Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique

NCT ID: NCT04598568

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-15
• Study Completion Date: 2025-12-07

Brief Summary

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.

Detailed Description

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.

Conditions

Knee Arthropathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

balanSys UNI knee prosthesis

Participants treated with a balanSys® UNI knee prosthesis

balanSys UNI

Intervention Type: DEVICE

Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique

Interventions

balanSys UNI

Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Informed consent form (signed by participant and investigator)
• Primary implantation
• Age at inclusion: Between 18 and 90 years old
• Willing to participate in the follow-up

Exclusion Criteria

• Missing Informed consent form
• Known or suspected non-compliance (e.g. drug or alcohol abuse)
• Enrollment of the investigator, his/her family, employees and other dependent persons
• Patient younger than 18 years old
• Revision surgery
• Does have a known allergy to metal in medical devices
• Suffers from ACL rupture
• Pregnancy or in the breast feeding period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mathys Ltd Bettlach

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 33810795 (View on PubMed)

Other Identifiers

20140206_Protocol_V5

Identifier Type: -

Identifier Source: org_study_id