Performance Trial of Algosurg X-ray based Patient Specific Instrument for Total Knee replacement surgery

Phase 1

Conditions: Health Condition 1: null- Patients with primary osteoarthritis condition undergoing Total knee replacement surgery

Registration Number: CTRI/2018/09/015818

Lead Sponsor: Algosurg Products Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male or female aged greater than 45 years

2. Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty

3. Able to understand what participation in the study entails and willing to consent (patient or his/her legal guardian) to participate in the study by signing and dating an IRB/EC approved informed consent form

4. Able and willing to undergo a preoperative and intraoperative imaging (X-ray, CT)

5. Should not have any other deformity in the leg to be operated

6. Approve the fitting / placement of X-ray based PSI on the exposed surface of the bone intraoperatively

Exclusion Criteria

1. Is currently enrolled in an investigational new drug or device study

2. Has had a prior ipsilateral uni-compartmental knee arthroplasty, TKA, knee fusion or patellectomy

3. Have indications of intra- and/or extra-articular deformations that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, such as polio, history of Tibial plateau fracture, etc.

4. Has arterial disease or stents that would exclude the use of a tourniquet

5. Has a mental condition that may interfere with his/her ability to give an informed consent or interfere with his/her ability or willingness to fulfil the requirements of the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MAD: The distance between the mechanical axis line (Total Limb) and the centre of the knee in the frontal plane is the MAD. <br/ ><br>- Good: If the distance between the Mechanical axis of the limb and the centre of the Knee is â?¤ 5% of the condyle width <br/ ><br>- Moderate: If the distance between the Mechanical axis of the limb and the centre of the Knee is 5% â?¤ 10% of the condyle width <br/ ><br>- Bad: above 10 % of condyle width <br/ ><br>Timepoint: day 2

Secondary Outcome Measures

Name	Time	Method
Hip â?? Knee â?? Ankle angle of the leg (mechanical axis of full leg)Timepoint: Day 2;Lateral distal femoral angle (mLDFA)Timepoint: Day 2;Medial proximal Tibial angle (mPTA)Timepoint: Day 2 <br/ ><br>