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Cemented Marathon/Corail Versus Pinnacle/Corail

NCT ID: NCT01693627

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2022-01-31

Brief Summary

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A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:

1. 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
2. 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

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Detailed Description

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Conditions

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Arthritis of the Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pinnacle/Corail with collar

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.

Group Type ACTIVE_COMPARATOR

Pinnacle/Corail with collar

Intervention Type DEVICE

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.

Marathon/Corail with collar

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.

Group Type ACTIVE_COMPARATOR

Marathon/Corail with collar

Intervention Type DEVICE

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.

Pinnacle/Corail without collar

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.

Group Type ACTIVE_COMPARATOR

Pinnacle/Corail without collar

Intervention Type DEVICE

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.

Marathon/Corail without collar

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.

Group Type ACTIVE_COMPARATOR

Marathon/Corail without collar

Intervention Type DEVICE

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.

Interventions

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Pinnacle/Corail with collar

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

Marathon/Corail with collar

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

Pinnacle/Corail without collar

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

Marathon/Corail without collar

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

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leif I Havelin, MD, PhD

Role: STUDY_DIRECTOR

Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

Benedikt A Jonsson, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

Geir Hallan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

Ove Furnes, MD, PhD

Role: STUDY_CHAIR

Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

Clara G Gjesdal, MD, PhD

Role: STUDY_CHAIR

Department of Rheumatology, Haukeland University Hospital, Bergen, Norway

Kristin Haugan, MA

Role: STUDY_CHAIR

Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway

Arne K Skredderstuen, MD

Role: STUDY_CHAIR

Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

Terje Stokke

Role: STUDY_CHAIR

Department of Radiology, Haukeland University Hospital, Bergen, Norway

Locations

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Department of Orthopaedic Surgery, Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2011/133

Identifier Type: -

Identifier Source: org_study_id

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