Comparison of outcomes in total knee replacement done with help of computer navigation guided and robotic arm assisted technology.

Not Applicable

Completed

• Conditions: Health Condition 1: M171- Unilateral primary osteoarthritisof knee

• Registration Number: CTRI/2020/01/022870
• Lead Sponsor: Fortis Escorts Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-01-18
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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)

11.Subject is pregnant or plans to become pregnant during the study.

12.Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse.

13.Subject has a BMI >40.

14.Subject is enrolled in another investigational drug, biologic, or device study.

15.Subject is facing current or impending incarceration.

16.Subject has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional - <br/ ><br>Knee Society Score (KSS) <br/ ><br>Knee Society Function Score (KSFS) <br/ ><br>Knee Injury and Osteoarthritis Outcomes Score (KOOS) <br/ ><br>High Flexion Knee Score (HFKS) <br/ ><br>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) <br/ ><br>Visual Analogue Scale (VAS) <br/ ><br>Radiological ââ?¬â?? <br/ ><br>Coronal Tibial angle <br/ ><br>Coronal Femoral angle <br/ ><br>Hip Knee Ankle axis <br/ ><br>Joint line <br/ ><br>Patellar thickness <br/ ><br>Anterior offset <br/ ><br>Posterior offset <br/ ><br>Femoral flexion angle <br/ ><br>Femoral rotational angle <br/ ><br>Timepoint: 2YEARS

Secondary Outcome Measures

Name	Time	Method
Complications <br/ ><br>Hospital stay <br/ ><br>Blood loss <br/ ><br>Tourniquet time <br/ ><br>Registration time <br/ ><br>Timepoint: 2YEARS