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NCT Number: NCT05461313

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Cancer to the Hip Bone Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedic Surgery, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constrained Liner

Other

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 Mobility

Other

Subjects in this arm will receive a dual mobility cup with the following implant: Avantage Dual Mobility Cup (Zimmer Biomet)

Primary outcomes

  1. 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

Secondary outcomes

  1. Post-operative joint dislocation risk

    Time frame: 3 months

    The 3-months hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

  2. Implant survival

    Time frame: 3 and 6 months

    The 3-months and 6-months implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

  3. Overall survival

    Time frame: 3 and 6 months

    The 3-months and 6-months overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

  4. Post-surgical and prosthesis related complications

    Time frame: 6 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.

  5. Karnofsky Performance Status Score

    Time frame: 3 and 6 months

    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.

  6. Musculoskeletal Tumor Society Score

    Time frame: 3 and 6 months

    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

  7. Harris Hip Score

    Time frame: 3 and 6 months

    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

  8. European Quality of Life - 5 Dimensions Questionnaire

    Time frame: 3 and 6 months

    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

  9. Toronto Extremities Salvage Score for the lower extremity

    Time frame: 3 and 6 months

    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

Other outcomes

  1. Post-operative joint dislocation risk

    Time frame: 12 and 24 months

    The 1-year and 2-year hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

  2. Implant survival

    Time frame: 12 and 24 months

    The 1-year and 2-year implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

  3. Overall survival

    Time frame: 12 and 24 months

    The 1-year and 2-year overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

  4. Post-surgical and prosthesis related complications

    Time frame: 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.

  5. Karnofsky Performance Status Score

    Time frame: 12 and 24 months

    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.

  6. Musculoskeletal Tumor Society Score

    Time frame: 12 and 24 months

    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

  7. Harris Hip Score

    Time frame: 12 and 24 months

    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

  8. European Quality of Life - 5 Dimensions Questionnaire

    Time frame: 12 and 24 months

    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

  9. Toronto Extremities Salvage Score for the lower extremity

    Time frame: 12 and 24 months

    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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Jul 18, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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