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Comparison of Oxford UKA and Sigma UKA With RSA.

Primary Purpose

Knee Osteoarthritis, Knee Replacement, RSA

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxford UKA vs Sigma UKA
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • All eligable patients with medial osteoarthritis of the knee.

Exclusion Criteria:

  • - Inflammatory arthritis.
  • Patients who are not able to participate in the fast-track surgery program.
  • Patients with a contralateral knee arthroplasty.
  • Patients who are unable to provide informed consent.
  • Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy.
  • Serious systemic disease (e.g.. hemiparesis and severe parkinsonism)
  • On-going case involving work injury of the knee.
  • Female patients with a wish of becoming pregnant in the study period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Oxford

    Sigma

    Arm Description

    Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department.

    Patients receiving a Sigma UKA, which is the experimental treatment.

    Outcomes

    Primary Outcome Measures

    Migration of prosthesis
    RSA

    Secondary Outcome Measures

    Bone mineral density
    DXA
    Polyethylene wear
    Weight-bearing RSA

    Full Information

    First Posted
    February 9, 2018
    Last Updated
    May 16, 2019
    Sponsor
    Regional Hospital Holstebro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03434600
    Brief Title
    Comparison of Oxford UKA and Sigma UKA With RSA.
    Official Title
    Comparison of the Oxford Unicompartmental Knee Prosthesis With the Sigma High Performance Partial Knee Using Rontgen Stereophotogrammetric Analysis in Patients With Primary Medial Unicompartmental Knee Osteoarthritis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (Actual)
    Primary Completion Date
    November 2017 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Regional Hospital Holstebro

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Finally, the functional outcome after surgery is compared between the two arthroplasties. Hypothesis: H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up. H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years. H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and leg extension power (LEP) postoperative. H4: BMD of the proximal tibia does not influence migration of the tibial component

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Knee Replacement, RSA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oxford
    Arm Type
    Active Comparator
    Arm Description
    Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department.
    Arm Title
    Sigma
    Arm Type
    Experimental
    Arm Description
    Patients receiving a Sigma UKA, which is the experimental treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Oxford UKA vs Sigma UKA
    Primary Outcome Measure Information:
    Title
    Migration of prosthesis
    Description
    RSA
    Time Frame
    2 years follow-up
    Secondary Outcome Measure Information:
    Title
    Bone mineral density
    Description
    DXA
    Time Frame
    2 years follow-up
    Title
    Polyethylene wear
    Description
    Weight-bearing RSA
    Time Frame
    5 years follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All eligable patients with medial osteoarthritis of the knee. Exclusion Criteria: - Inflammatory arthritis. Patients who are not able to participate in the fast-track surgery program. Patients with a contralateral knee arthroplasty. Patients who are unable to provide informed consent. Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy. Serious systemic disease (e.g.. hemiparesis and severe parkinsonism) On-going case involving work injury of the knee. Female patients with a wish of becoming pregnant in the study period.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daan Koppens
    Organizational Affiliation
    Hospital Unit Vest
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of Oxford UKA and Sigma UKA With RSA.

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