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This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cementless Vanguard DD RP | Experimental | Patients receiving a total knee prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cementless Vanguard DD RP | Device | Patients treated with the Cementless Vanguard DD RP knee implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance | The performance will be assessed by evaluation of the rate of aseptic loosening of femoral or tibial components within 2 years follow up. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient benefits | Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS evaluates both short-term and long-term consequences of knee injury.The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. | 10 years |
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Inclusion Criteria:
Patients scheduled to undergo primary total knee replacement:
Need to obtain pain relief and improve function.
Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
A good nutritional state of the patient.
Full skeletal maturity of the patient, patients who are at least 18 years of age.
Patients of either sex.
Consent form read, understood, and signed by patient.
Exclusion Criteria:
Absolute contraindications include the following diagnoses:
Relative contraindications include:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Illi, PhD | Clinical Evidence Manager | Study Chair |
| Tobias Gotterbarm, Prof. Dr. | Kepler Universitäts Klinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler Universitäts Klinikum | Linz | 4021 | Austria |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 12, 2024 | |
| Reset | Nov 18, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 12, 2024 | Nov 18, 2024 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Patient benefits |
Patient benefit will be evaluated by means of European Quality of Life (EuroQol) in 5 Dimensions (EQ-5D) patient questionnaire. The questionnaire contains a descriptive system and the EQ Visual Analogue scale (VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. Higher EQ-5D score values indicate better outcome. |
| 10 years |
| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |