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Trial record 18 of 2573 for:    Arthroplasty

Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03692364
Recruitment Status : Active, not recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Per-Erik Johanson, Sahlgrenska University Hospital, Sweden

Brief Summary:
Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.

Condition or disease Intervention/treatment Phase
Arthroplasty Complications Device: Ceramic-on-ceramic uncemented hip arthroplasty Device: Metal-on-polyethylene uncemented total hip arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients
Actual Study Start Date : October 2, 2003
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metal-on-conventional polyethylene
Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a CoCr prosthetic femoral head and an acetabular liner made of intermedially cross-linked polyethylene polyethylene (Duration, Stryker, Mahwah, NJ, US).
Device: Metal-on-polyethylene uncemented total hip arthroplasty
Experimental: Ceramic-on-ceramic
Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a prosthetic femoral head and an acetabular liner made of alumina ceramic (Biolox Forte, Ceramtec, Plochingen, Germany).
Device: Ceramic-on-ceramic uncemented hip arthroplasty



Primary Outcome Measures :
  1. Osteolysis frequency change between 7 and 15 years [ Time Frame: Change between 7 to 15 years after surgery ]
    Osteolysis frequency (%) measured with computed tomography,

  2. Osteolysis size change between 7 and 15 years [ Time Frame: Change between 7 and 15 years after surgery ]
    Osteolysis size (cm3) measured with computed tomography


Secondary Outcome Measures :
  1. Articulation wear at 7 years [ Time Frame: At 7 years after surgery ]
    Articulation wear as measured with radiostereometry, mm/year

  2. Articulation wear at 15 years [ Time Frame: 15 years after surgery ]
    Articulation wear as measured with radiostereometry, mm/year

  3. Implant fixation at 7 years [ Time Frame: 7 years after surgery ]
    Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry

  4. Implant fixation at 15 years [ Time Frame: At 15 years after surgery ]
    Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry

  5. Clinical function at 7 years [ Time Frame: 7 years after surgery ]
    Harris Hip Score (0-100)

  6. Clinical function at 15 years [ Time Frame: 15 years after surgery ]
    Harris Hip Score (0-100)



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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary osteoarthritis
  • secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)

Exclusion Criteria:

  • inflammatory arthritis
  • hip joint infection

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Responsible Party: Per-Erik Johanson, Researcher, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03692364     History of Changes
Other Study ID Numbers: Protesteam_ceram
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Per-Erik Johanson, Sahlgrenska University Hospital, Sweden:
biomaterials
Implant wear
hip arthroplasty
osteolysis
aseptic loosening