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

1129-18-VS (SP-DT)A clinical study to check whether the proposed patient specific instrument (X-ray based PSI) developed using X-ray based 3D planning software performs equivalent to conventional instrument, to achieve accurate post-operative lower-limb mechanical axis alignment; for total knee replacement (TKR) surgery

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015818

Enrollment

Registered

2018-09-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: X-ray based patient specific instrument for Total Knee arthroplasty: Patient Specific instruments developed using X-rays of patient used for getting the virtual cutting alignment, and

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactManu Sankar M

Algosurg Products Pvt Ltd

vikas@algosurg.com9920674982

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026