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Total knee arthroplasty, the long and mid term follow up.

Analysis of the long term follow up of the Maxim TKA compared to the Vanguard Total Knee syatem at mid term.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28404
Enrollment
1500
Registered
2014-02-12
Start date
2014-02-07
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

osteoarthritis, knee joint is cartilage wear, Knee Arthrosis, Post-traumatic arthritis

Interventions

the Maxim total knee System (Biomet) will be compared with a cohort of consecutive patients utilizing the Vanguard total knee System (Biomet)

Sponsors

Department of Orthopaedic Surgery, Orbis Medisch Centrum, Sittard-Geleen, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Operated between January 1999 and December 2002 (Maxim group) - Operated between June 2006-december 2008 (Vanguard group) - Completed the full follow up - Deceased with a known TKA revision

Exclusion criteria

Exclusion criteria: - Patients who did not completed the full follow up - Deceased without a known TKA revision

Design outcomes

Primary

MeasureTime frame
Comparing the initial and long- and mid term survival of the Maxim and Vanguard TKA. The primary endpoint will be defined as revision of the the Maxim or Vanguard TKA for any kind. o Adverse events: all postoperative adverse events related to the implant will be evaluated and compared between both groups.

Secondary

MeasureTime frame
Comparing the initial long- and mid term clinical results of the Maxim and Vanguard TKA o Standard clinical parameters (Physical examination and Questionnaires) will be evaluated and compared between both groups.

Contacts

Public ContactM.G.M. Schotanus

Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1

m.schotanus@orbisconcern.nl+31 (0)88 4597823

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)