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SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty

Primary Purpose

Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bone cement 1
Bone cement 2
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring total hip arthroplasty, Charnley stem, RSA, non-inflammatory arthritis

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients in need for total hip arthroplasty

Exclusion Criteria:

  • patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips),
  • patients on corticosteroid treatment,
  • patients who had already participated in a clinical study with an investigational product in the last 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Distal migration of the charnley femoral stem

    Secondary Outcome Measures

    Rotational movements of the charnley femoral stem

    Full Information

    First Posted
    February 4, 2009
    Last Updated
    August 25, 2011
    Sponsor
    Norwegian University of Science and Technology
    Collaborators
    DePuy International
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00837850
    Brief Title
    SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty
    Official Title
    A Randomised Prospective Trial of SmartSet HV and Palacos R Bone Cements in Primary Total Hip Arthroplasty. A Radiostereometric Analysis of the Charnley Femoral Component.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    October 2003 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology
    Collaborators
    DePuy International

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.
    Detailed Description
    The fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. Bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. However, there are significant differences in cement behaviour among differing types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity. Studies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. RSA is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis
    Keywords
    total hip arthroplasty, Charnley stem, RSA, non-inflammatory arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Title
    2
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Bone cement 1
    Other Intervention Name(s)
    SmartSet HV
    Intervention Description
    Bone cement SmartSet® HV
    Intervention Type
    Device
    Intervention Name(s)
    Bone cement 2
    Other Intervention Name(s)
    Palacos R
    Intervention Description
    Bone cement Palacos R
    Primary Outcome Measure Information:
    Title
    Distal migration of the charnley femoral stem
    Time Frame
    2010
    Secondary Outcome Measure Information:
    Title
    Rotational movements of the charnley femoral stem
    Time Frame
    2010

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients in need for total hip arthroplasty Exclusion Criteria: patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips), patients on corticosteroid treatment, patients who had already participated in a clinical study with an investigational product in the last 6 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Otto S. Husby, PhD
    Organizational Affiliation
    St.Olavs hospital HF
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20198403
    Citation
    Husby OS, Haugan K, Benum P, Foss OA. A prospective randomised radiostereometric analysis trial of SmartSet HV and Palacos R bone cements in primary total hip arthroplasty. J Orthop Traumatol. 2010 Mar;11(1):29-35. doi: 10.1007/s10195-010-0087-x. Epub 2010 Mar 3.
    Results Reference
    result

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    SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty

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