Cemented Marathon/Corail Versus Pinnacle/Corail

Summary

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

Conditions

• Arthritis of the Hip

Interventions

DEVICE

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.

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.

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.

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.

Sponsors & Collaborators

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Leif I Havelin, MD, PhD · Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

• Benedikt A Jonsson, MD · Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

• Geir Hallan, MD, PhD · Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

• Ove Furnes, MD, PhD · Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

• Clara G Gjesdal, MD, PhD · Department of Rheumatology, Haukeland University Hospital, Bergen, Norway

• Kristin Haugan, MA · Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway

• Arne K Skredderstuen, MD · Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway

• Terje Stokke · Department of Radiology, Haukeland University Hospital, Bergen, Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2017-01-31

Completion

2022-01-31

Countries

• Norway

Study Locations