Cemented Marathon/Corail Versus Pinnacle/Corail

Haukeland University Hospital61 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Arthritis of the Hip

Interventions

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 collarDEVICE

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 collarDEVICE

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 collarDEVICE

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Orthopaedic Surgery, Haukeland University Hospital

Bergen, Norway

Outcomes

Primary Outcomes

Polyethylene wear

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

Component migration-cup

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

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.

Time frame: After 2 years of follow-up

Component migration-stem

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 Outcomes

Clinical outcome

Comparison of clinical results between study groups using HHS and PROMs

Time frame: After 5 years of follow-up

Data from ClinicalTrials.gov

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