Cemented Marathon/Corail Versus Pinnacle/Corail

Not Applicable

• Conditions: Arthritis of the Hip

• Registration Number: NCT01693627
• Lead Sponsor: Haukeland University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24
• Primary Completion: 2017-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Component migration-cup	After 5 years of follow-up	Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.
Component migration-stem	After 5 years of follow-up	Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.
Polyethylene wear	After 5 years of follow-up	Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis
Periprosthetic bone mineral density	After 2 years of follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Clinical outcome	After 5 years of follow-up	Comparison of clinical results between study groups using HHS and PROMs

Trial Locations

Locations (1)

Department of Orthopaedic Surgery, Haukeland University Hospital; 🇳🇴 Bergen, Norway