Post Marketing Surveillance Study to Evaluate the Survivorship and Performance of the LatitudTM Hip Replacement System in Subjects Requiring a Hip Replacement.

LatitudTM 180: A Prospective, Multi-Centre, Observational, Post Marketing Surveillance Study to Evaluate the Survivorship and Performance of the LatitudTM Hip Replacement System in Subjects Requiring a Hip Replacement. - LatitudTM 180

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/06/008774

Enrollment

180

Registered

2017-06-07

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: M169- Osteoarthritis of hip, unspecified Health Condition 2: M169- Osteoarthritis of hip, unspecified

Interventions

Intervention1: LatitudTM Hip Replacement System: LatitudTM Hip Replacement System is a system of different components intended to replace hip joint. The components are available in different design/st

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject is male or non-pregnant female age 18 years or older at the time of study. 2. Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form. 3. Subject is a candidate for a total hip replacement. 4. Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations

Exclusion criteria

Exclusion criteria: 1. Subject with a BMI greater than or equal to 40. 2. Subject with an active infection within the affected hip joint. 3. Subject with neuromuscular or neurosensory deficiency that may limit ability of the patient to evaluate the safety and efficacy of the device. 4. Subject with a known sensitivity to device materials 5. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. 6. Subject is unwilling or unable to sing the Informed Consent Document. 7. Subject with short Life expectancy less than 5 years (e.g. Cancer, HIV/AIDS) 8. Subject with history of deep vein thrombosis or other thrombotic disorders. 9. Subjects for whom the surgical procedure is a revision of a previous THR or hemi-arthroplasty, or who have previously undergone arthrodesis or osteotomy of the hip. 10. Subject who, in consideration of treating doctor, would not be suitable for compliance of the follow-up

Design outcomes

Primary

Measure	Time frame
1.Implant Survivorship 2.Performance of Implant 3.Cumulative Revision Rate Timepoint: 6weeksÂ± 15 days, 6 monthsÂ± 28 days, 1yrÂ± 28 days, 2yrsÂ± 28 days, 5yrsÂ± 28 days, 7yrsÂ± 28 days, 10yrsÂ± 28 days	—

Secondary

Measure	Time frame
1. Harris Hip Score 2. Radiographic analysis 3. Oxford Hip Score 4. Adverse EventsTimepoint: Pre-Operative & 6weeksÂ± 15 days, 6 monthsÂ± 28 days, 1yrÂ± 28 days, 2yrsÂ± 28 days, 5yrsÂ± 28 days, 7yrsÂ± 28 days, 10yrsÂ± 28 days	—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Apollo Gleneagles Hospitals

kanta_chatterjee@yahoo.com9831516279

Outcome results

None listed

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