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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36144

Enrollment

100

Registered

2011-10-10

Start date

2011-09-23

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis primary total knee replacement

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Patients who refuse to visit the hospital for the study.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results