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Study had to be terminated before first patient got enrolled due to insufficient case number.
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The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the NexGen TM Augmentation Patella. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
The Nexgen TM Augmentation Patella is intended to help compensate for significant bone loss in the patella during revision total knee arthroplasty.
One site will be involved in this study. The aim is to include a total of 25 consecutive series patients who received the NexGen TM Augmentation Patella starting from 2014 at the Inselspital Bern. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received the NexGen TM Augmentation Patella |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence and frequency of revisions, complications and adverse events. | Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. | From operation to study completion, 3-10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) | The KOOS assesses the patient's opinion about their knee and associated problems and consists of 5 subscales. Standardized answer options are given and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | From post-operative to final follow-up visit, 3-10 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be comprised of a consecutive series of patients who have been operated with the NexGen TM Augmentation Patella according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insel Spital | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| EuroQol five-dimensional Health Questionnaire (EQ-5D-5L). | The EQ-5D-5L is a generic instrument . The EQ is scored on a 0 to 100 mm scale representing "the worst..." and "the best health you can imagine", respectively. | From post-operative to final follow-up visit, 3-10 years |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |