We hypothesize that the Vanguard TKA show similar and comparable outcome measures and survival as the Maxim TKA
ID
Bron
Verkorte titel
Aandoening
osteoarthritis, knee joint is cartilage wear, Knee Arthrosis, Post-traumatic arthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
The mid- and long term survival and patient reported outcome measures (PROMs) for this prosthesis are unknown. The revision rate of an implant is an important outcome measure in evaluating survival of a new TKA design. To make survival data comparable between different prostheses designs, revision is used as a failure end-point. The rate of ‘Revisions per 100 observed component years’ can then be calculated. According to a recent study which combined the national databases of 6 different countries there are 1.26 revisions per 100 observed component years. This number is the average revision rate for different knee designs in multiple countries. Clinical studies are valuable in addition to registry data as they can provide more details on the study population, the procedure and other aspects of the outcome. If the early survival rate of the Vanguard is known, and is comparable with other prostheses as well as its predecessor the Maxim, this would justify further use of the Vanguard TKA.
Doel van het onderzoek
We hypothesize that the Vanguard TKA show similar and comparable outcome measures and survival as the Maxim TKA
Onderzoeksopzet
5 and >10 years follow up
Onderzoeksproduct en/of interventie
the Maxim total knee System (Biomet) will be compared with a cohort of consecutive patients utilizing the Vanguard total knee
System (Biomet)
Algemeen / deelnemers
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Wetenschappers
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Patients who did not completed the full follow up
- Deceased without a known TKA revision
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4237 |
| NTR-old | NTR4382 |
| Ander register | : 13N102 |