Cemented Marathon/Corail Versus Pinnacle/Corail

Haukeland University Hospital

Status: Unknown

Conditions: Arthritis of the Hip

Treatments: Device: Pinnacle/Corail without collar; Device: Pinnacle/Corail with collar; Device: Marathon/Corail with collar; Device: Marathon/Corail without collar

Study type: Interventional

Funder types: Other

Identifiers

NCT01693627

2011/133

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 4 patient groups

Pinnacle/Corail with collar

Active Comparator group

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.

Treatment:

Device: Pinnacle/Corail with collar

Marathon/Corail with collar

Active Comparator group

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.

Treatment:

Device: Marathon/Corail with collar

Pinnacle/Corail without collar

Active Comparator group

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.

Treatment:

Device: Pinnacle/Corail without collar

Marathon/Corail without collar

Active Comparator group

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.

Treatment:

Device: Marathon/Corail without collar