A 10 year retrospective clinical study on the balanSys bicondylar total knee endoprosthesis.

Completed

Conditions: osteoarthritis
primary total knee replacement
10005944

Registration Number: NL-OMON36144

Lead Sponsor: Mathys Medical Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patients that received the first series of the BalanSys bicondylar total knee endoprosthesis during the period of 1998 till 2003. Patients are identified through the hospital database.

Exclusion Criteria

Patients who refuse to visit the hospital for the study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary goal of this study is to determine the 10-years results of at least<br /><br>50 balanSys total knee arthroplasty (TKA) patients with respect to clinical and<br /><br>radiological outcome. To achieve these goals physical examination, knee and VAS<br /><br>scores, radiological evaluation, subjective questionnaire (KOOS) and a survival<br /><br>analysis are used.<br /><br><br /><br>Survival analysis<br /><br><br /><br>Parameters of the clinical and radiological evaluation are:<br /><br>• Range of motion (flexion and extension deficit)<br /><br>• Anterior-posterior laxity<br /><br>• KSS and KOOS<br /><br>• VAS pain and satisfaction<br /><br>• Position of the implant<br /><br>• Radiolucencies</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore, a safety analysis including complications and a survival rate of<br /><br>this prosthesis will be made.<br /><br><br /><br>Complications:<br /><br>- excessive migration of one of the two components<br /><br>- trauma<br /><br>- revision<br /><br>- mobilisation under anaesthesia<br /><br>- infection<br /><br>- patella(sub) luxation</p><br>