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Prospective Randomised Study of a New an Uncemented Stem.

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hip Arthroplasty
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip arthroplasty, Joint replacement, Uncemented stem, Anatomical stem

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary osteoartritis Secondary osteoartritis

Exclusion Criteria:

  • Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    SP-CL

    Corail

    Arm Description

    Outcomes

    Primary Outcome Measures

    Oxford hip score
    Patient reported outcome measure

    Secondary Outcome Measures

    RSA-examination
    Migration of stem
    Conventional X-rays
    Detection of radiolucent lines
    Harris hip score
    Patient reported outcome
    DXA
    Change of bone mineral density

    Full Information

    First Posted
    October 13, 2020
    Last Updated
    October 19, 2020
    Sponsor
    Sahlgrenska University Hospital, Sweden
    Collaborators
    Link America, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04599582
    Brief Title
    Prospective Randomised Study of a New an Uncemented Stem.
    Official Title
    Prospective Randomised Study of a New Anteverted Uncemented Stem. Randomised Study Between the SP-CL and the Corail Stem With the Use of a Delta Cup.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    May 31, 2019 (Actual)
    Study Completion Date
    May 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sahlgrenska University Hospital, Sweden
    Collaborators
    Link America, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will be done at two years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Osteoarthritis
    Keywords
    hip arthroplasty, Joint replacement, Uncemented stem, Anatomical stem

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SP-CL
    Arm Type
    Active Comparator
    Arm Title
    Corail
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Hip Arthroplasty
    Intervention Description
    Patients are operated with hip replacement.
    Primary Outcome Measure Information:
    Title
    Oxford hip score
    Description
    Patient reported outcome measure
    Time Frame
    two years
    Secondary Outcome Measure Information:
    Title
    RSA-examination
    Description
    Migration of stem
    Time Frame
    two years
    Title
    Conventional X-rays
    Description
    Detection of radiolucent lines
    Time Frame
    two years
    Title
    Harris hip score
    Description
    Patient reported outcome
    Time Frame
    two years
    Title
    DXA
    Description
    Change of bone mineral density
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary osteoartritis Secondary osteoartritis Exclusion Criteria: Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prospective Randomised Study of a New an Uncemented Stem.

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