Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?

NCT04049279 | Recruiting DMC

• 1 other identifier: NL64196.100.17
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented total hip arthroplasty (THA). Additionally, the results of the BiMobile cup will be compared to the Avantage cup, which is placed with a standard cup size, resulting in a cement mantle of approximately 2 mm. Study design: A prospective single centre blinded randomised controlled trial. Study population: All patients who meet the criteria to undergo a cemented THA.

Conditions

Total Hip Arthroplasty; Osteoarthritis, Hip

Keywords

primary total hip arthroplasty; RSA; cement; Dual mobility cup

Outcome Measures

Primary Outcomes (1)

• Migration of the acetabular cup

  Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).

  2 years postoperative

Secondary Outcomes (5)

• Migration of the acetabular cup

  6 weeks, 6 months and 1 year postoperative

• Patient reported outcomes on physical functioning

  prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery

• Patient reported outcomes on quality of life.

  prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery

• Patient reported outcomes on pain

  prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery

• Patient Satisfaction

  prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery

Study Arms (3)

BiMobile standard cement

ACTIVE COMPARATOR

25 patients will receive a cemented THA with a BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.

Procedure: BiMobile standard cement

BiMobile larger cement

ACTIVE COMPARATOR

25 patients will receive a cemented THA with a BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.

Procedure: BiMobile larger cement

Avantage standard cement

ACTIVE COMPARATOR

25 patients will receive a cemented THA with an Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.

Procedure: Avantage standard cement

Interventions

BiMobile standard cement PROCEDURE

BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.

BiMobile standard cement

BiMobile larger cement PROCEDURE

BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.

BiMobile larger cement

Avantage standard cement PROCEDURE

Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.

Avantage standard cement

Eligibility Criteria

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

You may qualify if:

• Patient requiring an elective primary cemented THA.
• Male patient ≥70 years old and female patient ≥65 years old.
• Ability and willingness to follow instructions and to return for follow-up evaluations.
• The patient is able to understand the meaning of the study and is willing to sign informed consent.
• Understanding the Dutch language.

You may not qualify if:

• The patient is morbidly obese, defined as Body Mass Index (BMI) of ≥ 40.
• The patient is expected to need lower limb joint replacement for another joint within one year.
• The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
• The patient has a deformity or disease located in other joints than the hip that needs surgery and that is limiting their ability to walk.
• The patient has an active or suspected latent infection in or around the hip joint.
• The patient's bone stock is compromised by a disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
• The patient is unable or unwilling to sign informed consent for this study.
• The patient is deemed unsuitable for participation in the study based on the investigator's judgment.

Sponsors & Collaborators

• JointResearch: lead

Study Sites (1)

OLVG

Amsterdam, 1091 AC, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rudolf Poolman, MD, PhD

  OLVG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loes van Beers, MSc

CONTACT

+31(0)20-5993653; l.w.a.h.vanbeers@olvg.nl

Nienk Willigenburg, PhD

CONTACT

+31(0)20-5992415; n.w.willigenburg@olvg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: August 8, 2019
• Study Start: January 1, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

NL (1)