| CTRI Number |
CTRI/2022/03/041096 [Registered on: 15/03/2022] Trial Registered Prospectively |
| Last Modified On: |
10/03/2022 |
| 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 of Altiusâ„¢ Buechel Pappas Primary Total Knee Replacement System (Co-Cr Mobile Bearing Knee- Cemented) |
|
Scientific Title of Study
|
A single centric, open-label, observational, retrospective and prospective, Post-Market Clinical Follow-up study of Altiusâ„¢ Buechel Pappas Primary Total Knee Replacement System (Co-Cr Mobile Bearing Knee- Cemented) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AV Gurava Reddy |
| Designation |
Founder and Managing Director of ‘Sunshine Group of Hospitals |
| Affiliation |
Head of department Sunshine hospital |
| Address |
Sarvejana health care pvt. Limited
Department of orthopedics
Room no. 6
Ground floor
Sunshine hospital
PG road
Secunderabad 500003
Telangana India
Hyderabad
TELANGANA
500003
India |
| Phone |
9000040495 |
| Fax |
|
| Email |
reddymv@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AV Gurava Reddy |
| Designation |
Founder and Managing Director of ‘Sunshine Group of Hospitals |
| Affiliation |
Head of department Sunshine hospital |
| Address |
Sarvejana health care pvt. Limited
Department of orthopedics
Room no. 6
Ground floor
Sunshine hospital
PG road
Secunderabad 500003
Telangana India
Hyderabad
TELANGANA
500003
India |
| Phone |
9000040495 |
| Fax |
|
| Email |
reddymv@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AV Gurava Reddy |
| Designation |
Founder and Managing Director of ‘Sunshine Group of Hospitals |
| Affiliation |
Head of department Sunshine hospital |
| Address |
Sarvejana health care pvt. Limited
Department of orthopedics
Room no. 6
Ground floor
Sunshine hospital
PG road
Secunderabad 500003
Telangana India
Hyderabad
TELANGANA
500003
India |
| Phone |
9000040495 |
| Fax |
|
| Email |
reddymv@yahoo.com |
|
|
Source of Monetary or Material Support
|
| TTK Healthcare Limited (Ortho Division) |
|
|
Primary Sponsor
|
| Name |
TTK Healthcare Ltd Ortho Division |
| Address |
TTK Healthcare Ltd (Ortho Division) 6, Cathedral Road Chennai – 600 086 |
| Type of Sponsor |
Other [Private Medical Device Company] |
|
|
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 AV Gurava Reddy |
Sunshine Hospital |
Sunshine Hospital Penderghast Road, Paradise Secunderabad – 500003, Telangana, India.
Hyderabad
TELANGANA |
9000040495
reddymv@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sunshine Hospitals |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Altiusâ„¢ Buechel Pappas Primary Total Knee Replacement System (Co-Cr Mobile Bearing Knee- Cemented) |
• Subjects who were implanted with CE marked Altius™ Buechel-Pappas Primary Total Knee replacement System (Co-Cr Mobile Bearing Knee– Cemented) is the study population of interest.
• Data for cohort study will be collected by the medical investigators of the study or it will be gathered from existing records or databases. Wherein this being a retrospective observational cohort study, data will be validated by telephonic follow-up visits (TFU) and the eligible subjects will be recruited for prospective Clinical follow-up (CFU) study.
• Identification of previously unknown side-effects, monitoring the identified side effects and contraindications, emergent risks, assessing the survival rate, evaluation of subject satisfaction rate, these all will be examined by out-patient clinical follow-up (CFU) with eligible recruited subjects.
• To assess device performance, following assessments will be done. Measurement of deformity using radiographic examination if it will be applicable, wear of the implant, spinout, WOMAC score, and range of motion, SF 36-PCS and MCS score.
• Previously unknown side-effects will be identified and identified side effects and contraindications will be monitored.
• Emergent risks will be identified and analysed on the basis of factual evidence.
