| CTRI Number |
CTRI/2025/04/085046 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Post-Market Clinical follow-up study to evaluate safety and performance of Altius Buechel Pappas Primary Total Knee Replacement System |
|
Scientific Title of Study
|
An open-label, prospective, single centric, non-comparative, observational, Post-Market Clinical Follow-up to evaluate the safety and effectiveness of AltiusTM Buechel Pappas High Flex Total Knee Replacement System in Adult subject for a period of 15 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aashish Chaudhry |
| Designation |
Principal Investigator |
| Affiliation |
Aakash Healthcare Super Speciality Hospital |
| Address |
Aakash Healthcare Super Specialty Hospital,
Hospital Plot, Road No.201, Sector-3, Dwarka, New Delhi-110075,
Department: Orthopedics
Division: Unit-I
Room No.: 05, Ground Floor OPD
Phone: 011 43388888
New Delhi
DELHI
110075
India |
| Phone |
01143388888 |
| Fax |
|
| Email |
anjusha.singh@aakashhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aashish Chaudhry |
| Designation |
Principal Investigator |
| Affiliation |
Aakash Healthcare Super Speciality Hospital |
| Address |
Aakash Healthcare Super Specialty Hospital,
Hospital Plot, Road No.201, Sector-3, Dwarka, New Delhi-110075,
Department: Orthopedics
Division: Unit-I
Room No.: 05, Ground Floor OPD
Phone: 011 43388888
DELHI
110075
India |
| Phone |
01143388888 |
| Fax |
|
| Email |
anjusha.singh@aakashhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aashish Chaudhry |
| Designation |
Principal Investigator |
| Affiliation |
Aakash Healthcare Super Speciality Hospital |
| Address |
Aakash Healthcare Super Specialty Hospital,
Hospital Plot, Road No.201, Sector-3, Dwarka, New Delhi-110075,
Department: Orthopedics
Division: Unit-I
Room No.: 05, Ground Floor OPD
Phone: 011 43388888
DELHI
110075
India |
| Phone |
01143388888 |
| Fax |
|
| Email |
anjusha.singh@aakashhealthcare.com |
|
|
Source of Monetary or Material Support
|
| TTK Healthcare Ltd (Ortho Division) |
|
|
Primary Sponsor
|
| Name |
TTK Healthcare Ltd (Ortho Division) |
| Address |
No. 290, SIDCO Industrial Estate,
Ambattur, Chennai-600 098 |
| Type of Sponsor |
Other [Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aashish Chaudhry |
Aakash Healthcare Super Speciality Hospital |
Hospital Plot, Road No.201, Sector-3, Dwarka, New Delhi-110075,
Department: Orthopedics
Division: Unit-I
Room No.: 05, Ground Floor OPD
Phone: 011 43388888
New Delhi
DELHI |
011 43388888
anjusha.singh@aakashhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aakash Healthcare Super Speciality Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Altius™ Buechel-Pappas Primary Total Knee replacement System (Co-Cr Mobile Bearing Knee– Cemented) |
Following up prospectively for a period of 15 years with the recruited subjects at
defined time intervals.
1 A clinical follow up is done in the Pre-operative, Post-operative years – 6 weeks,
1st, 3rd, 6th, 10th and 15th year and
2 A telephonic follow up is done in the Post-operative years - 4th, 5th, 7th, 8th, 9th,11th,12th,13th,14th years. |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects who were implanted with CE marked AltiusTM Buechel Pappas High Flex Total Knee Replacement System (Co-Cr Mobile Bearing
Knee- Cemented)
2. Subjects that underwent TKR due to degenerative joint disease (primary Osteo Arthritis, post- traumatic arthritis, avascular necrosis (Osteochondritis), Rheumatoid Arthritis, abnormal formation or alignment of the knee) |
|
| ExclusionCriteria |
| Details |
Subjects who underwent TKA without CE marked Altius (Co-Cr MobileBearing Knee- Cemented)
Subjects who underwent TKA having contraindications mentioned in IFU.
Subject has clinical conditions contributing to abnormal ambulation
Subject has undergone a previous major surgery to the study knee
Subject has active infection or sepsis (treated or untreated), not caused due to Buechel Pappas Total Knee replacement system
Subject has presence of malignant tumor such as Active lamignancy, metastatic, or neoplastic disease
Subject has conditions that may interfere with the TKA survival or outcome such as Paget’s bone disease, Charcot’s joint’s neuroarthropathy disease, muscular atrophy, metabolic disorders that affect bone regrowth, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease
Subject has any acute or chronic morbidity of vascular origin that, in the opinion of the Medical Investigator, is likely to compromise successful treatment or compliance to follow up visits
Subject has inadequate bone stock to support the device such as severe osteopenia, family history of severe osteoporosis or osteopenia or osteomalacia or lower extremity orthopaedic problems that limits function
Subject has an emotional or neurological condition that would preempt their ability or willingness to participate in the study
Subject BMI greater than 40
Pregnant Women
Subject is enrolled in another clinical study at the same time |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Device performance will be analysed by parameters such as :
a) Knee Scores (Knee society score and WOMAC scores) are collected to
clinically analyse pain and activities of daily lives for each subject in the study
population .
b) Measurement of range of motion
c) Radiographic analysis |
15 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Revision rate, Risk monitoring and Adverse event monitoring during clinical and telephonic follow up |
15 years |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="15"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of the study is to confirm the safety and performance of the device throughout its expected lifetime based on state-of-the-art; identify previously unknown complications and monitor the residual risks and contraindications; identify and analyze emergent risks on the basis of factual evidence; and ensure the continued acceptability of the benefit-risk ratio. The prospective follow-up period with the recruited subjects is 15 years at defined time intervals. |