The primary goal of this study is to determine the 10-years results of at least 50 balanSys TKA patients with respect to clinical and radiological outcome.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal of this study is to determine the 10-years results of at least
50 balanSys total knee arthroplasty (TKA) patients with respect to clinical and
radiological outcome. To achieve these goals physical examination, knee and VAS
scores, radiological evaluation, subjective questionnaire (KOOS) and a survival
analysis are used.
Survival analysis
Parameters of the clinical and radiological evaluation are:
• Range of motion (flexion and extension deficit)
• Anterior-posterior laxity
• KSS and KOOS
• VAS pain and satisfaction
• Position of the implant
• Radiolucencies
Secondary outcome
Furthermore, a safety analysis including complications and a survival rate of
this prosthesis will be made.
Complications:
- excessive migration of one of the two components
- trauma
- revision
- mobilisation under anaesthesia
- infection
- patella(sub) luxation
Background summary
For several decennia, different types of total knee arthroplasty (TKA) are used
as implants for osteoarthritis or rheumatoid arthritis knees. This is done with
very good results. Decreasing pain and increasing functional abilities of daily
life, like walking and climbing stairs, are important aims of a TKA. Many new
prostheses have been developed since that time due to a growing demand of
functionally good prostheses. They differ from each other with respect to their
geometrical design and degree of joint stability. However, industries keep
searching for even better prostheses with respect to achieved functioning,
stability and survival rates.
In 1998 Mathys Ltd Bettlach (Bettlach, Switzerland) introduced the first type
of TKP (balanSys bicondylar endoprothesis) that is implanted with a
ligament-referenced technique instead of a bone-referenced technique.
Hypothetically this should optimize the tensioning of the ligaments around the
knee and improve the knee stability in extension as well as in flexion during
daily activities as walking and stair climbing.
Study objective
The primary goal of this study is to determine the 10-years results of at least
50 balanSys TKA patients with respect to clinical and radiological outcome.
Study design
This study is performed as a cross-sectional design by retrospectively
evaluating the first series of balanSys total knee prostheses implanted during
the period 1998 till 2003 in our clinic. It is an internal quality control of a
CE-marked prosthesis 10 years after the introduction.
Study burden and risks
The patients will visit the clinic for a (standard) clinical and radiological
examination. We think that there are no risks for the patients in participating
in this study.
Güterstrasse 5
2544 Bettlach
CH
Güterstrasse 5
2544 Bettlach
CH
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37085.072.11 |