Post-Market Clinical Follow-up study of Altiusâ„¢ Buechel Pappas Primary Total Knee Replacement System (Co-Cr Mobile Bearing Knee- Cemented)

Not Applicable

Not yet recruiting

Conditions: Osteoarthritis of knee,

Registration Number: CTRI/2022/03/041096

Lead Sponsor: TTK Healthcare Ltd Ortho Division

Brief Summary: This study is an observational retrospective and prospectivestudy in which the safety and performance data would be collectedretrospectively using the medical records of the Buechel-Pappas High Flex TotalKnee Replacement System (Co-Cr Mobile Bearing Knee - Cemented) implantedsubjects and subsequently their data will be validated by approaching them forTelephonic Follow-up Visits (TFU) and the identification of unidentified sideeffects, monitoring of identified side effects and contraindications, analysisof newly emergent risks and analysis of risk benefit ratio would be doneprospectively by following up with the subjects whose data has been collectedretrospectively.

The retrospective study helps in getting greater access toavailable data at a very shorter period of time. They can analyze multipleoutcomes and potentially address long term complications.

The study is designed to reflect standard clinicalpractice as closely as possible because it allows the results of such a study,to represent the true clinical outcome that would be achieved in clinicalpractice from a realistic, true to life perspective

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 225

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety by revision rate as endpoint, complications of the subjects.	15 year
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Sunshine Hospital
🇮🇳
Hyderabad, TELANGANA, India
Sunshine Hospital
🇮🇳Hyderabad, TELANGANA, India
Dr AV Gurava Reddy
Principal investigator
9000040495
reddymv@yahoo.com