Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is the evaluation of the clinical and radiological long-term performance of the balanSys UNI fix in a multicenter routine clinical setting.
Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the balanSys UNI fix knee prosthesis.
In total at least 100 participants in 3 clinics are included in this multicenter study.
The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery.
The following parameters will be collected during the regular clinical and radiological follow-up: Knee Society Score, Knee and Osteoarthritis Outcome Score (KOOS), radiographic evaluation and detection of adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balanSys UNI knee prosthesis | Participants treated with a balanSys® UNI knee prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balanSys UNI | Device | Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery The Knee Society Score consists of an objective score (0-100 points) and a score for function (0-100 points). A higher score means a better outcome. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation of lucent lines | The second endpoint of interest is the incidence of lucent lines measured in millimeters by means of standard X-rays. | 6-12 weeks - 10 years |
| Adverse Events and Complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
according to Eligibility Criteria
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33810795 | Derived | Tille E, Beyer F, Auerbach K, Tinius M, Lutzner J. Better short-term function after unicompartmental compared to total knee arthroplasty. BMC Musculoskelet Disord. 2021 Apr 2;22(1):326. doi: 10.1186/s12891-021-04185-w. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Documentation of complication(s):
- Description of complication with the UKA
Documentation of component revision(s) (Adverse Events):
| 6-12 weeks - 10 years |