| Arm | Type | Receives |
|---|---|---|
| Constrained Liner | Other | Other: Constrained Liner |
| Dual Mobility Cup | Other | Other: Dual Mobility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constrained LinerSubjects 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 | Constrained Liner |
| Dual MobilitySubjects in this arm will receive a dual mobility cup with the following implant: Avantage Dual Mobility Cup (Zimmer Biomet) | Other | Dual Mobility Cup |
Primary outcome
Post-operative joint dislocation risk
Time frame: 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
9 secondary outcomes
Post-operative joint dislocation risk
Time frame: 3 months
Implant survival
Time frame: 3 and 6 months
Overall survival
Time frame: 3 and 6 months
Post-surgical and prosthesis related complications
Time frame: 6 months
Karnofsky Performance Status Score
Time frame: 3 and 6 months
Musculoskeletal Tumor Society Score
Time frame: 3 and 6 months
Harris Hip Score
Time frame: 3 and 6 months
European Quality of Life - 5 Dimensions Questionnaire
Time frame: 3 and 6 months
Toronto Extremities Salvage Score for the lower extremity
Time frame: 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Derived from this study: PubMed 36934286Iljazi 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.
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afrim Iljazi, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constrained Liner and Dual Mobility in people with Metastatic Cancer to the Hip, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative joint dislocation risk (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.