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Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT02196792
Recruitment Status : Active, not recruiting
First Posted : July 22, 2014
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Kristian Kjærgaard, Odense University Hospital

Brief Summary:
The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Osteoarthritis Device: E-Poly liner Device: ArComXL liner Device: 32 mm femoral head Device: 36 mm femoral head Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial
Study Start Date : May 1, 2009
Actual Primary Completion Date : May 1, 2015
Estimated Study Completion Date : May 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: E-Poly/32 mm
E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.
Device: E-Poly liner
E-Poly liner with a titanium cup

Device: 32 mm femoral head
Stem with a 32 mm CoCr femoral head

Active Comparator: E-Poly/36 mm
E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
Device: E-Poly liner
E-Poly liner with a titanium cup

Device: 36 mm femoral head
Stem with a 36 mm CoCr femoral head

Active Comparator: ArComXL/32 mm
ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.
Device: ArComXL liner
ArComXL liner with a titanium cup

Device: 32 mm femoral head
Stem with a 32 mm CoCr femoral head

Active Comparator: ArComXL/36 mm
ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
Device: ArComXL liner
ArComXL liner with a titanium cup

Device: 36 mm femoral head
Stem with a 36 mm CoCr femoral head




Primary Outcome Measures :
  1. Mean head penetration from baseline to 5 year follow-up [ Time Frame: From baseline to 5 years ]
    Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up


Secondary Outcome Measures :
  1. Mean cup migration form baseline to 5 year follow-up [ Time Frame: From baseline to 5 years ]
    Mean cup migration assessed using RSA from baseline to 5 year follow-up

  2. Mean change in clinical outcome score from baseline to 5 year follow-up [ Time Frame: From baseline to 5 years ]
    Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary idiopathic arthritis,
  • Eligible for uncemented total hip arthroplasty
  • 40 to70 years of age,
  • Cup size of 54mm and above

Exclusion Criteria:

  • Anteversion where non-standard stem can be used,
  • Dysplasia (Center-edge angle of Wiberg < 20°),
  • Malignant condition
  • Prior radiotherapy
  • Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
  • Complications during surgery (requiring screws in shell or femoral cerclage)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196792


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Massachusetts General Hospital
Investigators
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Principal Investigator: Kristian Kjærgaard, BSc.med Odense University Hospital, University of Southern Denmark
Study Director: Søren Overgaard, Professor, MD Odense University Hospital, University of Southern Denmark
  Study Documents (Full-Text)

Documents provided by Kristian Kjærgaard, Odense University Hospital:
Statistical Analysis Plan  [PDF] March 19, 2018


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Responsible Party: Kristian Kjærgaard, Research assistant, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02196792     History of Changes
Other Study ID Numbers: project-ID S-20080151
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kristian Kjærgaard, Odense University Hospital:
Joint Diseases
Musculoskeletal Diseases
radiostereometric analysis
Total hip arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases