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Clinical Trials/CTRI/2020/01/022870
CTRI/2020/01/022870
Completed
未知

Comparison of functional and radiological outcomes of total knee arthroplasty performed by robotic arm and computer navigation. A prospective randomized study

Fortis Escorts Hospital0 sites100 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Sponsor
Fortis Escorts Hospital
Enrollment
100
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
January 18, 2021
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.Subject is a candidate for unilateral primary total knee arthroplasty due to degenerative joint disease.
  • 2\.Subject is willing to sign and date an EC\-approved consent form.
  • 3\.Subject is male or female between the ages of 35 and 75 years of age.
  • 4\.Subject plans to be available through 2 years post\-operative follow\-up.
  • 5\.Subject agrees to follow the study protocol.

Exclusion Criteria

  • 1\.Subject having deformity more than 20 degree in coronal and sagittal plane.
  • 2\.Subject having history of revision knee for a previously failed total or unicondylar knee arthroplasty.
  • 3\.Subject has a history of patellar fracture, patellectomy, patello\-femoral instability or high tibial osteotomy.
  • 4\.Subject having any extra\-articular bony deformity in lower limbs.
  • 5\.Subject has inflammatory arthritis.
  • 6\.Subject possesses a contralateral or ipsilateral revision hip arthroplasty
  • 7\.Subject has ipsilateral hip arthritis resulting in flexion contracture
  • 8\.Subject has an active infection or sepsis (treated or untreated) or presence of malignant tumor , either primary or metastatic, or benign tumor on leg with knee to be treated
  • 9\.Subject has conditions that may interfere with the TKA survival or outcome (e.g. Pagetââ?¬•s or Charcotââ?¬•s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes mellitus i.e. not under treatment with oral/injectable medications to control blood glucose levels, fibromyalgia, moderate to severe renal insufficiency or neuromuscular disease)
  • 10\.Subject has lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture)

Outcomes

Primary Outcomes

Not specified

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