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Migration in Total Hip Arthroplasty With a Cemented BiMobile Cup: Better Stability With More Cement? (Be-Mobile)

Primary Purpose

Total Hip Arthroplasty, Osteoarthritis, Hip

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
BiMobile standard cement
BiMobile larger cement
Avantage standard cement
Sponsored by
JointResearch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Hip Arthroplasty focused on measuring primary total hip arthroplasty, RSA, cement, Dual mobility cup

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • OLVGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

BiMobile standard cement

BiMobile larger cement

Avantage standard cement

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Migration of the acetabular cup
Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).
Patient reported outcomes on physical functioning
Difference in patient reported outcomes on physical functioning following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the Hip disability and Osteoarthritis Outcome Score Physical Short form (HOOS-PS). Interval level scores from 0 (no difficulty) to 100 (extreme difficulty).
Patient reported outcomes on quality of life.
Difference in patient reported outcomes on quality of life, following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the EuroQol 5 Dimensions (EQ-5D). A higher score means a worse quality of life, a lower score means a better quality of life. For the visual analogue scale (part of the EQ-5D), the lowest means the worst an the highest score means the best health score.
Patient reported outcomes on pain
Difference in patient reported outcomes on pain, following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the Numeric Ratin Scale (NRS) for pain in rest and during weight bearing. 0 means no pain, 10 means the most extreme pain.
Patient Satisfaction
patient satisfaction will be scored with an anchor question about general daily functioning.

Full Information

First Posted
July 4, 2019
Last Updated
January 20, 2022
Sponsor
JointResearch
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1. Study Identification

Unique Protocol Identification Number
NCT04049279
Brief Title
Migration in Total Hip Arthroplasty With a Cemented BiMobile Cup: Better Stability With More Cement?
Acronym
Be-Mobile
Official Title
Migration in Total Hip Arthroplasty With a Cemented BiMobile Cup: Better Stability With More Cement? (Be-Mobile)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JointResearch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Rationale: Total hip arthroplasty (THA) is a commonly performed surgery in patients with end-stage osteoarthritis (OA) of the hip. Although it is known as a successful procedure, (recurrent) dislocation after THA is a major problem and results in a deterioration in quality of life. Dislocation after THA is the number one cause of early revision surgery. Dual-Mobility (DM) acetabular cups should provide more stability and biomechanically reduce the risk of (early) dislocation. Potential disadvantages of DM cups are increased liner wear, psoas impingement and loosening. This might result in more revision surgery at mid- and longer-term follow-up for the cemented cups. If the cemented fixation technique improves, this might diminish the disadvantages of more revisions due to loosening in cemented cups. High quality evidence guiding the best technique for cemented fixation is however lacking. The risk of implant loosening might be reduced by increasing the amount of cement used for cup fixation. It is currently unknown whether size of the implant, and thereby the amount of cement, affects stability and survival. To fill this gap in knowledge, this study will compare cup migration, as an indicator for loosening, in a new dual mobility cup (BiMobile, Waldemar Link GmbH & Co. KG, Hamburg, Germany), using a larger or smaller cup size (and thereby different amounts of cement: approximately 2mm or 4mm cement mantle). These results will also be compared with the Avantage cup (ZimmerBiomet), which is yet considered as a standard dual mobility cup in the Netherlands. Migration will be measured with Rontgen Stereophotogrammetry Analysis (RSA), which is currently the gold standard for measuring early migration and predicting long term survival. A relatively new and less intensive way to measure migration of prostheses is the use of computer tomography (CT) scans, however there is still little scientific evidence on how accurately this can be done. This study therefore also measures the accuracy with which migration is measured, between CT scans and RSA. 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 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: At the outpatient clinic of OLVG, all patients who meet the criteria to undergo a cemented THA will be screened for the in- and exclusion criteria. Intervention: Group A: 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. Group B: 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. Group C: 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. Main study parameters/endpoints: Migration of the acetabular cup at two year postoperative, measured with RSA and CT. RSA x-rays will be collected at discharge, 6 weeks, 6 months, 1 year and 2 years after surgery. CT scans will be collected at discharge and 2 years after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Arthroplasty, Osteoarthritis, Hip
Keywords
primary total hip arthroplasty, RSA, cement, Dual mobility cup

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BiMobile standard cement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BiMobile larger cement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Avantage standard cement
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
BiMobile standard cement
Intervention Description
BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
Intervention Type
Procedure
Intervention Name(s)
BiMobile larger cement
Intervention Description
BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.
Intervention Type
Procedure
Intervention Name(s)
Avantage standard cement
Intervention Description
Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
Primary Outcome Measure Information:
Title
Migration of the acetabular cup
Description
Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
Migration of the acetabular cup
Description
Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).
Time Frame
6 weeks, 6 months and 1 year postoperative
Title
Patient reported outcomes on physical functioning
Description
Difference in patient reported outcomes on physical functioning following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the Hip disability and Osteoarthritis Outcome Score Physical Short form (HOOS-PS). Interval level scores from 0 (no difficulty) to 100 (extreme difficulty).
Time Frame
prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Title
Patient reported outcomes on quality of life.
Description
Difference in patient reported outcomes on quality of life, following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the EuroQol 5 Dimensions (EQ-5D). A higher score means a worse quality of life, a lower score means a better quality of life. For the visual analogue scale (part of the EQ-5D), the lowest means the worst an the highest score means the best health score.
Time Frame
prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Title
Patient reported outcomes on pain
Description
Difference in patient reported outcomes on pain, following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the Numeric Ratin Scale (NRS) for pain in rest and during weight bearing. 0 means no pain, 10 means the most extreme pain.
Time Frame
prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Title
Patient Satisfaction
Description
patient satisfaction will be scored with an anchor question about general daily functioning.
Time Frame
prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loes van Beers, MSc
Phone
+31(0)20-5993653
Email
l.w.a.h.vanbeers@olvg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Nienk Willigenburg, PhD
Phone
+31(0)20-5992415
Email
n.w.willigenburg@olvg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Poolman, MD, PhD
Organizational Affiliation
OLVG
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLVG
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loes van Beers, MSc
Phone
+31(0)20-5993653
Email
l.w.a.h.vanbeers@olvg.nl
First Name & Middle Initial & Last Name & Degree
Nienke Willigenburg, PhD
Phone
+31(0)20-5992415
Email
n.w.willigenburg@olvg.nl

12. IPD Sharing Statement

Learn more about this trial

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

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