Cemented Marathon/Corail Versus Pinnacle/Corail

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01693627
First received: March 21, 2012
Last updated: July 7, 2013
Last verified: July 2013
  Purpose

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

Condition Intervention
Arthritis of the Hip
Device: Pinnacle/Corail with collar
Device: Marathon/Corail with collar
Device: Pinnacle/Corail without collar
Device: Marathon/Corail without collar

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Polyethylene wear [ Time Frame: After 5 years of follow-up ] [ Designated as safety issue: No ]
    Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis

  • Component migration-cup [ Time Frame: After 5 years of follow-up ] [ Designated as safety issue: No ]
    Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.

  • Periprosthetic bone mineral density [ Time Frame: After 2 years of follow-up ] [ Designated as safety issue: No ]
    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.

  • Component migration-stem [ Time Frame: After 5 years of follow-up ] [ Designated as safety issue: No ]
    Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: After 5 years of follow-up ] [ Designated as safety issue: No ]
    Comparison of clinical results between study groups using HHS and PROMs


Estimated Enrollment: 48
Study Start Date: January 2012
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693627

Contacts
Contact: Benedikt A Jonsson, MD +47 55 97 56 37 benedikt.arni.jonsson@helse-bergen.no
Contact: Geir Hallan, MD PHD geir.hallan@helse-bergen.no

Locations
Norway
Department of Orthopaedic Surgery, Haukeland University Hospital Recruiting
Bergen, Norway, 5096
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Director: Leif I Havelin, MD, PhD Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Principal Investigator: Benedikt A Jonsson, MD Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Principal Investigator: Geir Hallan, MD, PhD Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Study Chair: Ove Furnes, MD, PhD Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Study Chair: Clara G Gjesdal, MD, PhD Department of Rheumatology, Haukeland University Hospital, Bergen, Norway
Study Chair: Kristin Haugan, MA Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway
Study Chair: Arne K Skredderstuen, MD Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Study Chair: Terje Stokke Department of Radiology, Haukeland University Hospital, Bergen, Norway
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01693627     History of Changes
Other Study ID Numbers: 2011/133
Study First Received: March 21, 2012
Last Updated: July 7, 2013
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014