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Cemented Marathon/Corail Versus Pinnacle/Corail

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01693627
Recruitment Status : Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE March 21, 2012
First Posted Date  ICMJE September 26, 2012
Last Update Posted Date February 24, 2016
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
  • Polyethylene wear [ Time Frame: 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
  • Component migration-cup [ Time Frame: 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.
  • Periprosthetic bone mineral density [ Time Frame: 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.
  • Component migration-stem [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2012)
Clinical outcome [ Time Frame: After 5 years of follow-up ]
Comparison of clinical results between study groups using HHS and PROMs
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
Clinical outcome [ Time Frame: After 5 years of follow-up ]
Comparison of clinical results between study groups using Harris Hip Score, Visual Analog Scale and EQ5D.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cemented Marathon/Corail Versus Pinnacle/Corail
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Arthritis of the Hip
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Pinnacle/Corail with collar
  • 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.
    Intervention: Device: Marathon/Corail with collar
  • 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.
    Intervention: Device: Pinnacle/Corail without collar
  • 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.
    Intervention: Device: Marathon/Corail without collar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 23, 2016)
61
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2012)
48
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01693627
Other Study ID Numbers  ICMJE 2011/133
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Haukeland University Hospital
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP