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A prospective, multi-centre, non-comparative, post-market clinical follow-up study to evaluate the survivorship, safety and performance of the FreedomĀ® Total Knee System in the treatment of approximately 450 subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis at upto 15 centers in the United Kingdom (UK). The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available FreedomĀ® Total Knee System used in total knee replacement. Subjects must meet all the study inclusion / exclusion criteria before enrolment in the study. Subjects will be requested to attend out-patients clinic for clinical follow-up (CFU) or approached for telephonic follow-up (TFU) post-operatively as mentioned below.
Clinical & Telephonic Follow-up details:
At all the clinical/telephonic follow-up visits i.e. at 8 weeks ± 1week, 1 year ± 1 month, 3 years ± 6 months, 5 years ± 6 months and 10 years ± 6 months implant survivorship and vital signs such as weight, heart rate etc including blood pressure will be recorded. Physical examination, lab measurements (optional), Radiographic assessment, concomitant medication/surgery and AE/SAE should be recorded. Also at all clinical follow ups OKS, KSS, range of motion will be recorded. The post-operative radiographic evaluations will be conducted at 0-8 weeks ± 1 week (which is considered as standard of care), 1 year ± 1 month, 3 years ± 6 months and optionally at 5 years ± 6 months, 10 years ± 6 months and Unscheduled visits, if required. The unscheduled visit is expected in some patients based on the fact that such patients might prone to complications like surgical site infections, venous thrombotic events, acute blood loss causing anaemia, nerve injury, and pain unresponsive to oral analgesics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FreedomĀ® Total Knee System | Other | A prospective, multi-centre, non-comparative, post-market clinical follow-up study to evaluate the survivorship, safety and performance of the FreedomĀ® Total Knee System in United Kingdom |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreedomĀ® Total Knee System | Device | To evaluate the survivorship, safety and performance of the FreedomĀ® Total Knee System in the treatment of subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship Kaplan-Meier estimates of survivorship for all components | Implant survivor-ship will be established by using revision surgery on the operated knee as implant failure. | At 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score which consists of 12 questions | Oxford Knee Score is a patient-reported validated outcome measure scoring from 0 - 48. It consists of 12 questions related to patient's own perception of pain and function in the knee being evaluated. Higher the score better the functioning of the knee. | At 1 year and 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vikas Salgotra, M.Phil | Contact | 91 8879063803 | vikas.salgotra@merillife.com | |
| Ashok Thakkar, Ph.D | Contact | 91 9879443584 | ashok.thakkar@merillife.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Hemant Pandit, FRCS (Orth) | Chapel Allerton Hospital and University of Leeds | Principal Investigator |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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A prospective, multi-centre, non-comparative, post-market clinical follow-up study
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| Range of Motion using a standard goniometer |
Range of motion will be assessed using a standard goniometer. It will measure the angle between maximum extension and maximum flexion that a patient can achieve in the operated knee. |
| At 1 year and 3 years |
| Knee Society Score | This score consists of points given for pain, range of motion, and stability. It Consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs.Score range of the KSS is from 0 to 100 points for each portion, with higher scores indicating better outcome | At 1 year and 3 years |
| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |