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Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty (MIS)

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
surgery method using CR TKP
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

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

Inclusion Criteria:

  • patient requiring Total Knee Arthroplasty (TKA)
  • patients with Osteo arthritis
  • intact collateral ligaments and patella tendon
  • patients willing and able to comply with the post-operative schedule

Exclusion Criteria:

  • patients who require a revision TKA
  • patients with TKA contralateral knee within 6 months with bad outcomes
  • patients who need a TKA on contralateral side within 2 years
  • intraoperative resurfacing of patella
  • intraoperative eversion of patella
  • patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy
  • BMI > 30
  • patients with fixed flexion contracture> 15 degrees
  • patients with deformity greater than 20 degrees of varus or 15 degrees of valgus
  • Patient with Mediolateral stability > 10 degrees patient with active or suspected malignancy
  • patient with Rheumatoid arthritis
  • patient with systemic disease that would effect subject's wellfare or overall outcome of the study
  • patient with other severe concurrent joint involvement which can effect their outcome
  • patients with an immobile hip
  • patient with a history of Pulmonary embolism or Deep venous thrombosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MIS

    conventional approach

    Arm Description

    Minimal invasive surgery for placement total knee prosthesis

    conventional "open" surgery for placement total knee prosthesis.

    Outcomes

    Primary Outcome Measures

    range of motion
    measurement of flexion and extension in degrees
    blood loss
    measurement of milliliters blood loss during the first 24 hours after surgery

    Secondary Outcome Measures

    patient questionnaire
    WOMAC pain and function score
    chair rise and stair climb test
    Ability of patient rise from chair and climb stairs, amount of pain on VAS 1-10 does the patient have during these activities

    Full Information

    First Posted
    November 30, 2015
    Last Updated
    December 8, 2015
    Sponsor
    Maastricht University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02625311
    Brief Title
    Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty
    Acronym
    MIS
    Official Title
    A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maastricht University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis. Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.
    Detailed Description
    Study executed with 3 centers and 69 patients.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MIS
    Arm Type
    Experimental
    Arm Description
    Minimal invasive surgery for placement total knee prosthesis
    Arm Title
    conventional approach
    Arm Type
    Active Comparator
    Arm Description
    conventional "open" surgery for placement total knee prosthesis.
    Intervention Type
    Procedure
    Intervention Name(s)
    surgery method using CR TKP
    Other Intervention Name(s)
    Cruciate retaining (CR total knee prosthesis (TKP) Stryker
    Intervention Description
    Operation through minimal invasive surgery or standard open surgery
    Primary Outcome Measure Information:
    Title
    range of motion
    Description
    measurement of flexion and extension in degrees
    Time Frame
    pre-op vs post-op until 5 years post-op
    Title
    blood loss
    Description
    measurement of milliliters blood loss during the first 24 hours after surgery
    Time Frame
    24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    patient questionnaire
    Description
    WOMAC pain and function score
    Time Frame
    pre-op vs post-op until 5 year post operative
    Title
    chair rise and stair climb test
    Description
    Ability of patient rise from chair and climb stairs, amount of pain on VAS 1-10 does the patient have during these activities
    Time Frame
    pre-op vs post-op until 5 years post operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient requiring Total Knee Arthroplasty (TKA) patients with Osteo arthritis intact collateral ligaments and patella tendon patients willing and able to comply with the post-operative schedule Exclusion Criteria: patients who require a revision TKA patients with TKA contralateral knee within 6 months with bad outcomes patients who need a TKA on contralateral side within 2 years intraoperative resurfacing of patella intraoperative eversion of patella patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy BMI > 30 patients with fixed flexion contracture> 15 degrees patients with deformity greater than 20 degrees of varus or 15 degrees of valgus Patient with Mediolateral stability > 10 degrees patient with active or suspected malignancy patient with Rheumatoid arthritis patient with systemic disease that would effect subject's wellfare or overall outcome of the study patient with other severe concurrent joint involvement which can effect their outcome patients with an immobile hip patient with a history of Pulmonary embolism or Deep venous thrombosis

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26762175
    Citation
    Feczko P, Engelmann L, Arts JJ, Campbell D. Computer-assisted total knee arthroplasty using mini midvastus or medial parapatellar approach technique: A prospective, randomized, international multicentre trial. BMC Musculoskelet Disord. 2016 Jan 13;17:19. doi: 10.1186/s12891-016-0872-7.
    Results Reference
    derived

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