Cemented Marathon/Corail Versus Pinnacle/Corail

Arthritis of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01693627
• Other study ID #: 2011/133
• Status: Active, not recruiting
• Phase: N/A
• First received: March 21, 2012
• Last updated: February 23, 2016
• Start date: January 2012
• Est. completion date: January 2022

Study information

• Verified date: February 2016
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: January 2022
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis of the Hip

Intervention

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.
• 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 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
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.

Locations

Country	Name	City	State
Norway	Department of Orthopaedic Surgery, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyethylene wear	Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis	After 5 years of follow-up	No
Primary	Component migration-cup	Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.	After 5 years of follow-up	No
Primary	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.	After 2 years of follow-up	No
Primary	Component migration-stem	Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.	After 5 years of follow-up	No
Secondary	Clinical outcome	Comparison of clinical results between study groups using HHS and PROMs	After 5 years of follow-up	No