Clinical trial NCT01693627: Cemented Marathon/Corail Versus Pinnacle/Corail
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthritis of the Hip
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Polyethylene wear
timeFrame: After 5 years of follow-up
measure: Component migration-cup
timeFrame: After 5 years of follow-up
measure: Periprosthetic bone mineral density
timeFrame: After 2 years of follow-up
measure: Component migration-stem
timeFrame: After 5 years of follow-up
Secondary outcomes:
measure: Clinical outcome
timeFrame: After 5 years of follow-up
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Orthopaedic Surgery, Haukeland University Hospital
Study officials:
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
name: Leif I Havelin, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
name: Benedikt A Jonsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
name: Geir Hallan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
name: Ove Furnes, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Rheumatology, Haukeland University Hospital, Bergen, Norway
name: Clara G Gjesdal, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway
name: Kristin Haugan, MA
role: STUDY_CHAIR
affiliation: Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
name: Arne K Skredderstuen, MD
role: STUDY_CHAIR
affiliation: Department of Radiology, Haukeland University Hospital, Bergen, Norway
name: Terje Stokke
role: STUDY_CHAIR
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