NCT01693627

Cemented Marathon/Corail Versus Pinnacle/Corail

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-01-01
• Completion: 2022-01-01
• First posted: 2012-09-26
• Last updated: 2016-02-24

Locations

1 site across 1 country: Norway