Cemented Marathon/Corail Versus Pinnacle/Corail

Not Applicable

• Conditions: Arthritis of the Hip
• Interventions: Device: Marathon/Corail with collar; Device: Pinnacle/Corail with collar; Device: Pinnacle/Corail without collar; Device: Marathon/Corail without collar

• 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

Arm && Interventions

Group	Intervention	Description
Marathon/Corail with collar	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.
Pinnacle/Corail with collar	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.
Pinnacle/Corail without collar	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.
Marathon/Corail without collar	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.

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