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

NCT05461313 | Active Not Recruiting

• 1 other identifier: H-21078128
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer to the Hip

Keywords

Metastatic Bone Disease; Total Hip Arthroplasty; Hip Replacement; Constrained Liner; Dual Mobility; Orthopaedic Oncology

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (9)

• Post-operative joint dislocation risk

  3 months

• Implant survival

  3 and 6 months

• Overall survival

  3 and 6 months

• Post-surgical and prosthesis related complications

  6 months

• Karnofsky Performance Status Score

  3 and 6 months

Other Outcomes (9)

• Post-operative joint dislocation risk

  12 and 24 months

• Implant survival

  12 and 24 months

• Overall survival

  12 and 24 months

Study Arms (2)

Constrained Liner

OTHER

Other: Constrained Liner

Dual Mobility Cup

OTHER

Other: Dual Mobility

Interventions

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)

Constrained Liner

Dual Mobility OTHER

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

Dual Mobility Cup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Orthopedic Surgery, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36934286 DERIVED

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Afrim Iljazi, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: A Randomized, Open-Label, Two-Arm, Non-Inferiority Study

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 18, 2022
• Study Start: September 20, 2022
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): April 22, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

DK (1)