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The Results of Oxford Unicompartmental Knee Arthroplasty in Patients With and Without Preoperative Genu Recurvatum

Primary Purpose

Primary Gonarthrosis, Genu Recurvatum

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxford unicompartmental knee arthroplasty
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Gonarthrosis

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The medial OA knee with older than 40 years of age, ROM greater than 90°, varus deformity less than 25°, and flexion contractures less than 20°

Exclusion Criteria:

  • patients who were diagnosed spontaneous osteonecrosis of knee (SPONK), patients with intraoperative ACL insufficiency, post traumatic arthritis, gouty arthritis, inflammatory joints.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    patients with genu recurvatum

    patients without genu recurvatum

    Arm Description

    The medial osteoarthritis knees with genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded.

    The medial osteoarthritis knees without genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded.

    Outcomes

    Primary Outcome Measures

    hyperextension angle, the incidence of postoperative genu recurvatum
    hyperextension angle, the incidence of postoperative genu recurvatum

    Secondary Outcome Measures

    Full Information

    First Posted
    June 6, 2016
    Last Updated
    June 1, 2020
    Sponsor
    Thammasat University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02854189
    Brief Title
    The Results of Oxford Unicompartmental Knee Arthroplasty in Patients With and Without Preoperative Genu Recurvatum
    Official Title
    Department of Orthopaedics Faculty of Medicine Thammasat University Thailand
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Thammasat University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to explore the effects of the Oxford unicompartmental knee arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure and one without. Specifically, this study compare the number of occurrences of postoperative genu recurvatum and the postoperative hyperextension angles among the patients. Additionally, the knee scores, the pain scores, and the functional scores for the two groups of patients are compared. Materials and methods: This study prospectively followed 104 patients (114 knees) who had been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up. The patients were divided into two groups: those without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the postoperative hyperextension angles, the knee scores, the pain scores, and the functional scores were recorded and compared between two groups..
    Detailed Description
    The patients in both groups were applied with cemented Oxford unicompartmental knee arthroplasty with the same surgeon. The all patients were performed surgery with minimally invasive surgery technique. The gender, site, range of motion, alignment of prosthesis, operative time, blood loss, and posterior slope of tibial component also were recorded and compared between two groups. The incidence of postoperative genu recurvatum, gender, and site were computed using Fisher's exact test. The hyperextension angle, knee score, pain score, functional score,range of motion, alignment of prosthesis, posterior slope of tibial component, operative time, and blood loss were compared with student t-test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Gonarthrosis, Genu Recurvatum

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with genu recurvatum
    Arm Type
    Other
    Arm Description
    The medial osteoarthritis knees with genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded.
    Arm Title
    patients without genu recurvatum
    Arm Type
    Other
    Arm Description
    The medial osteoarthritis knees without genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded.
    Intervention Type
    Device
    Intervention Name(s)
    Oxford unicompartmental knee arthroplasty
    Intervention Description
    The Oxford unicompartmental knee arthroplasty was applied in all patients with medial osteoarthritis knee.The Oxford unicompartmental knee arthroplasty is mobile bearing unicompartmental knee arthroplasty.
    Primary Outcome Measure Information:
    Title
    hyperextension angle, the incidence of postoperative genu recurvatum
    Description
    hyperextension angle, the incidence of postoperative genu recurvatum
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The medial OA knee with older than 40 years of age, ROM greater than 90°, varus deformity less than 25°, and flexion contractures less than 20° Exclusion Criteria: patients who were diagnosed spontaneous osteonecrosis of knee (SPONK), patients with intraoperative ACL insufficiency, post traumatic arthritis, gouty arthritis, inflammatory joints.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Results of Oxford Unicompartmental Knee Arthroplasty in Patients With and Without Preoperative Genu Recurvatum

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