• Continued acceptability of benefit-risk ratio will be ensured.
|
| 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 BuechelPappas 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) 3. Subject agrees to provide approved written informed consent to and to follow the study visit schedule (as defined in the study protocol and informed consent document) 4. Subjects whose routine radiographic assessment is possible 5. Subject is of minimum 18 years and a maximum of 75 years of age, at the time of surgery 6. Subjects falling under at least one of below mentioned category of intended indicated use of the Implant such as : a. Someone who is skeletally mature b. Someone who has not responded to non-operative treatment (i.e. Drug or physical therapy) for a period of 6 months
c. Someone who has stable and intact ligaments for medial and lateral collateral d. Someone with intact quadriceps and hamstring mechanisms e. Someone with a poor knee score indication f. Someone whose primary surgery occurs when there is a suitable bone stock (complete cortical contact with the tibial and femoral component edges) which in turn enables sufficient seating of the components |
|
| ExclusionCriteria |
| Details |
Subjects who underwent TKA without CE marked Altiusâ„¢ (Co-Cr Mobile Bearing Knee- Cemented)
Subjects who underwent TKA having contraindications mentioned in IFU.
Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition
contributing to abnormal ambulation (including but not limited to ankle fusion, ankle arthroplasty, previous hip fracture, ipsilateral hip arthritis resulting in flexion contracture)
Subject has undergone a previous major surgery to the study knee (including osteotomy, fracture fix, medial or lateral ligament surgery)
Subject has active infection or sepsis (treated or untreated)
At the time of enrolment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
a Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
b Contralateral primary total knee or Unicondylar (Partial) knee arthroplasty
Subject weight over 150 kilograms
Subject requires revision TKA
Metabolic disorders which may impair bone formation or re-growth
Subject has any other medical condition that may overlap with the isolation of the desired parameter monitoring, as required by this study
Subjects with uncontrolled diabetes mellitus/ hypertension
Subject is expected to require bilateral TKA within 1 year following study knee replacement
Subject does not understand the language used in the Informed Consent Form
Subject is enrolled in another clinical study at the same time
Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
Subject has inadequate bone stock to support the device (severe osteopenia, family history of severe osteoporosis or osteopenia or osetomalacia) or lower extremity orthopaedic problems that limits function
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 presence of malignant tumour (Active malignancy), metastatic, or neoplastic disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety by revision rate as endpoint, complications of the subjects.
Performance by Subject Satisfaction rate: Changes in mean Knee Scores from discharge to each subsequent assessment and Pain and ADL assessment through various questionnaires |
15 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Adverse Events Reporting during prospective study period
Where, adverse event is defined as the cumulative number of a severe knee related complication or unanticipated adverse device events (UADEs) over the 15 year period of postoperative observational years.
2. Subject Satisfaction rate: Changes in mean Knee Scores from discharge to each subsequent assessment, during prospective study period [Designated as safety issue: NO] Changes in mean Knee Society Score and/or Oxford Knee score from discharge to each subsequent assessment.
3. Radiographic Evaluation (Migration, Mal-alignment if any) maximum total point motion (MTPM) of 0.2 mm (SD 0.10) during prospective study period.
4. Pain and ADL assessment through various questionnaires (Current symptoms, onset symptoms, retro patellar tenderness
|
15 year |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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)
|
20/03/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an observational retrospective and prospective
study in which the safety and performance data would be collected
retrospectively using the medical records of the Buechel-Pappas High Flex Total
Knee Replacement System (Co-Cr Mobile Bearing Knee - Cemented) implanted
subjects and subsequently their data will be validated by approaching them for
Telephonic Follow-up Visits (TFU) and the identification of unidentified side
effects, monitoring of identified side effects and contraindications, analysis
of newly emergent risks and analysis of risk benefit ratio would be done
prospectively by following up with the subjects whose data has been collected
retrospectively.
The retrospective study helps in getting greater access to
available data at a very shorter period of time. They can analyze multiple
outcomes and potentially address long term complications.
The study is designed to reflect standard clinical
practice as closely as possible because it allows the results of such a study,
to represent the true clinical outcome that would be achieved in clinical
practice from a realistic, true to life perspective |