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Cemented Marathon/Corail Versus Pinnacle/Corail

Primary Purpose

Arthritis of the Hip

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pinnacle/Corail with collar
Marathon/Corail with collar
Pinnacle/Corail without collar
Marathon/Corail without collar
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis of the Hip

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of the femoral head, acute hip fracture or sequelae after hip fracture.

Exclusion Criteria:

  • Active malignant disease, rheumatoid arthritis or other generalised auto-immune arthritic disease,
  • BMI > 35,
  • insulin dependent diabetes mellitus, 0 chronic or recurrent infection,
  • liver disease,
  • Paget's disease,
  • dementia or lack of compliance for other reasons,
  • uncompensated cardiac or pulmonary disease(ASA class 3 or 4). Prosthesis in the contralateral hip does not exclude the patient, but only one hip in each patient can be included in the study.

Sites / Locations

  • Department of Orthopaedic Surgery, Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pinnacle/Corail with collar

Marathon/Corail with collar

Pinnacle/Corail without collar

Marathon/Corail without collar

Arm Description

Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.

Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.

Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.

Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.

Outcomes

Primary Outcome Measures

Polyethylene wear
Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis
Component migration-cup
Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.
Periprosthetic bone mineral density
Differences in bone mineral density around a cemented and an uncemented acetabular component using Dual X-ray absorptiometry. Differences in bone mineral density around an uncemented fully HA-coated femoral component with or without a collar using Dual X-ray absorptiometry.
Component migration-stem
Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.

Secondary Outcome Measures

Clinical outcome
Comparison of clinical results between study groups using HHS and PROMs

Full Information

First Posted
March 21, 2012
Last Updated
February 23, 2016
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01693627
Brief Title
Cemented Marathon/Corail Versus Pinnacle/Corail
Official Title
Cemented Marathon/Corail Versus Pinnacle/Corail. Comparison of Polyethylene Wear, Component Migration and Periprosthetic Bone Mineral Density. A Randomised Study of 48 Hips Using Radiostereometry and Dual-energy X-ray Absorptiometry
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomised, comparative, prospective, single-blinded trial of two hip prosthesis: Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) and Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) There will be a further in-group randomisation to a Corail femoral stem with or without a collar, creating a number of 4 study-groups in total. The aims of the study are: To compare polyethylene wear and migration of the moderately cross-linked Marathon polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon) To evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(RSA) To evaluate the migration patterns and proximal femoral bone density changes around the Corail stems with and without a collar

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of the Hip

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pinnacle/Corail with collar
Arm Type
Active Comparator
Arm Description
Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
Arm Title
Marathon/Corail with collar
Arm Type
Active Comparator
Arm Description
Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
Arm Title
Pinnacle/Corail without collar
Arm Type
Active Comparator
Arm Description
Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
Arm Title
Marathon/Corail without collar
Arm Type
Active Comparator
Arm Description
Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
Intervention Type
Device
Intervention Name(s)
Pinnacle/Corail with collar
Intervention Description
Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
Intervention Type
Device
Intervention Name(s)
Marathon/Corail with collar
Intervention Description
Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
Intervention Type
Device
Intervention Name(s)
Pinnacle/Corail without collar
Intervention Description
Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
Intervention Type
Device
Intervention Name(s)
Marathon/Corail without collar
Intervention Description
Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
Primary Outcome Measure Information:
Title
Polyethylene wear
Description
Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis
Time Frame
After 5 years of follow-up
Title
Component migration-cup
Description
Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.
Time Frame
After 5 years of follow-up
Title
Periprosthetic bone mineral density
Description
Differences in bone mineral density around a cemented and an uncemented acetabular component using Dual X-ray absorptiometry. Differences in bone mineral density around an uncemented fully HA-coated femoral component with or without a collar using Dual X-ray absorptiometry.
Time Frame
After 2 years of follow-up
Title
Component migration-stem
Description
Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.
Time Frame
After 5 years of follow-up
Secondary Outcome Measure Information:
Title
Clinical outcome
Description
Comparison of clinical results between study groups using HHS and PROMs
Time Frame
After 5 years of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of the femoral head, acute hip fracture or sequelae after hip fracture. Exclusion Criteria: Active malignant disease, rheumatoid arthritis or other generalised auto-immune arthritic disease, BMI > 35, insulin dependent diabetes mellitus, 0 chronic or recurrent infection, liver disease, Paget's disease, dementia or lack of compliance for other reasons, uncompensated cardiac or pulmonary disease(ASA class 3 or 4). Prosthesis in the contralateral hip does not exclude the patient, but only one hip in each patient can be included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif I Havelin, MD, PhD
Organizational Affiliation
Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Benedikt A Jonsson, MD
Organizational Affiliation
Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geir Hallan, MD, PhD
Organizational Affiliation
Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ove Furnes, MD, PhD
Organizational Affiliation
Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Clara G Gjesdal, MD, PhD
Organizational Affiliation
Department of Rheumatology, Haukeland University Hospital, Bergen, Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristin Haugan, MA
Organizational Affiliation
Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arne K Skredderstuen, MD
Organizational Affiliation
Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Terje Stokke
Organizational Affiliation
Department of Radiology, Haukeland University Hospital, Bergen, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthopaedic Surgery, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5096
Country
Norway

12. IPD Sharing Statement

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Cemented Marathon/Corail Versus Pinnacle/Corail

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